Biogen
Associate Director, Small Molecule Analytical Development
Cambridge, MA, USA · Director
Sponsorship not specified$159k-$219kDetected 1 day ago
Data VisualizationGMPResearchMass SpectrometryLeadershipCommunicationCollaborationMentoringPublic 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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About the role
- This role is responsible for developing phase-appropriate analytical strategies, overseeing method development and validation, supporting impurity control and specification setting, and contributing to CMC regulatory submissions.
- The position works closely with cross-functional partners and external organizations to support reliable clinical supply, regulatory readiness, and commercialization objectives.
- The Associate Director, Small Molecule Analytical Development will provide scientific and people leadership for analytical development activities supporting small molecule programs from early clinical development through late-stage registration and commercialization.
Responsibilities
- Lead analytical development activities for small molecule drug substance and drug product programs, including method development, qualification, validation, transfer, lifecycle management, and routine control strategy support.
- Develop and implement phase-appropriate analytical control strategies for identity, assay, impurities, degradation products, residual solvents, elemental impurities, solid-state attributes, dissolution, and other critical quality attributes.
- Collaborate with Process Chemistry, Chemical Engineering, Solid Form, Formulation, Quality, Regulatory CMC, Manufacturing, and Clinical Supply to align analytical methods and specifications with process understanding, product performance, and program needs.
- Manage, mentor, and develop scientists, supporting performance, career development, inclusive teamwork, and a culture of accountability and continuous improvement.
- Evaluate and implement analytical technologies, digital tools, automation, and data approaches that improve productivity, method robustness, compliance, and decision-making.
- The successful candidate will have experience leading analytical development activities in a pharmaceutical or biotechnology setting and will be able to apply technical expertise, sound judgment, and collaborative leadership to support development programs.
- The candidate should be able to communicate clearly with scientific, regulatory, quality, manufacturing, and external partner stakeholders and contribute effectively in a matrixed environment.
Requirements
- M.S. in a relevant scientific discipline with 8 or more years of relevant experience in pharmaceutical or biotechnology development
- B.S. in a relevant scientific discipline with 10 or more years of relevant experience in pharmaceutical or biotechnology development.
- Experience in small molecule analytical development, including chromatographic and/or spectroscopic method development, validation, transfer, impurity profiling, stability, 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, project teams, or cross-functional CMC activities in a matrixed environment.
- Strong written and verbal communication skills, including the ability to communicate scientific information clearly to technical and non-technical audiences.
Nice to have
- Experience supporting small molecule programs from early development through late-stage registration, launch, or post-approval lifecycle management.
- Experience with impurity identification and control, degradation pathway assessment, mass spectrometry, NMR, solid-state characterization, dissolution, or drug product analytical development.
- Experience with digital analytical workflows, automation, electronic laboratory systems, modeling, data visualization, or emerging analytical technologies.
- Scientific contributions through publications, presentations, professional society engagement, consortia participation, or other external scientific activities.
- Job Level: Management
- Additional Information
- The base compensation range for this role is: $159,000.00-$219,000.00
- including, but not limited to:
Compensation
- Tuition reimbursement of up to $10,000 per calendar year
Benefits
- Medical, Dental, Vision, & Life insurances
- Paid Maternity and Parental Leave benefit
- 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 Small Molecule Analytical Development team develops analytical methods, control strategies, and supporting data packages for small molecule therapeutics.
- The team partners with process chemistry, chemical engineering, solid form, formulation, quality, regulatory CMC, manufacturing, clinical supply, and external development partners to support development programs and regulatory submissions.
- The team emphasizes scientific rigor, collaboration, data-driven decision-making, operational excellence, and continuous improvement.
- 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.
This listing is sourced directly from Biogen's careers page and normalized into a canonical job model.