Sr Scientist, Biomarker Bioanalytical Sciences
About The Position
The Biomarkers and Systems Biology group seeks a highly motivated Senior Scientist to develop and execute bioanalytical strategies across multiple therapeutic programs. The role is central to developing, optimizing, and validating bioanalytical assays supporting early- and late-stage clinical studies. The Senior Scientist leads immunogenicity strategy, provides scientific oversight of CRO-executed assays, and contributes to global regulatory submissions. The position calls for deep expertise in pharmacokinetic and immunogenicity bioanalysis, additional experience with biomarker methods, hands-on assay development across multiple platforms, and a strong understanding of regulatory expectations. The role requires scientific rigor, sound judgment, and effectiveness in a fast-paced biotech environment. The position is based in Cambridge, Massachusetts, with regular onsite presence; candidates must be within commuting distance or willing to relocate.
Requirements
- PhD, MS, or BS in Immunology, Cellular and Molecular Biology, or a related scientific field; PhD is preferred.
- PhD with 4+ years of relevant industry experience, MS with 6+ years, or 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, including tailoring 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.
- Must be within commuting distance of Cambridge, MA, or willing to relocate; position requires regular onsite presence.
Nice To Haves
- Experience authoring regulatory filing documents.
- Industry experience in biotech or pharma, ideally in drug discovery or translational research.
- Advanced technical expertise in method development and validation in a regulatory environment.
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 by providing scientific direction, troubleshooting, protocol guidance, and data review.
- Analyze and interpret PK, PD, safety, biomarker, and immunogenicity data with Clinical Development, Clinical Pharmacology, Translational Medicine, Safety, and Regulatory Affairs.
- Ensure data integrity, traceability, and scientific clarity across bioanalytical and regulatory deliverables.
- Evaluate, implement, and provide expertise across analytical platforms such as ELISA and MSD.
- Prepare regulatory responses and briefing packages, and support interactions with health authorities.
- Serve as 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, and life insurance.
- Fitness and wellness programs, including fitness reimbursement.
- Short- and long-term disability insurance.
- A minimum of 15 days of paid vacation and additional end-of-year shutdown time off from December 26 through December 31.
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance.
- 80 hours of sick time per calendar year.
- Paid maternity and parental leave benefit.
- 401(k) program with company-matched contributions.
- Employee stock purchase plan.
- Tuition reimbursement of up to $10,000 per calendar year.
- Employee Resource Groups participation.
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
