Sr. Scientist, Bioanalytical Sciences

Job Description

Biogen’s West Coast Hub, based in South San Francisco, is specifically focused on transforming the lives of patients with severe immune-mediated diseases by developing novel targeted therapies with outsized clinical impact, faster. To accomplish this, we are seeking top talent to join us on our journey.

About This Role

The Sr. Scientist will be responsible for developing, optimizing, and validating biomarker and bioanalytical assays in clinical and nonclinical studies and will be responsible for managing external bioanalytical CROs. This position will report into the Bioanalytical Sciences and Operations West Coast Hub Lead.

What You’ll Do

• Serve as the technical lead for PK, ADA, and biomarker assay development and optimization efforts, providing hands-on expertise in MSD, Ella, ELISA, and other immunoassay platforms.
• Lead the transfer and validation of assays at CROs and clinical laboratories, ensuring compliance with GLP/GCLP and clinical study requirements.
• Function as the primary scientific and technical point of contact for external vendors,  overseeing assay transfers, work plans, timelines, data quality, and deliverables.
• Provide scientific oversight in method feasibility assessments and troubleshooting to drive high-quality data generation.
• Review and approve key bioanalytical and biomarker assay-related documents, including SOWs, validation reports, SOPs, SAPs, and DTAs.
• Collaborate with clinical biomarkers, clinical operations, clinical pharmacology, biometrics, and regulatory teams to ensure seamless integration of biomarker strategies into clinical studies.
• Monitor and interpret biomarker and bioanalytical data, providing scientific and technical insights to guide decision-making.
• Stay current with emerging biomarker technologies and regulatory guidelines to inform assay development strategies.

Who You Are

You are a scientifically driven, detail-oriented biomarker scientist with hands-on experience in bioanalytical and immunoassay development and validation. You thrive in a collaborative environment, enjoy solving complex problems, and have a track record of working effectively with vendors and CROs. You’re comfortable working with clinical samples and are passionate about generating high-quality data to support drug development.

Qualifications

Required Skills:

• MS with 4+ years of experience or BS with 6+ years of experience in bioanalytical and/or biomarker assay development and execution in clinical trials.
• Strong laboratory background with proficiency in several biological techniques (ELISA, ECL, etc.) and their associated software.
• Experience with immunoassay platforms such as ELISA (SpectraMax), MSD (Meso Scale Discovery), and ELLA (Protein Simple).
• Extensive experience in technical development, validation, and implementation bioanalytical (PK and ADA) and biomarker assays for clinical studies.
• Strong scientific problem-solving and data interpretation skills.
• Excellent organization, written and verbal communication skills.
• Project management skills to meet critical timelines associated with various activities necessary to support the assessment of clinical samples

Preferred Skills

• PhD with 2+ years of experience 
• Experience working with external partners such as CROs and vendors to support outsourced activities.
• Additional expertise in platforms like Simoa (Quanterix), Singulex (Erenna), Olink, and Somalogic is a plus.

Additional Information

The base compensation range for this role is $119,000-160,000. Base salary offered is determined though 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 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 days off for Personal Significanc