Senior Scientist, Bioanalytical Sciences
About The Position
About This Role The Biomarkers and Systems Biology group is seeking a highly motivated Senior Scientist to join a dynamic team responsible for developing and executing bioanalytical strategies across multiple therapeutic programs. This role is central to the development, optimization, and validation of bioanalytical assays supporting early and late‑stage clinical studies. The Senior Scientist will lead immunogenicity strategy, provide scientific oversight of CRO‑executed assays, and contribute to global regulatory submissions. The ideal candidate has deep expertise in pharmacokinetic and immunogenicity bioanalysis, with additional experience in biomarker methods. Hands‑on assay development experience across multiple platforms and a strong understanding of regulatory expectations are essential. The role requires scientific rigor, sound judgment, and the ability to operate effectively in a fast‑paced biotech environment. What You’ll Do Lead development, optimization, and validation of PK, biomarker, ADA, NAb, and other immunogenicity‑related assays in alignment with FDA, EMA, and ICH guidelines. Develop and execute immunogenicity strategy, including risk assessments aligned with modality, target biology, and clinical stage. Oversee outsourced biomarker, immunogenicity, and bioanalytical assays at CROs, providing scientific direction, troubleshooting, protocol guidance, and data review. Analyze and interpret PK, PD, safety, biomarker, and immunogenicity data in close collaboration with Clinical Development, Clinical Pharmacology, Translational Medicine, Safety, and Regulatory Affairs. Ensure data integrity, traceability, and scientific clarity across all bioanalytical and regulatory deliverables. Evaluate, implement, and provide expertise across analytical platforms (e.g., ELISA, MSD, etc.). Prepare regulatory responses, briefing packages, and support interactions with health authorities. Serve as the Bioanalytical Lead on study and program teams, defining strategy and ensuring alignment with development objectives. Deliver scientific presentations internally and externally and contribute to manuscripts and publications. Promote best practices in assay development, CRO oversight, and scientific rigor. Who You Are You are a scientifically rigorous bioanalytical expert who thrives on developing, validating, and troubleshooting complex PK, immunogenicity, and biomarker assays to support clinical programs. You are motivated by driving high‑quality, clinically relevant bioanalysis and immunogenicity strategy, and you excel at interpreting data in a cross‑functional, fast-paced environment. You enjoy partnering with internal teams and CROs, providing clear scientific direction, and ensuring assays meet regulatory and program needs. You communicate clearly, work independently, and bring strong judgment to problem‑solving, regulatory interactions, and strategic decision-making. This position is based in Cambridge, MA and requires regular onsite presence; candidates must be within commuting distance or willing to relocate.
Requirements
- MS, or BS in Immunology, Cellular and Molecular Biology, or a related scientific field. MS with 6+ years BS with 10+ years
- Hands‑on expertise with ligand‑binding assays (ELISA, MSD, Simoa), cell‑based assays, PK/PD biomarker methods, and ADA/NAb assay development.
- Experience supporting clinical trial sample analysis and data review.
- Strong understanding of global regulatory expectations (FDA, EMA, ICH, MHRA) for bioanalytical and immunogenicity submissions.
- Proven experience managing CROs and external scientific partnerships.
- Excellent technical writing, analytical interpretation, and communication skills.
- Ability to work independently and effectively influence cross‑functional teams in a matrixed environment.
- Strong verbal and written communication skills with the ability to tailor presentations to diverse audiences.
- Highly flexible, results‑oriented, and comfortable operating in a fast‑paced, dynamic environment.
- Proficiency with ligand‑binding and cell‑based assay technologies across multiple platforms.
Nice To Haves
- PhD in Immunology, Cellular and Molecular Biology, or a related scientific field with 4+ years of relevant industry experience.
- Industry experience in biotech/pharma, ideally in drug discovery or translational research.
- Advanced technical expertise in method development and validation in a regulatory environment
- Experience authoring regulatory filing documents is a plus.
Responsibilities
- Lead development, optimization, and validation of PK, biomarker, ADA, NAb, and other immunogenicity‑related assays in alignment with FDA, EMA, and ICH guidelines.
- Develop and execute immunogenicity strategy, including risk assessments aligned with modality, target biology, and clinical stage.
- Oversee outsourced biomarker, immunogenicity, and bioanalytical assays at CROs, providing scientific direction, troubleshooting, protocol guidance, and data review.
- Analyze and interpret PK, PD, safety, biomarker, and immunogenicity data in close collaboration with Clinical Development, Clinical Pharmacology, Translational Medicine, Safety, and Regulatory Affairs.
- Ensure data integrity, traceability, and scientific clarity across all bioanalytical and regulatory deliverables.
- Evaluate, implement, and provide expertise across analytical platforms (e.g., ELISA, MSD, etc.).
- Prepare regulatory responses, briefing packages, and support interactions with health authorities.
- Serve as the Bioanalytical Lead on study and program teams, defining strategy and ensuring alignment with development objectives.
- Deliver scientific presentations internally and externally and contribute to manuscripts and publications.
- Promote best practices in assay development, CRO oversight, and scientific rigor.
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
