Biogen

Biogen

Associate Director, Antisense Oligonucleotide Analytical Development

Cambridge, MA, USA · Director

Sponsorship not specified$159k-$219kDetected 1 day ago
Data AnalysisGMPResearchLeadershipCommunicationCollaborationMentoringPublic Speaking

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odds of building a lasting career here

59Sponsors, lottery-bound
Cap-exempt (no lottery)0
Sponsors this role82
Entry-level history0
PERM / green-card track0
Lottery odds (Level IV)94
Fits your clock70

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Green-card filing pattern in this occupation

Context, not a finding about this posting: of this employer's 7 green-card filings in this occupation, 100% were for a worker who already held the job.

Files H-1B transfers

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About the 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.
  • The position establishes priorities, timelines, budgets, and resource plans while partnering across CMC functions and with external organizations.

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.
  • 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.
  • 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.

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
  • M.S. in a relevant scientific discipline with 8 or more years of relevant analytical development experience
  • B.S. in a relevant scientific discipline with 10 or more years of relevant analytical development experience.
  • Working knowledge of regulatory expectations and quality standards applicable to analytical development and CMC submissions, including relevant ICH guidance and GMP principles.
  • Strong written and verbal communication skills, including the ability to communicate complex scientific information clearly to technical and non-technical audiences.
  • 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.

Nice to have

  • 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 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

Compensation

  • Tuition reimbursement of up to $10,000 per calendar year

Benefits

  • Medical, Dental, Vision, & Life insurances
  • Paid Maternity and Parental Leave benefit
  • Author, review, and approve analytical content for regulatory submissions, technical reports, briefing packages, and responses to health authority questions.
  • 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)
  • Employee stock purchase plan
  • 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.

Company info

  • 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.
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 401(k) program participation with company matched contributions
  • 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.
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