Director of Drug Product Development

DirectorDirectorFull TimeRemoteLeadTeam 11-50H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

98 days ago

Salary

Not specified

Seniority

Lead

Bachelor Degree15 yrs expEnglish

Job Description

• Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management. • Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs. • Provide scientific oversight of formulation development, device compatibility, and container–closure system. • Partner with other functional area leads to ensure successful method validation, product specifications, and stability studies to support regulatory filings. • Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness. • Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions. • Manage technology transfer when needed, manufacturing documentation, and process validation protocols/reports. • Collaborate closely with other functional areas (drug substance, analytical development, and QA) to ensure a robust control strategy. • Provide technical guidance and mentoring to junior staff or matrixed contributors as needed.

Job Requirements

  • 15+ years of experience in inhalation product development (preferably dry powder inhalation).
  • Demonstrated success advancing an inhalation product through late-stage development (Phase 2b/3) and into registration.
  • Hands-on experience with formulation, process scale-up, drug-device compatibility, and aerodynamic performance testing (APSD, delivered dose).
  • Strong working knowledge of cGMPs, ICH guidelines, and regulatory expectations for combination products.
  • Proven track record of managing CDMOs, including oversight of technical deliverables, timelines, and budgets.
  • Familiarity with Module 3 CMC documentation, process validation, and stability data requirements.
  • Experience preparing for or supporting NDA/MAA submissions for inhaled products preferred.
  • Strong data analysis and risk assessment skills (e.g., QbD, DoE, FMEA).
  • Exceptional collaboration and communication skills — ability to influence across functional boundaries and external organizations.
  • Comfort operating in fast-paced, lean, biotech environments with high accountability.

Benefits

  • Health insurance
  • Flexible work arrangements
  • Professional development
  • Paid time off

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