Job Description
Title: Analytical Development Scientist - Biologics
Location: Andover, MA 01810
100% Onsite
Duration: 12 Months contract
Position Summary
This role provides a combination of analytical laboratory testing and non-laboratory support to the QC Product Technical Support department in support of product lifecycle management. The scope includes analysis of biological products as well as authoring documentation to support lifecycle activities.
Responsibilities include analytical method optimization, method validation, comparability assessments, and the evaluation of new technologies.
The role requires a solid understanding of scientific principles underlying test methods, method validation requirements, data analysis, and cGMP requirements.
Core Responsibilities
- Provide technical support for new or established analytical methods, troubleshooting methods and method improvements.
- Analyze and interpret results with a solid scientific understanding, ensuring accuracy, completeness, and compliance.
- Author test methods, validation protocols and reports, as well as supporting technical documentation for product lifecycle management.
- Identify technical issues, method performance issues, instrument malfunctions and methodology problems and participate in necessary investigations.
- Maintain all related data and records in compliance with cGMPs and quality procedures.
- Track timelines and deliverables, and communicate effectively across teams to ensure alignment and timely execution.
Basic Qualifications
Education
- B.S. in Chemistry, Biology or related scientific discipline with a minimum of 5 years of applicable laboratory experience
- OR
- M.S. with a minimum of 3 years of relevant experience
Technical Knowledge & Experience
- Knowledge and practical application of relevant analytical techniques
- Experience within the biopharmaceutical industry, including knowledge and experience relevant to biopharmaceutical unity operations and/or laboratory operations
- Experience in method troubleshooting and laboratory investigations
- Experience in validation of analytical methods
- Experience with cGMPs and regulatory guidance
Analytical Techniques
- HPLC
- CE
- Gel
- Spectroscopy