Head of Drug Product Analytical Operations
$214,000–$249,795 year
Hybrid · Boston, Massachusetts, United States
Job Summary
Head of Drug Product Analytical Operations leads analytical development and lifecycle support for drug products, peptide-based products, medical devices, and combination products within CMC activities. Provides strategic and technical leadership across Technical Operations, Quality, Regulatory CMC, and external partners to support development, technical transfers, process validation, regulatory submissions, clinical bulk supply readiness, commercial preparedness, and lifecycle management. Oversees outsourced analytical programs, drives risk-based decisions, ensures regulatory compliance, and leads teams to foster collaboration and operational excellence. Responsible for leadership and development of the Analytical Drug Product team; oversight of CRO/CDMO activities; development of analytical strategy for drug products, devices, and combination products including methods, stability, extractables and leachables; management of impurity, degradation, release, stability, comparability, and compatibility assessments; collaboration with CMC and product teams for development, regulatory submissions, clinical bulk supply including release and stability; ensuring stability programs meet global expectations; regulatory support including health authority interactions and responses to inspections; oversight of primary and secondary packaging analytical evaluations; cross-functional collaboration; budget and resource management; project management across analytical activities; staying current on analytical, packaging, and regulatory topics; driving continuous improvement and external innovation.
Required Qualifications
- PhD in Analytical Chemistry, Pharmaceutical Sciences, Chemistry, or related discipline with 10+ years of pharma/biotech industry experience; or Master’s degree with 15+ years of relevant industry experience
- Extensive analytical development experience with drug products, devices, and packaging including lifecycle development, Phase 3, process validation, launch readiness, and commercial transfer
- Experience supporting injectable synthetic peptide drug products, including characterization, orthogonal methods, bioassays, solid-state characterization, stability, and phase-appropriate analytical strategies
- Proven success managing outsourced analytical activities with global CROs/CDMOs across complex development programs
- Experience with method development, qualification, validation, transfer, comparability, and regulatory submissions for drug products, devices, and combination products
- Experience with packaging assessments including extractables and leachables, compatibility evaluations, and related analytical studies
- Familiarity with ICH, FDA, EMA, JP, and ISO standards; experience supporting health authority interactions and phase-appropriate development
- Strong project management and organizational skills; ability to manage complex initiatives in a matrix environment
- Strong problem-solving skills in troubleshooting analytical challenges for drug products, devices, and packaging
- Effective communication and collaboration skills; ability to influence cross-functional teams and external partners
- Proficiency in data analysis and interpretation; translating findings into technical, regulatory, and business recommendations
- Equal Opportunity Employer statement and base salary range information
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