Associate Director, Antisense Oligonucleotide Analytical Development

Associate Director, Antisense Oligonucleotide Analytical Development

Apply

remote type

On Campus

locations

Cambridge, MA

time type

Full time

posted on

Posted Today

job requisition id

REQ24385

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 Information

• The 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