Head of Drug Product Analytical Operations
Ironwood Pharmaceuticals
5 days ago
Remote friendly (Boston, MA)
United States
Operations
Essential Functions
- Lead and develop the Analytical Drug Product team.
- Oversee outsourced analytical development at CROs/CDMOs (phase-appropriate strategy, quality, governance, alignment).
- Build external partnerships; review technical documents; manage escalation and lifecycle changes.
- Lead analytical strategy for drug products, medical devices, and combination products (methods, characterization, stability, extractables/leachables; peptide-specific support).
- Oversee impurity, degradation, release, stability, comparability, and compatibility assessments.
- Partner with CMC/product teams for development, global regulatory submissions, clinical bulk supply release/stability, and lifecycle plans; ensure stability programs meet global expectations.
- Prepare/review analytical content for global regulatory submissions; serve as analytical lead for health authority interactions; lead responses to agency questions, inspections, and audits.
- Oversee analytical evaluation of primary/secondary packaging (integrity, E&L, compatibility) and integrate packaging studies into stability/lifecycle.
- Lead cross-functional governance/technical transfer/issue resolution and risk-based decisions across internal and external sites.
- Manage analytical budgets and external spending/cost optimization.
- Lead multiple analytical activities; prioritize, mitigate risks, troubleshoot/investigate, and communicate recommendations.
Requirements
- Ph.D. (Analytical Chemistry/Pharmaceutical Sciences/Chemistry or related) with 10+ years pharma/biotech experience OR Master’s with 15+ years.
- Extensive experience with combination products (injectable support; packaging; lifecycle; Phase 3; process validation; launch readiness; commercial transfer).
- Experience with injectable synthetic peptide characterization (orthogonal methods, bioassays, solid-state, stability; phase-appropriate strategies).
- Proven management of outsourced analytical programs with global CROs/CDMOs.
- Deep knowledge of method development/qualification/validation/transfer, comparability, and regulatory submissions for drug products/devices/combination products.
- Packaging assessment expertise (E&L, compatibility).
- Familiarity with ICH, FDA, EMA, JP, and relevant ISO standards.
Skills
- Strong project management/organization; problem-solving; communication/collaboration; data analysis and translating findings into technical/regulatory/business recommendations.
Benefits (as stated)
- Eligible for Restricted Stock Units; bonus or sales incentive; company-sponsored 401(k) match; medical/dental/vision/prescription coverage; wellness stipends; generous vacation/holiday schedule.
- Lead and develop the Analytical Drug Product team.
- Oversee outsourced analytical development at CROs/CDMOs (phase-appropriate strategy, quality, governance, alignment).
- Build external partnerships; review technical documents; manage escalation and lifecycle changes.
- Lead analytical strategy for drug products, medical devices, and combination products (methods, characterization, stability, extractables/leachables; peptide-specific support).
- Oversee impurity, degradation, release, stability, comparability, and compatibility assessments.
- Partner with CMC/product teams for development, global regulatory submissions, clinical bulk supply release/stability, and lifecycle plans; ensure stability programs meet global expectations.
- Prepare/review analytical content for global regulatory submissions; serve as analytical lead for health authority interactions; lead responses to agency questions, inspections, and audits.
- Oversee analytical evaluation of primary/secondary packaging (integrity, E&L, compatibility) and integrate packaging studies into stability/lifecycle.
- Lead cross-functional governance/technical transfer/issue resolution and risk-based decisions across internal and external sites.
- Manage analytical budgets and external spending/cost optimization.
- Lead multiple analytical activities; prioritize, mitigate risks, troubleshoot/investigate, and communicate recommendations.
Requirements
- Ph.D. (Analytical Chemistry/Pharmaceutical Sciences/Chemistry or related) with 10+ years pharma/biotech experience OR Master’s with 15+ years.
- Extensive experience with combination products (injectable support; packaging; lifecycle; Phase 3; process validation; launch readiness; commercial transfer).
- Experience with injectable synthetic peptide characterization (orthogonal methods, bioassays, solid-state, stability; phase-appropriate strategies).
- Proven management of outsourced analytical programs with global CROs/CDMOs.
- Deep knowledge of method development/qualification/validation/transfer, comparability, and regulatory submissions for drug products/devices/combination products.
- Packaging assessment expertise (E&L, compatibility).
- Familiarity with ICH, FDA, EMA, JP, and relevant ISO standards.
Skills
- Strong project management/organization; problem-solving; communication/collaboration; data analysis and translating findings into technical/regulatory/business recommendations.
Benefits (as stated)
- Eligible for Restricted Stock Units; bonus or sales incentive; company-sponsored 401(k) match; medical/dental/vision/prescription coverage; wellness stipends; generous vacation/holiday schedule.