Associate Director, Analytical Development
$180,000–$210,000 year
On-siteWaltham, Massachusetts, United States
Job Summary
Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, methods, and other CMC technical documentation for the development and commercial portfolio. Review analytical data packages supporting release testing, stability studies, drug substance, intermediates, and drug product manufacturing activities. Partner with Regulatory CMC, Quality, and external CDMOs to ensure timely delivery of accurate, phase-appropriate analytical documentation aligned with program objectives. Support analytical method development, validation, qualification, transfer, and lifecycle management while authoring and managing technical documents including validation protocols, specifications, and regulatory submission filings. Participate in analytical investigations related to deviations, OOS, and OOT events to ensure documentation meets quality and regulatory expectations. Drive continuous improvement initiatives focused on analytical reporting processes, data integrity, and operational efficiency.
Required Qualifications
- PhD in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline
- 8+ years of relevant industry experience
- Master's degree
- 10+ years of experience
- Bachelor's degree
- 12+ years of experience
- Experience in analytical development
- Experience in analytical reporting
- Experience in CMC technical writing
- Experience in related pharmaceutical development functions
- Strong understanding of small molecule analytical development
- Strong understanding of method validation
- Strong understanding of method transfer
- Strong understanding of stability testing
- Strong understanding of specifications
- Strong understanding of control strategies
- Demonstrated experience authoring, reviewing, and approving technical documents
- Experience authoring analytical methods
- Experience reviewing analytical methods
- Experience approving analytical methods
- Experience authoring protocols
- Experience reviewing protocols
- Experience approving protocols
- Experience authoring reports
- Experience reviewing reports
- Experience approving reports
- Experience authoring regulatory-supporting documentation
- Experience reviewing regulatory-supporting documentation
- Experience approving regulatory-supporting documentation
- Experience reviewing analytical data generated by CDMOs
- Experience reviewing analytical data generated by CROs
- Experience reviewing analytical data generated by external testing laboratories
- Working knowledge of HPLC/UPLC
- Working knowledge of GC
- Working knowledge of dissolution
- Working knowledge of spectroscopy
- Working knowledge of mass spectrometry
- Working knowledge of wet chemistry
- Working knowledge of particle size analysis
- Working knowledge of related pharmaceutical characterization methods
- Familiarity with ICH
- Familiarity with FDA
- Familiarity with EMA
- Familiarity with other global regulatory requirements related to analytical development
- Familiarity with other global regulatory requirements related to CMC documentation
- Strong scientific writing skills
- Strong data interpretation skills
- Strong problem-solving skills
- Strong project management skills
- Excellent verbal communication skills
- Excellent written communication skills
- Ability to effectively communicate complex technical information to diverse audiences
- Proven ability to work effectively within a cross-functional matrix organization
- Ability to build strong relationships with internal stakeholders
- Ability to build strong relationships with external partners
- Highly organized
- Ability to manage multiple priorities
- Ability to operate in a fast-paced biotech environment
Desired Qualifications
- Experience supporting late-stage development
- Experience supporting commercial programs
- Experience contributing to IND
- Experience contributing to NDA
- Experience contributing to MAA
- Experience contributing to other global regulatory submissions
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