Associate Director, Antisense Oligonucleotide Analytical Development
About The Position
The Associate Director, Antisense Oligonucleotide (ASO) Analytical Development provides scientific and people leadership for analytical development activities supporting ASO drug substance and drug product programs. The role leads analytical method and control strategy development, oversees cross-functional execution, and contributes to regulatory filings. It establishes priorities, timelines, budgets, and resource plans in partnership with CMC functions and external organizations. The Associate Director also builds team capability, fosters innovation and automation, and supports portfolio and career-development goals. The ASO Analytical Development team develops analytical methods, control strategies, and supporting data packages for ASO drug substances and drug products. It 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.
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 an M.S. in a relevant scientific discipline with 8 or more years; or a B.S. in a relevant scientific discipline with 10 or more years.
- 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 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 insurance
- Dental insurance
- Vision insurance
- Life insurance
- Fitness and wellness programs, including fitness reimbursement
- Short- and long-term disability insurance
- At least 15 days of paid vacation and additional end-of-year shutdown time off (December 26–31)
- Up to 12 company-paid holidays and 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid maternity and parental leave
- 401(k) program with company-matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
- Short-term and long-term incentives, including cash bonus and equity incentive opportunities
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What This Job Offers
Job Type
Full-time
Career Level
Director
