Job Description
Soufflé Therapeutics is a biotech company focusing on the cell-type specific delivery of genetic medicines. It’s team of driven scientists is making a mark in delivery of oligonucleotides to extrahepatic tissues. We thrive in a purpose-building lab and office space in Watertown. Come and join us in our quest!
Overview
The Preclinical Development team at Souffle Therapeutics is seeking an experienced scientist for the role of a head of Bioanalysis, to support the advancement of innovative targeted genetic medicines from discovery through clinical development. This role will provide scientific, operational and strategic leadership for research grade and regulated bioanalysis activities. This includes the application of state-of-the-art analytical technology, in-house feasibility assessment, selection and oversight of external partnerships for the delivery of high-quality PK, PD, biomarker, and immunogenicity data to support global regulatory submissions and GxP analysis of preclinical and clinical samples.
This is an exciting opportunity for a proven bioanalytical scientist and leader to drive assay strategy, interface with scientific and project teams at CROs, mentor scientists, and contribute to the continued success of a pioneering platform for targeted and precise delivery of genetic medicines
Role Summary
This Bioanalysis Leader will strategically identify suitable PK and PD assays for Souffle’s development programs. If necessary, the incumbent will lead internal efforts to probe feasibility of assays to characterize PK, PD and efficacy of novel targeted antibody-oligonucleotide conjugates. The candidate for this role will collaborate with Souffle’s scientists or consultants in Discovery, preclinical and clinical development, quantitative Medicine (PK/PD M&S), toxicology, CMC and regulatory affairs to support multiple programs in our pipeline. Major focus of this role is to interface with external scientific contract labs in order to lead and manage outsourced bioanalytical activities. This individual will collaborate with external CRO partners to ensure assays are fit-for-purpose and compliant with global regulatory expectations. In this role, the successful candidate will serve as a subject matter expert in regulated bioanalysis (GLP, GCP or CLIA), providing strategic direction for assay development, validation, transfer, and lifecycle management.
Key Responsibilities
Scientific & Technical Leadership
- Align with Souffle’s strategy and develop a bioanalytical strategy for current and future preclinical development programs along with the sustained support through all phases of clinical development
- Lead the design, development, validation, and implementation of bioanalytical methods supporting PK, PD, biomarker, and immunogenicity endpoints.
- Provide deep expertise in protein and oligonucleotide quantitation approaches including ligand-binding assays, PCR-based methods, cell-based assays or mass spectrometry.
- Enable novel assays by application of advances in spatial multi-omics technologies
- Guide assay strategy across stages of development, ensuring phase-appropriate validation and regulatory alignment.
- Advise on method performance, troubleshoot technical challenges, and ensure scientific rigor in data interpretation.
CRO & Vendor Selection, Collaboration and Oversight
- Support selection and strategic management of external laboratory partners.
- Serve as the primary scientific interface for CRO bioanalytical activities.
- Oversee study plans, contracts, data transfer agreements, validation reports, and final study reports.
- Track and ensure timely delivery of high-quality data and compliance with GLP or GCP or CLIA standards.
Cross-Functional Collaboration
- Represent Bioanalysis on program teams to support study design, timeline execution, and regulatory strategy.
- Collaborate closely with discovery, translational, clinical, and regulatory teams to enable seamless assay transfer from discovery through development into clinical development.
- Collaborate with biostatisticians and Clinical Operations to design and support the setup and execution of bioanalytical assays for timely human safety and efficacy readouts
- Contribute to IND, CTA, NDA, and MAA regulatory submissions.
Team Leadership & Development
- Mentor and develop analytical scientists, fostering technical excellence and accountability.
- Promote best practices in critical reagent and assay lifecycle management.
- Drive strategic planning aligned with pipeline priorities, corporate goals and fiscal responsibility.
Qualifications
Education & Experience
- Ph.D. in Analytical Chemistry, Biochemistry, Molecular Biology ideal or related discipline with 10+ years of industry experience; or MS/BS with equivalent progressive experience.
- Demonstrated leadership experience managing scientists and/or CRO partners.
Technical Expertise
- Extensive hands-on experience with LBA, PCR, LC-MS/MS, and/or cell-based bioanalytical methods.
- Strong background in regulated bioanalysis (GLP, GCLP, CLIA).
- Experience supporting bioanalysis for nucleic acid therapeutics (siRNA, ASO, mRNA), biologics, or small molecules.
- Proven experience authoring and reviewing bioanalytical reports and regulatory documentation.
Core Competencies
- Deep understanding of drug development, preclinical and clinical bioanalytical strategy.
- Strong strategic thinking and problem-solving skills.
- Excellent communication and stakeholder management skills in a highly matrixed environment.
- Ability to manage multiple programs in parallel while maintaining high scientific standards.
At Soufflé Therapeutics, we are intentional about building an equitable culture. How we treat our people is reflective of this focus. We share the pay range for this specific role with the actual base salary reflected in criteria such as job-related knowledge, skills, market factors, and experience:
$232,000 - $295,000/year + Annual management bonus
We are an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.