About This Role 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.
Who We Are The ASO Analytical Development team develops analytical methods, control strategies, and supporting data packages for ASO drug substances and drug products. The team partners with process development, Quality Control, Manufacturing Sciences, Regulatory CMC, asset teams, and external laboratories to support development programs, GMP activities, and regulatory submissions. The team emphasizes scientific rigor, innovation, collaboration, operational excellence, and talent development.
What You'll Do - 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.
Who You Are You have a proven track record in ASO analytical development for drug substances and/or drug products, along with strong scientific judgment and people leadership. You have current knowledge of analytical control strategies, comparability assessments, product development, and regulatory expectations. You are a clear communicator and possess the ability to effectively collaborate across scientific, quality, regulatory, manufacturing, and external partner organizations.
Required Qualifications- 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.
Preferred Qualifications - 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.
Job Level: Management
Additional InformationThe base compensation range for this role is: $159,000.00-$219,000.00
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.
