Sr Scientist, Biomarker Bioanalytical Sciences

Biogen; Cambridge (MA); On-site; USD 122,000 - 163,000; Full time

Job summary

Biogen, based in Cambridge, MA, seeks a Senior Scientist to lead PK, biomarker, and immunogenicity assays across clinical programs. You will oversee CROs, develop strategies aligned with FDA/EMA/ICH, and contribute to regulatory submissions.

Strong emphasis on data interpretation and cross-functional collaboration with Clinical Development and Regulatory Affairs. The role requires hands-on assay development across platforms such as ELISA and MSD, with a focus on assay validation and regulatory

Qualifications

• PhD with 4+ years of industry experience in bioanalysis.
• Hands-on PK, biomarker, ADA/NAb assay development experience.
• Experience overseeing CROs and regulatory submissions.

Responsibilities

• Lead development, optimization, and validation of PK, biomarker, ADA, NAb assays.
• Develop immunogenicity strategy aligned with modality and clinical stage.
• Oversee CROs with scientific direction and data review.
• Collaborate with Clinical Development, Translational Medicine, Safety, and Regulatory.
• Prepare regulatory responses and support health authority interactions.
• Lead study/ program teams and contribute to manuscripts and presentations.

Skills

PK/Immunogenicity bioanalysis

Bioanalytical assay development

Regulatory submissions

CRO management

Data interpretation

Scientific writing

Cross-functional collaboration

Education

PhD in Immunology / related field

MS in related field

BS in related field

Tools

ELISA

MSD

Simoa

Cell-based assays

PK/PD platforms

Job description

About This RoleThe 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 DoLead 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 AreYou are a scientifically rigorous bioanalytical expert who develops and oversees PK, immunogenicity, and biomarker assays that support clinical programs and regulatory objectives. You excel at driving high-quality bioanalysis, interpreting complex data, collaborating across teams and CROs, and providing sound scientific and strategic guidance in a fast-paced environment.This position is based in Cambridge, MA and requires regular onsite presence; candidates must be within commuting distance or willing to relocate.Required Skills· PhD (preferred), MS, or BS in Immunology, Cellular and Molecular Biology, or a related scientific field.· PhD with 4+ years of relevant industry experience· 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.Preferred Skills· Experience authoring regulatory filing documents.· Industry experience in biotech/pharma, ideally in drug discovery or translational research.· Advanced technical expertise in method development and validation in a regulatory environmentJob Level: ManagementAdditional InformationThe base compensation range for this role is: $122,000.00-$163,250.00Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being ; including, but not limited to:Medical, Dental, Vision, & Life insurancesFitness & Wellness programs including a fitness reimbursementShort- and Long-Term Disability insuranceA 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 Significance80 hours of sick time per calendar yearPaid Maternity and Parental Leave benefit401(k) program participation with company matched contributionsEmployee stock purchase planTuition reimbursement of up to $10,000 per calendar yearEmployee Resource Groups participationWhy Biogen?We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.