Associate Director, Drug Product, CMC
BBOT
full-time
Posted on:
Location Type: Remote
Location: United States
Visit company websiteExplore more
Salary
💰 $175,000 - $202,000 per year
Job Level
About the role
- Lead the drug product development strategy for assigned small molecule programs, including solid oral dosage forms and other relevant formats.
- Design, review, and oversee formulation development, process development, and technology transfer activities.
- Develop phase-appropriate Clinical formulations with a view to overall program success on aggressive development timelines.
- Author, review, and approve key CMC documentation including development reports, batch records, and regulatory filings (INDs, IMPDs, NDAs, etc.).
- Manage outsourced development and manufacturing activities at CDMOs, ensuring technical rigor, compliance, and timeline adherence.
- Collaborate with internal CMC stakeholders including Process Chemistry, Analytical Chemistry, Reg CMC, and Supply Chain.
- Collaborate effectively as needed with ex-CMC partners, including Clin Ops, Clin Pharm, Global Reg, Quality, DMPK and Tox.
- Provide technical leadership on drug product troubleshooting, risk assessments, and change controls.
- Ensure activities are compliant with GMP, ICH guidelines, and global regulatory requirements.
- Travel as needed (up to 20%) to support critical manufacturing campaigns and attend company gatherings.
Requirements
- At least 5 years of lab-based experience specifically in small molecule drug product development.
- Ph.D. in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field with 8+ years of relevant industry experience OR M.S. with 12+ years of relevant industry experience.
- Specific experience in Pivotal drug product development, registration batches, validation or commercial.
- Experience with Quality by Design (QbD) and Design of Experiments (DoE) for selection and optimization of drug product.
- Experience in developing BCS Class II/IV drugs.
- Experience directly managing CDMOs and overseeing external development and manufacturing.
- Tech transfer and scale up experience of drug product manufacturing processes.
Benefits
- annual bonus
- stock-based long-term incentives
- medical, dental, and vision benefits
- retirement
- wellness stipend
- flexible time off
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
drug product developmentformulation developmentprocess developmenttechnology transferClinical formulationsCMC documentationQuality by Design (QbD)Design of Experiments (DoE)BCS Class II/IV drugsscale up
Soft Skills
technical leadershipcollaborationrisk assessmenttroubleshootingcompliance management
Certifications
Ph.D. in ChemistryPh.D. in Pharmaceutical SciencesPh.D. in Chemical EngineeringM.S. in related field