Principal Scientist, Biomarker Bioanalytical Sciences

Mygwork; Massachusetts; In loco; USD 141.000 - 188.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical, Dental, Vision

Performance bonus

Equity plan

Descrizione del lavoro

Biogen in the United States is seeking a Principal Scientist to lead bioanalytical strategy, assay development, validation, and CRO oversight to underpin discovery through regulatory submissions. The role partners across teams to ensure high-quality data that informs critical development decisions and regulatory filings.

You will oversee biomarker and PD/PK assays, drive method development on multiple platforms, and guide data interpretation while maintaining regulatory readiness and scientific

Competenze

• PhD with 5+ years of industry experience in bioanalysis or biomarker sciences.
• MS with 8+ years of industry experience in bioanalytical settings.
• Experience developing and implementing biomarker and bioanalytical assays.

Mansioni

• Serve as the bioanalytical lead on programs, guiding assay strategies and data interpretation.
• Develop and validate bioanalytical assays (PK, ADA) and support biomarker methods.
• Lead design and execution of assay development and regulatory-facing data packages.
• Provide scientific oversight of CROs and external labs, including vendor management.
• Review validation reports and data to ensure regulatory compliance and quality.
• Investigate assay issues and recommend corrective actions.
• Develop, transfer, and validate bioanalytical and biomarker assays across platforms.
• Evaluate novel biomarker technologies and their fit for use.
• Monitor assay performance, QC trends, and cross-study comparability.
• Interpret data and communicate risks and recommendations to teams.
• Contribute to IND, CTA, BLA submissions and regulatory documentation.
• Support audits/inspections through bioanalytical documentation and study records.

Conoscenze

Bioanalytical leadership

Assay development

Regulatory submissions

CRO oversight

Data interpretation

Scientific writing

Project collaboration

Formazione

PhD in Immunology/related field

MS in related field

Descrizione del lavoro

About This Role

The Biomarkers and Systems Biology group isseekinga highly motivated Principal Scientist to contribute to the development and implementation of biomarker and bioanalytical strategies supporting discovery, translational, and clinical-stage programs. The successful candidate will serve as a Bioanalytical Lead for assigned programs, providing scientific leadership for assay development, analytical validation,CRO oversightfor sample analysis anddata interpretation to support critical development decisions.This role will partner closely withvarious internal and external functionsto ensure the generationand interpretationof high-quality bioanalyticaland biomarkerdata supporting clinical developmentandregulatory submissions.

WhatYou'llDo

• Serve as the bioanalytical representative on assigned discovery and development programs, providing scientificexpertiseand contributing to biomarker and bioanalytical strategies aligned with programobjectives.

• Develop and execute fit-for-purpose bioanalytical approaches(PK, ADA) andsupport the implementation of Biomarker methods(TE, PD, Disease) supporting the biomarker strategy.

• Lead the design and execution of assay development,analyticalvalidation, and sample analysis plans that support program and regulatory needs.

• Provide scientific oversight of CROs and external laboratories, including assay development, validation, sample analysis, troubleshooting, data review, and vendor management.

• Review protocols, validation reports, sample analysis reports, and bioanalytical data packages to ensure scientific quality, regulatory compliance, and fitness-for-purpose.

• Support investigation of assay-related issues, deviations, and root cause analyses, providing scientific recommendations for corrective actions.

• Develop,optimize, transfer, andvalidatebioanalytical andbiomarker assayson various platformson existing andemerging analytical platforms.

• Evaluate and implement novel biomarker technologies, assessing platform performance and suitability based on context of use.

• Monitor assay performance, data quality, QC trends, robustness, and cross-study comparability throughout the assay lifecycle, ensuring data integrity and scientific rigor.

• Interpret bioanalytical data and communicate findings, risks, and recommendations to project teams and functional stakeholders.

• Contribute scientific content and data packages supporting IND, CTA, BLA, and other regulatory submissions.

• Support audits and inspections through preparation and review of bioanalytical documentation and study records.

• Contribute to scientific publications, conference presentations, and the advancement of best practices in biomarker sciences, bioanalysis, and CRO management

Who You Are

You are a scientifically rigorous bioanalytical expert who thrives ondeveloping, qualifying, and implementing biomarker, pharmacodynamic, translational, and target engagement assays supporting discovery through clinical development.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.

Required Skills

• PhDorMS in Immunology, Cellular and Molecular Biology, or a related scientific field.

• PhD with5+ years of relevant industry experience

• MS with8+ yearsof relevant industry experience

• Experience developing and implementing biomarker andbioanalyticalassays across discovery and clinical development settings.

• Advanced technicalexpertiseinmethod development and validation in a regulated environment

• Experience supporting sample analysis and data review.

• Familiarity with biomarker and bioanalytical requirements supporting regulatory filings and clinical development programs.

• Experience contributing bioanalytical content to IND, CTA, BLA, and other regulatory submissions.

• Experience providing scientific oversight of CROs and external laboratory partners.

• 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.

• Proficiencywith ligand‑binding and cell‑based assay technologies across multiple platforms.

• Industry experience in biomarker sciences, translational research, or bioanalytical sciences supporting drug development programs.

Preferredskills

• Experience supporting clinical biomarker programs.

• Strong publication and scientific communication record.

• Experience authoring and defending bioanalytical content for IND, CTA, BLA, MAA, and other global regulatory submissions.

Job Level: Management

Additional Information

The base compensation range for this role is: $141,000.00-$188,000.00

Base 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 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

Why 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. Read on to learn more about Biogen.

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.