Associate Director, Antisense Oligonucleotide Analytical Development

Biogen • Cambridge, MA

1d • $159,000 - $219,000

About The Position

The Associate Director, Antisense Oligonucleotide (ASO) Analytical Development will provide scientific and people leadership for analytical development activities supporting ASO drug substance and drug product programs. This role leads the development of analytical methods and control strategies, oversees cross-functional execution, and contributes to regulatory filings. The position establishes priorities, timelines, budgets, and resource plans while partnering across CMC functions and with external organizations. The Associate Director will also build team capability, foster innovation and automation, and support portfolio and career-development goals.

Requirements

• Ph.D. in analytical chemistry, pharmaceutical sciences, chemistry, biochemistry, chemical engineering, or a related scientific discipline with 6 or more years of relevant analytical development experience; or M.S. in a relevant scientific discipline with 8 or more years of relevant analytical development experience; or B.S. in a relevant scientific discipline with 10 or more years of relevant analytical development experience.
• Demonstrated experience in antisense oligonucleotide analytical development for drug substances and/or drug products, including analytical method development, validation, transfer, stability, characterization, comparability, and specification setting.
• Working knowledge of regulatory expectations and quality standards applicable to analytical development and CMC submissions, including relevant ICH guidance and GMP principles.
• Experience leading analytical workstreams, cross-functional CMC teams, and external partner activities in a matrixed environment.
• Experience managing, mentoring, and developing scientific staff.
• Strong written and verbal communication skills, including the ability to communicate complex scientific information clearly to technical and non-technical audiences.

Nice To Haves

• Experience supporting ASO programs across multiple stages of development, including GMP manufacture, regulatory submission, late-stage development, or commercialization.
• Expertise in analytical control strategies, comparability assessment, impurity and degradation characterization, product characterization, and advanced analytical technologies relevant to oligonucleotides.
• Experience managing CRO, CDMO, and QC laboratory relationships and resolving complex technical issues across internal and external laboratories.
• Experience contributing to regulatory filings, line reviews, briefing packages, or responses to health authority questions.
• Experience with analytical automation, digital workflows, electronic laboratory systems, data analytics, or emerging technologies that improve productivity and method robustness.
• Scientific leadership demonstrated through publications, conference presentations, professional society engagement, consortia participation, or external technical working groups.

Responsibilities

• Lead day-to-day analytical development activities for ASO drug substance and drug product programs, aligning project requirements with portfolio priorities for development and GMP support.
• Develop and implement phase-appropriate analytical methods and control strategies for the release, stability, characterization, and comparability assessment of ASO materials and products.
• Provide technical leadership for analytical strategy, method development, qualification, validation, transfer, specification setting, and lifecycle management.
• Represent Analytical Development on cross-functional CMC and asset teams, contributing to program strategy, risk assessment, planning, timelines, and decision-making.
• Author, review, and approve analytical content for regulatory submissions, technical reports, briefing packages, and responses to health authority questions.
• Collaborate with process development, Quality Control, Manufacturing Sciences, Regulatory CMC, portfolio management, and asset leadership to align analytical plans with process understanding and program needs.
• Oversee outsourced analytical work performed by contract research, development, manufacturing, and testing organizations, including review of protocols, data, reports, timelines, and technical issues.
• Manage, mentor, and develop scientists and associates, fostering inclusive teamwork, accountability, innovation, and achievement of portfolio and career-development goals.
• Develop the strategic roadmap for ASO Analytical Development, including capability building, hiring, capital investment, external services, automation, and budget planning.
• Represent the function in external consortia, technical working groups, publications, and scientific conferences to advance analytical science and help shape relevant industry and regulatory practices.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager