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<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Microbiologist I conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, viable titer.</li>
<li>Performs genetic analysis of microbial growth to determine Genus/Species of unknown isolates.</li>
<li>Performs gram stains.</li>
<li>Performs investigative studies for microbiome clients.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs routine data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements. Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidance is preferred.
 
SHIFT
Tuesday-Friday 2nd shift
 
MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist I, MB

<h3>Job Description</h3>
Job Description
The field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. 
WORKING AT GENEZEN
Many people have worked in environments where you feel like just another nameless part of an enormous machine. Genezen is different. We want our employees to be innovative, collaborative problem solvers who are dedicated to meeting the challenges of working at a fast-growing company. We are dedicated to empowering our employees to be their best and making Genezen a rewarding place to work. Every employee contributes to the success of the company and you can be part of that team.
JOB SUMMARY
The QC Microbiology Supervisor will lead, plan, organize, guide, and be responsible for the coordination/performance of the QC Microbiology Laboratory Operations,
This position is located in Lexington, MA and will supervise the 2nd shift which will operate M-F from 1:00-9:30pm. The Supervisor will report to the Manager of Microbiology.
ESSENTIAL JOB FUNCTIONS
<ul>
<li>Oversee the execution of monitoring for controlled environments and utility systems within the Manufacturing Facility. Ensure execution is compliant with appropriate regulatory requirements and guidelines using approved Standard Operating procedures (SOPs). </li>
<li>Serve as an SME and provide guidance and support for critical QC Microbiology assays and methods.</li>
<li>Provide leadership, coaching, mentoring and training of QC Microbiology staff, aiding in employee development and performance. </li>
<li>Ensure QC Microbiology testing is completed, reviewed, and reported in a compliant manner and results are timely delivered to clients.</li>
<li>Maintain all aspects of QC Microbiology day-to-day operations and scheduling to align with all aspects of GXP requirements.</li>
<li>Manage data and trending in support of environmental monitoring and utility monitoring reports.</li>
<li>Represent QC Microbiology at cross-functional meetings and interact with internal customers, clients and external vendors.</li>
<li>Perform QC Microbiology testing as required, including bioburden, endotoxin of in-process, product and utility samples. </li>
<li>Perform EM and utility related monitoring, as necessary. </li>
<li>Identify continuous improvement opportunities. Design, implement and maintain resulting systems.</li>
<li>Ensure a safe working environment and compliance with OSHA, EHS, Quality, and cGMP procedures and policies is maintained.</li>
<li>Author and revise SOPs, protocols and technical reports to meet industry standards, as necessary.</li>
<li>Oversee QC sample submission and processing activities, and ensure testing is performed accordingly. </li>
<li>Initiate and collaborate on change controls, deviations, and Out of Specification (OOS), Out of Tolerance (OOT) investigations related to QCM and assist with non-conformance investigations. </li>
<li>Serve a system owner of QC Microbiology controlled temperature units, respond per on-call schedule to CMS alarms, including off-hours and weekends </li>
</ul>
SPECIAL WORK REQUIREMENTS
<ul>
<li>Ability to troubleshoot equipment and microbiological testing methods.</li>
<li>Ability to adapt to schedules and priorities changes based on business needs</li>
<li>Experience creating comprehensive department schedules</li>
<li>Leadership experience within a high functioning team</li>
<li>Other duties, as assigned. </li>
</ul>
KNOWLEDGE, SKILLS AND EXPERIENCE
EDUCATION / CERTIFICATIONS / LICENSES
Essential/Desired
Bachelor's degree in microbiology; other related science will be considered. 
Essential
ON-THE-JOB EXPERIENCE

5-15 years of Microbiology laboratory-based experience in a QC testing capacity within a cGMP setting. 
Required
Prior supervisory experience. 
Desired
SKILLS / ABILITIES

Excellent microbiological skills and technical experience in GXP environment. 
Essential
Thorough understanding of industry and regulatory testing requirements for QC Microbiology.
Essential
Computer literacy (MS Word, Excel, and LIMS)
Essential
Must possess excellent communication and organizational skills.
Essential
Detail-Oriented
Essential
Self-organized
Essential
Work Environment:
<ul>
<li>Regularly sit or stand for long periods of time </li>
<li>Work in a BSL 2 environment</li>
</ul>
Movement:
<ul>
<li>Work in a BSL 2 environment</li>
</ul>
Lifting
<ul>
<li>Frequently lift and/or move up to 25 pounds </li>
</ul>
Vision
<ul>
<li>Frequently utilize close vision and the ability to adjust focus</li>
</ul>
Communication
<ul>
<li>Frequently required to communicate by talking, hearing, using telephone and e-mail</li>
</ul>
GENEZEN'S CURES VALUE-BASED COMPETENCIES
Committed to Science We are committed to scientific excellence, staying current with industry developments, making data-driven decisions, and pursuing innovation to advance healthcare.
Urgency in action for the patients We operate with urgency and a commitment to delivering timely treatments to patients by accelerating our partners' programs.
Resilience &amp; Grit in operations We are committed to overcoming challenges, learning from failures, and persistently striving for success. 
Execute with Excellence &amp; Integrity We are dedicated to delivering quality results and upholding ethical principals.
olutions driven for our partners We are committed to being a proactive, collaborative, creative and open-minded partner.
GENEZEN'S BENEFITS
<ul>
<li>Paid vacation days, amount based on tenure</li>
<li>Paid sick time</li>
<li>10 observed holidays + 2 floating holiday + 1 volunteer day</li>
<li>401(k) plan with company match up to 6% of salary, vested immediately</li>
<li>Share Appreciation Rights</li>
<li>Choice of several healthcare plans</li>
<li>FSA and HSA programs</li>
<li>Dental &amp; vision care</li>
<li>Employer-paid basic term life/personal accident insurance</li>
<li>Voluntary disability, universal life/personal accident insurance</li>
<li>Accidental Death &amp; Dismemberment (AD&amp;D) Insurance</li>
</ul>
ADDITIONAL DETAILS
<ul>
<li>Nothing in the job description for this role restricts management's right to assign or reassign duties and responsibilities to this job at any time.</li>
<li>This position requires a criminal background check.</li>
<li>Genezen is an Equal Opportunity Employer.</li>
<li>Genezen participates in EVerify.</li>
<li>Genezen is interested in every qualified candidate who is eligible to work in the United States; however, we are not able to sponsor visas.</li>
</ul>
Genezen has operates two locations: one in Fishers, Indiana and the second in Lexington, Massachusetts. 
Fishers is a suburb of Indianapolis. Fishers was named the #1 place to live in the US by Money Magazine in 2017 for its livability, safety and entrepreneurship. Fishers is one of the fastest growing communities in Indiana and is dedicated to supporting a high quality of life for all its residents. Nearby Indianapolis is home to professional and college sports teams, the Indy 500, a growing art community and the world's largest children's museum--to name just a few reasons why this area is a great place to live.
Lexington, Massachusetts, located just northwest of Boston, is renowned as a historic suburb with a rich cultural heritage. It boasts picturesque New England charm, tree-lined streets, and a vibrant community. Known for its pivotal role in the American Revolution, Lexington offers visitors and residents alike a blend of historical landmarks, modern amenities, and a strong sense of community pride.

QC Supervisor, Microbiology (2nd Shift, 1pm-9:30pm)

<h3>Job Description</h3>
Job Description
DIVISION: Operations
DEPARTMENT: Laboratory Services
UNION/ GRADE: Unit 9/Grade 18
TO VIEW OUR BENEFITS PLEASE CLICK ON THE LINK! - <a href="https://www.mwra.com/about-mwra/careers" target="_blank">https://www.mwra.com/about-mwra/careers</a>
BASIC PURPOSE:
Performs a variety of moderately complex microbiological, biological, and chemical analyses using prescribed procedures on water, wastewater and air.
SUPERVISION RECEIVED:
Works under the general supervision of a Laboratory Supervisor.
SUPERVISION EXERCISED:
None.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
<ul>
<li>Performs a wide range of moderately complex microbiological, biological, and chemical laboratory analyses and field tests and operates all related equipment, assuring adherence to Standard Operating Procedures (SOPs).</li>
<li>Assists in studies and investigations by performing microbiological analyses and tests as directed.</li>
<li>Provides technical direction to technicians and laboratory support personnel by reviewing and confirming the results of routine laboratory and field tests and providing instruction to assure conformity to SOPs.</li>
<li>Performs set-up, maintenance, calibration and minor troubleshooting duties on a variety of standard instrumentation and oversees technicians in their performance of routine equipment maintenance duties.</li>
<li>Maintains a current knowledge of new analytical procedures and equipment.</li>
<li>Follows SOPs to maintain accurate, reliable data, and to effect the efficient transfer of the data in the LIMS system.</li>
<li>Utilizes standard applications software and prepares accurate statistical and graphics displays, as instructed. May assist in the development or modification of software.</li>
<li>Prepares detailed notes and assists with technical reports. May write assigned portions.</li>
<li>Prepares purchase requisitions to reorder standard supplies and materials, and may lead or perform duties to take inventory of supplies and equipment parts.</li>
<li>Provides instruction to technicians in laboratory safety, assures that safety procedures are followed and maintains clean and safe work areas.</li>
</ul>
SECONDARY DUTIES:
Performs related duties as required.
MINIMUM QUALIFICATIONS:
Education and Experience:
<ul>
<li>A four (4) college degree in microbiology, biology, chemistry or a related field; and</li>
<li>At least (1) year of experience in microbiological/chemical analysis, quality control and statistical techniques; or</li>
<li>Any equivalent combination of education and experience.</li>
</ul>
Necessary Knowledge, Skills and Abilities:
<ul>
<li>Thorough knowledge of state of the art modern microbiological/chemical laboratory methods, procedures, materials and equipment.</li>
<li>Skill in the operation of the listed tools and equipment.</li>
<li>Thorough knowledge and experience in proper sampling techniques and analytical procedures.</li>
</ul>
SPECIAL REQUIREMENTS:
<ul>
<li>A valid Class D Motor Vehicle Operators License.</li>
<li>TOOLS AND EQUIPMENT USED: Laboratory equipment and instruments, telephone, personal computer including word processing and other software, copy and fax machines.</li>
</ul>
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.
While performing the duties of this job, the employee is frequently required to use hands to finger, handle, feel or operate objects, tools, or controls and reach with hands and arms. The employee frequently is required to stand and talk or hear. The employee is occasionally required to walk, sit, climb, balance, stoop, kneel, crouch or crawl.
The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move more than 25 pounds. Specific vision abilities required by this job include close, distance, color, peripheral vision, depth perception and the ability to focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
While performing the duties of this job, the employee occasionally works in outside weather conditions. The employee is occasionally exposed to wet and/or humid conditions. The employee is occasionally exposed to fumes or airborne particles, toxic or caustic chemicals.
The noise level in the work area is usually loud in field settings, and moderately quiet in a laboratory environment.
Massachusetts Water Resources Authority (MWRA) is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, national or ethnic origin, age, religion, disability, sex or gender, sexual orientation, gender identity or expression, genetics, or veteran status.
 Job Posted by ApplicantPro

Microbiologist I

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Manager of Microbiology is responsible for the day-to-day and strategic functions of the QC Microbiology and Microbiology- Validation groups in Salem, NH. The Manager is responsible for providing technical support, scheduling and prioritizing work to meet customer expectations, and ensuring all work is performed in compliance with the quality, health, and safety objectives of the company. Provide technical support to Microbiologists and Client Services team members as needed. Responsible for all aspects of staff management including training, hiring, conducting feedback sessions, employee development, retention and engagement, disciplinary actions, and terminations. The Manager has direct responsibility for improving production efficiency and helping to meet the financial goals of the Microbiology department.
The essential duties and responsibilities of this position include the following. Other duties may be assigned as needed.
 
PRIMARY DUTIES AND RESPONISIBITIES
<ul>
<li>Leads the development and implementation of process improvement initiatives that promote increased productivity for the QC Micro and Validation groups.</li>
<li>Coordinates work projects to appropriately prioritize laboratory workload to meet client requirements as related to quality, on-time performance and TAT (Turnaround Time).</li>
<li>Distributes work to staff in order to maximize productivity.</li>
<li>Maintains quality performance metrics, conducts routine metrics review and root cause analysis in collaboration with the microbiologists.</li>
<li>Devises and develops processes and methods for the solution of technical problems.</li>
<li>Trains, mentors and supervises staff on an as needed basis.</li>
<li>Confers with Quality Assurance and Microbiology Director to design and/or improve standard operating procedures and/or training programs.</li>
<li>Responsible for scheduling work in support of maintaining all deadlines.</li>
<li>Ensures that laboratory supplies, consumables, standards are available to perform the analyses within the required project turnaround time.</li>
<li>Communicates project delays, quality and or technical issues to the Microbiology Director, and/or Client Services/Sales Team, as needed.</li>
<li>Reviews lab nonconformance (investigation and deviations) with microbiologists. Conducts root cause analysis and implements solutions in collaboration with the team.</li>
<li>Manages all aspects of office and lab operations as related to operating costs.</li>
<li>Responsible for the interviewing and the hiring of employees.</li>
<li>Provides regular ongoing performance feedback while serving as a coach and mentor.</li>
<li>Responsible for developing and communicating goals to microbiologists.</li>
<li>Ensures all work is performed in compliance with Standard Operating Procedures, Good Manufacturing Practices, Regulations of the Food and Drug Administration, Company, Client and Pharmacopeial Methodologies.</li>
<li>Follows all safety rules and regulations.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Maintain a clean and orderly laboratory environment.</li>
<li>Proper handling of hazardous waste in compliance with the Company and hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a Masters and/or Bachelors degree in Microbiology or a related discipline is required. Must have laboratory experience with a minimum of 5 years of related work experience. Knowledge of cGMPs and related compliance regulations and guidances required.
Must have experience with the various products and services the Company offers including LIMS and ELN and Microbiology.
This position requires a self-starting, motivated person who possesses excellent interpersonal skills; who is able to assume a leadership role in the organization; and, who is able to effectively interact with all departments within the company and with client personnel.
 
MINIMUM SKILLS REQUIREMENT
<ul>
<li>Demonstrated skills in laboratory techniques.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiology Manager

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The Microbiologist conducts validation and feasibility testing for quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and BA, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Performs validation testing to analyze samples to determine an accurate microbiological procedure for the following analyses: Microbial enumeration methods, absence of specified microorganisms, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).</li>
<li>Performs Disinfectant Efficacy testing for clients facilities utilizing specific disinfectants, surfaces, and organisms determined by the clients.</li>
<li>Perform feasibility work with guidance from USP and BA SOPs. Being able to work independently with little to no guidance to figure out and apply test methods to different products and materials.</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Writes validation reports and client protocols for QC Micro to follow for routine testing.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.</li>
<li>Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred.
 
SHIFT
WED-SAT 1ST SHIFT

MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist I, VD

<h3>Job Description</h3>
Job Description
Principal Biostatistician
Statistics &amp; Data Corporation (SDC), a specialized contract research organization (CRO) headquartered in Arizona, delivering top-tier clinical trial services to pharmaceutical, biologic, and medical device/diagnostic companies since 2005. SDC providing a technology enabled service offering to provide clients with both clinical services expertise, as well as the technology they need to be successful in their clinical trials.
Job Location: AZ/MA/NC
Job Summary
Apply a high level of technical expertise to help guide and develop the more junior biostatistics staff members. Serve as a lead statistician on clinical studies and provide senior level peer review of work being accomplished by other biostatisticians in the department. Maintain the statistical and analytical integrity of clinical trials analyzed by SDC. Actively participate in writing statistical sections of protocols, preparing statistical analysis plans, preparing data deliverables for clinical study reports, interpreting analysis results, writing statistical sections of clinical study reports, and participating in meetings with drug regulatory agencies as required. Support business development and project management with strategic planning, proposals, pricing, and timeline planning.
Primary Responsibilities
• Serve as an internal consultant for biostatistics analysis tools and methods
• Serve as a subject matter expert during client and vendor meetings for biostatistics analysis support
• Actively support business development in capabilities presentations to prospective and current clients
• Effectively manage assigned clinical study budgets for biostatistics analysis support
• Develop, coach and mentor junior biostatistics department personnel
• Act as the lead statistician on clinical research projects and help with SAS programming
• Provide statistical expertise for study design of clinical trial protocols
• Write statistical methods section of the study protocol, as needed
• Write statistical analysis plans ensuring appropriate regulatory requirements and study objectives defined in the study protocol are followed
• Review CRFs to ensure consistency with protocol and statistical analysis plan (SAP)
• Program summary tables, data listings and graphical representations of clinical trials data
• Perform all analyses defined in the statistical analysis plan as well as any post-hoc analyses and relevant exploratory analyses of clinical trial data
• Prepare/review key sections of clinical study reports and various regulatory documents
• Perform statistical QC of all department outputs including analyses and clinical study reports
• Provide statistical support to answer questions from external clients (such as FDA, Investigators)
• Contribute to the development, maintenance, and training of standard operating procedures (SOPs)
• Represent the biostatistics department at regulatory meetings, sponsor meetings, and any other multifunctional meetings, as needed
• Manage biostatistics timelines, budgets, and client expectations
• Adhere to all aspects of the Statistics &amp; Data Corporation’s quality system
• Comply with Statistics &amp; Data Corporation’s data integrity &amp; business ethics requirements
• Perform other related duties incidental to the work described herein
• Adherence to all essential systems and processes that are required at SDC to maintain compliance to business and regulatory requirements
The above statements describe the general nature and level of work being performed by individuals assigned to this classification. This document is not intended to be an exhaustive list of all responsibilities and duties required of personnel so classified.
Requirements
Required Skills
• Effective leadership, budget forecast and implementation skills
• Excellent analytical skills, with the ability to process scientific and medical data
• Able to work independently and in teams
• Project management abilities including analytical evaluation, organization, delegation, flexible team management, negotiating and resource management skills
• Excellent knowledge of statistical programming
• Expertise in manipulating and analyzing SAS data
• Able to identify data issues, present problems, and implement solutions.
• Capable of communicating technical concepts clearly, concisely, and understandably to non-statistical colleagues and clients
• Excellent organizational and time management skills, with the ability to multi-task
• Familiarity with clinical trial design and analysis activities and basic knowledge of regulatory guidelines (FDA/CFR, ICH/GCP)
• Strong interpersonal communication and presentation skills
• Able to effectively collaborate across cross-functional teams
• Focus on quality at all times and in all situations
Education or Equivalent Experience
• A Master’s degree in biostatistics, statistics or other related, scientific field and at least eight years of relevant professional experience or a combination of education and experience.
Benefits
Why SDC
SDC is a team of diversified professionals who deliver exceptional Biometric Services, Consulting, and Technology Solutions to pharmaceutical, biologic, and medical device/diagnostic companies. Since 2005 our purpose has been to partner with sponsors to provide high quality and experienced team members to develop great medicines that save lives and cure diseases in the most efficient manner possible. Our global team operates as a value partner to our clients by fulfilling their needs as our own and delivering exceptional results. We are a specialty CRO in that we provide scalable service offerings, focused services area specialists, efficient project timelines, optimal technology solutions, and proven success and experience. Our commitment to our clients is the same commitment to our employees. By offering strong benefits including competitive pay, generous time off, attainable career advances, positive work/life balance and 401k matching (US), we are able to attract some of the most talented people in the industry. 
•We are committed to developing our employees. We recognize achievements, provide growth opportunities and career advancement, offer a flexible work schedule, engaging work culture and employee benefits. 
•We are passionate about our company culture. Our recognition program is directly tied to our core values of Energy, Integrity, Engagement, Innovation, Ownership, and Commitment. 
•We strive to provide a place of belonging to our employees with fun and engaging activities from SDC’s culture club.
•We are constantly growing and innovating to support our client and employee needs. Global in nature, we bring diverse perspectives enabling our growth in this ever-evolving industry. 
•With a proven track record, SDC has been successfully executing client clinical programs since 2005.
Take a look at how you can join our team!
#LI-Hybrid

Principal Biostatistician

<h3>Job Description</h3>
Job DescriptionSalary: 
JOB SUMMARY
The QC Microbiologist conducts quantitative and qualitative analysis of pharmaceutical products according to FDA, cGMP and Boston Analytical, Inc. Standard Operating Procedures. Duties will include analysis of pharmaceutical products through compendial methods and client specific test protocols.
 
PRIMARY DUTIES AND RESPONSIBILITIES
<ul>
<li>Prepares and analyzes samples to determine microbiological quality through the following analyses: Microbial enumeration methods, absence of specified microorganisms, Sterility, endotoxin, and water quality analysis (bioburden, TOC, Conductivity).</li>
<li>Documents work in a clear and organized manner.</li>
<li>Revises procedures and ELNs under close supervision.</li>
<li>Follows all safety rules and regulations and conducts periodic safety audits.</li>
<li>Follows all cGMP rules and regulations.</li>
<li>Under close supervision confers with Microbiologists and other client personnel regarding research, procedures performed, related results and prepares reports.</li>
<li>Under close supervision will be trained to become proficient at assigned tasks in order to become subject matter experts.</li>
<li>Performs routine data generation and problem solving with a minimal rework.</li>
<li>Works under close supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and the regulations of the Food and Drug Administration.</li>
<li>Ensures all work performed strictly adheres to Company, client and Pharmacopeial methodologies.</li>
<li>Performs system maintenance and calibrations to ensure equipment is operating with specified requirements.</li>
<li>Proper handling of hazardous waste in compliance with the Company and DES hazardous waste rules.</li>
</ul>
REQUIREMENTS &amp; QUALIFICATIONS
Qualifications include a BA or BS degree in Microbiology or related science discipline with 0-2 years of related experience is required. Knowledge of cGMP and related compliance regulations and guidances is preferred.
 
SHIFT
Sunday-Wednesday, 1st shift.
 
MINIMUM SKILLS REQUIREMENTS
<ul>
<li>Must have the ability and skill to perform the detailed job requirements noted above competently, safely and proficiently.</li>
<li>A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel.</li>
<li>Must have excellent organizational, verbal communication and technical documentation skills.</li>
<li>Solid computer skills.</li>
<li>Knowledge of safe laboratory practices, including the proper procedures in handling chemicals and samples.</li>
<li>Must be a team player with integrity and concern for the quality of Company products, services and staff members.</li>
</ul>

Microbiologist QC I

<h3>Job Description</h3>
Job Description
Location: Devens MA
Reports to: Director, Separations Sciences
FLSA Status: Exempt
Summary:
The Principal Application Scientist is responsible for conducting chromatography services, developing chromatographic methodology and providing technical insights to YMC America customers. This is a hands-on lab position that will utilize YMC chromatography products to conduct lab services mainly at internal YMC facilities and occasionally externally at customer sites. The developed insights will be used for promoting YMC products and for technical support / troubleshooting of clients who use YMC products.
The Principal Application Scientist will also be responsible for technical support of YMC chromatography media, technology and lab systems. They will be a “face of YMC technology” at customer sites and conferences. This will include support of instrument rentals, feasibility studies, methods development and other activities that enable customers to solve purification dilemmas by leveraging YMC technologies.
Responsibilities:
<ul>
<li>Conduct certain YMC America’s lab studies (Insight Services) under the direction of the Director, Separations Sciences. Lab facilities include those in Devens, MA and certain university collaborations. This role includes some instrument maintenance and support for the in-house lab/pilot facility.</li>
<li>Maintain a high-level working knowledge of YMC chromatography products (resins, columns, services and systems) and impart that understanding in the support of sales as a non-sales technical expert.</li>
<li>Assist in internal and external bench chromatography (CUBE) and pilot (TWIN) studies in the America’s. This includes the occasional on-site and remote set-up and training of lab instruments (Contichrom CUBE).</li>
<li>Influence potential customers to recognize the value and benefits of YMC resin and system technologies in a non-sales role.</li>
<li>Attend conferences and technical meetings as a representative of YMC America. </li>
<li>Deliver occasional presentations, papers and / or posters at industry events. Generate reports on competitive techniques and technologies.</li>
<li>Co-author white papers / applications notes that can be used to promote understanding of YMC products.</li>
<li>Assist in the review of results from external users of YMC products and provide feedback on how to better use the product in question.</li>
<li>Troubleshoot existing customer separation problems when their technical experiences / insights are applicable.</li>
<li>Play an active role in the development of new applications for existing analytical and prep products. </li>
</ul>
Required Experience &amp; Knowledge:
<ul>
<li>Bachelor’s degree in chemistry, chemical engineering, or a related field.</li>
<li>A minimum of three years’ experience as a lab scientist with an emphasis on Chromatography. </li>
<li>Must have a solid knowledge of chromatographic theory, techniques and associated instruments.</li>
<li>Hands-on experience with prep chromatography techniques and instrumentation. Particularly, as applied to peptide and/or oligonucleotide pharmaceutical compounds.</li>
<li>Ability to prioritize obligations, make self-directed decisions, multi-task, and function effectively with multiple deadlines. </li>
<li>Must be willing to travel up to 20% of the time.</li>
<li>Must possess strong documentation and technical writing skills and be able to apply relevant scientific principles and practices.</li>
<li>Must communicate clearly and concisely across levels, both orally and in writing, with a strong command of the English language.</li>
<li>Must be able to work under minimal supervision and able to work independently and in a team environment.</li>
</ul>
Preferred Skills and Experience:
<ul>
<li>A post-undergraduate degree in Chemistry, Chemical Engineering, or a related degree.</li>
<li>Experience of 3+ years performing lab services preferably related to the pharmaceutical industry, including some form of lab management responsibilities.</li>
<li>Working knowledge of automation systems for lab and production equipment in the life sciences related field.</li>
<li>Demonstrated experience in writing technical papers. Past publication experience is a plus.</li>
<li>Working knowledge of both large molecule biopharmaceutical processes and small molecule processes.</li>
<li>Language/communication skills with Spanish, German or Japanese is preferred.</li>
</ul>

PRINCIPAL APPLICATION SCIENTIST

<h3>Job Description</h3>
Job Description
Lantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. 
Lantheus is an entrepreneurial, agile, growing organization that provides innovative diagnostics, targeted therapeutics, and artificial intelligence (AI) solutions that empower clinicians to find, fight and follow disease. At Lantheus our purpose and values guide our behaviors in all interactions and play a vital role in creating a dynamic environment that contributes to our success. Every employee is crucial to our success; we respect one another and act as one knowing that someone’s health is in our hands. We believe in helping people be their best and are seeking to bring together a diverse group of individuals with different viewpoints and skill sets to be a part of a productive and inclusive team. 
Position Summary
Operates with a high degree of independence and is adept at conceptually outlining development, qualification, and life-cycle management studies with a focus on process analytical concepts to monitor and control critical steps in the manufacturing process of radiopharmaceuticals, ensuring consistent quality and safety meet current regulatory requirements on radiopharmaceutical drug products. Drives development and validation of new and improved radiochemical process controls in commercial processes; implements analytical methods and/or physicochemical characterizations in support of process development; radiolabeling processes and detection; and/or technology transfer to Contract Organizations. These efforts support the economical, efficient, and safe manufacture of radiolabeled precursors, bulk drug substances, and/or drug products. Lead PET CMO analytical operations and execution from late-stage development through site qualification. Engages in the development of complex strategies and testing requiring implementation of sophisticated, specialized scientific knowledge and advanced lab techniques, with latitude for independent judgment, decisions, and action. Radiopharmaceutical experience is preferred.
Essential Functions
<ul>
<li>Plans and drives multiple projects, requiring initiative and innovation, within Lantheus’ Quality system and governing regulations. Works on complex problems of diverse scope while serving as a technical analytical SME. Identifies, analyzes, and interprets project results. Evaluates results and examines implications to program.</li>
<li>Participate in technical troubleshooting sessions for processes and products manufactured in-house and at CMOs as needed and in investigating atypical/OOS results.</li>
<li>Performs routine laboratory, including working with radioactive materials, or oversees these actions at PET CMOs. Demonstrates ability to follow SOPs and Lantheus’ procedures as written. Tracks laboratory supplies and replenishes when needed. Maintains laboratory notebook, record keeping, and laboratory safety in accordance to common industry GLPs and Lantheus’, or CMO site, procedures.</li>
<li>Exhibits an increased understanding of radiochemistry, its regulations, stays aware of new scientific developments, and is able to incorporate these into their development/qualification activities.</li>
<li>Communicates scientific ideas and information in an appropriate and timely manner. Employs active listening skills to maintain clear communication to others. </li>
<li>Provides technical support to further program and Qualification activities at CMO/CROs; Authors technical transfer protocols and ensure acquired results are collected and documented according to cGMPs; Assists in completion of close-out reports and appropriate Change Controls. </li>
<li>Shows the ability and willingness to continually enhance functional and technical expertise. Assesses own strengths/ needs and learns from experience and feedback in order to continually enhance the level of functional and technical expertise. Takes action on developmental opportunities.</li>
<li>Accurately documents results in established formats. Able to write basic reports clearly and succinctly. Prepares written reports on all phases of laboratory and/or field experimental work. Presents results to colleagues at scientific meetings and to multidisciplinary audiences in program meetings. Writes comprehensive reports based on literature, lab and field data.</li>
<li>Maintains current knowledge of, and ensure all work activities are conducted in compliance with the full range of related internal and external systems, technology, regulatory requirements and related policies and procedures. Follows procedures to support intellectual property protection. May be responsible for preparing and defending patent disclosures and applications.</li>
<li>Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety &amp; environmental hazards.</li>
<li>Actively demonstrates the Lantheus values of Helping people be their best; Respect one another and act as one; Learn, adapt, and win; Know someone’s health is in our hands; and Own the solution and make it happen.</li>
</ul>
Typical Minimum Skills and Experience and Education 
<ul>
<li>Degree in Chemistry, Engineering, or related discipline or equivalent relevant industry experience.</li>
<li>Requires a minimum of a Ph.D. degree and 5+ years relevant industry work experience or a M.S. degree and 8+ years relevant work experience or a B.S. degree and 10+ years relevant industry work experience.</li>
<li>Scientific knowledge and experience in the technical aspects of radioanalytical chemistry and radiopharmaceutical process development and expertise in GMP documentation requirements with a working understanding of 21CFR 212 regulatory guidelines.</li>
<li>Previous experience working with radiopharmaceuticals and CMOs strongly preferred.</li>
</ul>
Other Requirements
<ul>
<li>Exceptional knowledge of scientific field of specialization. Familiar with Code of Federal Regulations parts 210 and 211 and supporting regulatory inspections.</li>
<li>Demonstrated skills in leading projects on an assigned team.</li>
<li>Able to properly handle and minimize exposure to potentially hazardous chemical, or radiological materials. Required to follow all safety procedures, and use personal and protective equipment provided.</li>
<li>Demonstrated competence in the design and documentation of complex experiments focused on a specific topic. Expanded scope to include multiple related questions for a given program.</li>
<li>Routine and or frequent lifting, with reasonable accommodations.</li>
<li>Demonstrated ability to effectively communicate ideas and information, both in oral and written form.</li>
<li>Travel (including international) is highly anticipated.</li>
</ul>
Lantheus is an equal opportunity employer that provides a workplace free from discrimination. All qualified applicants and employees are considered without regard to race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any other characteristic protected by law.
Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the Lantheus Talent Acquisition team at <a href="mailto:talentacquisition@lantheus.com" target="_blank">talentacquisition@lantheus.com</a>.

Senior Scientist II PET Analytical Development

<h3>Job Description</h3>
Job Description
Summary:
As a senior member of NCF’s Department of Ecological Research, Stewardship and Restoration, the Coastal Wetlands Research Ecologist is responsible for executing the Coastal and Wetland Ecology Research Program. They oversee research on the ecology of wetlands and coastal habitats related to restoration, habitat quality, ecosystem function, and resilience. Broad project topics include but are not limited to baseline coastal wetland habitat health, effectiveness of nature-based responses to climate change impacts, understanding impacts of climate change on coastal habitats, habitat restoration for function and improved resilience, and broad ecological research within the Program focus. 
Under the direction of the Vice President of Science and Stewardship, the Coastal Wetlands Research Ecologist is responsible for developing targeted inventory, monitoring and research projects related to their Program’s areas of interest (as described above) as well as overseeing and participating in the successful execution of these projects. They provide oversight, planning, and logistical support to NCF’s year-round Coastal Research Technician and related seasonal field staff. They also oversee and may participate in related research conducted by outside research partners working on NCF properties, work cooperatively on joint projects with other local and regional conservation organizations, and represent NCF on key committees, working groups and the like related to their program’s areas of expertise. 
The Coastal Wetlands Research Ecologist serves as a key senior member of the NCF Department of Ecological Research, Stewardship and Restoration, working closely and coordinating with senior level staff from the Wildlife Ecology, Plant Ecology and Botany, and Land Management and Stewardship Programs. Furthermore, they coordinate education, mentoring and outreach programming relevant to coastal wetland ecology in partnership with NCF’s Interpretive Education staff, contribute content to NCF’s social media, website, newsletters, annual reports, and other publications and provide team-oriented support for the successful implementation of NCF’s overall mission. 
Specific Responsibilities:
Staff Management
1. Supervise the Coastal Research Technician; assists in supervising seasonal field assistant(s) and volunteers working on coastal and wetland ecology related projects.
Coastal and Wetland Ecology Research
In coordination with the Vice President of Science and Stewardship, oversee all aspects of the Coastal and Wetlands Ecology Program of the NCF Department of Ecological Research, Stewardship and Restoration, including but not limited to the following: 
1. Provide leadership and strategic planning for current and future goals and projects related to the Program.
2. Develop and oversee the implementation of research, restoration and monitoring projects related to coastal and wetlands ecology and potential coastal resilience initiatives on NCF properties, including:
o Project design, field work, data collection and analysis, and interpretation and presentation of results in reports, scientific publications, and professional presentations.
o Staff oversight, delegation and support for all aspects of project implementation needed for success.
o Relevant grant opportunity identification and application for funding as opportunities arise.
3. Identify and target potential partnerships with academic and research institutions that complement the focus of the Coastal and Wetland Ecology Program, as well as the vision, mission and strategic goals of the overall department.
4. Represent NCF’s wetland ecology interests and coastal resilience initiatives at appropriate local and regional committees, working groups, professional networks and the like when appropriate.
5. Provide oversight and participate as appropriate in research conducted by outside investigators working on Foundation properties.
Stewardship, Land Management and Restoration
1. Play a leadership role in identifying, planning and implementing projects focused on wetland restoration and coastal resilience. 
2. Contribute expertise and collaborate on the development, planning and implementation of stewardship, land management and restoration projects on NCF properties.
3. Collaborate on joint projects with local and regional conservation organizations and governmental agencies involved in coastal resilience and coastal and wetland ecology projects, as needed.
4. Coordinate with NCF’s Department of Land Management regarding the need for land management staff and equipment support for Coastal and Wetland Ecology Program projects, as needed. 
Interpretive Education and Community Relations
1. Contribute content related to Coastal and Wetland Ecology Program projects to NCF’s website, social media outlets, newsletters, publications, press releases, video productions and the like, as well as outside requests for content.
2. Develop and participate in NCF’s interpretive education excursion programming aimed at providing experiences that educate participants in coastal resilience and wetland ecology, as well as other outside opportunities as they arise.
Development, Fundraising and Donor Relations
1. Work with the Vice President of Science and Stewardship to identify grant opportunities, write proposals and manage grant awards supporting NCF’s overall research, stewardship and restoration projects.
2. Participate as a senior department representative at fundraising, outreach and donor cultivation events to provide support for the Development Department’s efforts to connect donors with aspects of NCF’s mission that complement their interests.
Dates/Hours:
This is a full-time, year-round exempt position beginning in late-July 2025; exact dates are somewhat flexible. Hours are 40 hours per week, generally during normal business hours from Monday through Friday. Daily hours may be somewhat variable depending on particular projects: early-morning and late-night fieldwork may be required depending on weather, tides, etc. Weekend work will occasionally be required for certain field projects and non-profit events.
Field Work Environment:
A component of this position involves field work involving hiking, standing, bending, kneeling, and hauling field gear. Applicants should be accustomed to occasionally working in inclement weather or at sites with variable terrain, poison ivy, biting insects, etc. such as salt marshes and other wetlands. Nantucket is an area with a high incidence of tick-borne disease so precautions to minimize risk are encouraged. 
TO APPLY:
Applications accepted ONLY through our hiring website: <a href="https://apply.workable.com/nantucket-conservation-foundation/" target="_blank">https://apply.workable.com/nantucket-conservation-foundation/</a>
Application Packet: ONE PDF DOCUMENT including cover letter, resume, contact information for 3 professional references and an unofficial copy of your college transcripts. Incomplete application packets will not be considered. 
Application deadline is June 27, 2025, by 5pm. Applications will be reviewed on a rolling basis so apply early for consideration.
Click APPLY to job and fill out the form. Upload your Application Packet using the “Upload Resume” Link. 
Requirements
1. Master’s degree in Ecology, Botany, Wetland Ecology, Coastal Ecology, Natural Resource Management, Environmental Science, or a related biological/ecological field.
2. At least five years of relevant work experience post-graduate school.
3. Proven organizational skills and ability to independently prioritize, plan, lead and oversee multiple projects.
4. Experience in experimental design, field work (especially freshwater wetland and salt marsh field sampling in New England), data collection, quality control and data analysis (including statistics proficiency).
5. Working knowledge of community and ecosystem ecology; familiarity with plant and wildlife identification. 
6. Proven ability to effectively supervise, mentor, and develop team members, including providing feedback, setting performance goals, supporting professional growth, and fostering a positive, collaborative work environment.
7. Exceptional verbal and written communication skills, with the ability to convey complex information clearly and persuasively to diverse audiences, tailor messaging to different stakeholders, and produce high-quality reporting.
8. Collaboration experience and ability to work well in teams with others from a variety of experience levels to both efficiently execute projects and contribute to departmental strategic planning and oversight.
9. Proficiency with ArcGIS (ArcPro) and experience with interpreting and presenting geospatial research results, database management, map making, and the use of GPS units to collect data in the field.
10. Experience working with environmental monitoring loggers. 
11. Proficiency with Microsoft Office applications and data analysis software. 
12. Valid driver’s license required. 
Benefits
Salary commensurate with experience starting at $80,000, based on a 40-hour work week. Housing is provided in a shared, employee house at an adjusted rate -- salary is negotiable if housing is not needed. Work-related transportation is provided during working hours. Eligible to participate in the Foundation's full-time employee benefit plans and programs (subject to required waiting periods) including group health insurance, group life and accidental death insurance, disability insurance, dental insurance, 401K Plan, paid employee vacation and sick time, and paid holidays.

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