Associate Director, Drug Product Manufacturing and Development (Oral)

• Contribute to the selection, engagement, and management of CDMO’s, including assessment of capabilities, drafting requests for proposals, and providing recommendations based on selection criteria
• Coordinate technology transfer, formulation and process development, optimization, scale-up and manufacturing of clinical supplies, acting as Kailera’s person-in-plant for activities critical to program success
• Collaborate closely with internal cross-functional teams, including Drug Substance, Analytical Development, Supply Chain, Clinical, Quality Assurance, and Regulatory Affairs to ensure seamless progression of projects
• Review master batch records and executed batch records to ensure product quality
• Manage cGMP change controls and manufacturing deviations as necessary, working closely with Kailera’s quality group
• Lead initiatives to enhance manufacturing efficiency, reduce costs and improve product quality through experimental design with a focus on commercial preparedness
• Author, review, and update CMC specific documents to support worldwide regulatory submissions (i.e., IND, IMPD and NDA)

• 10+ years of experience in the pharmaceutical industry with a proven track record of technical expertise in unit operations common to solid oral dosage form (e.g., dry granulation, compression and film-coating)
• Extensive experience with management and oversight of activities at CDMO’s
• Strong troubleshooting skills with the ability to quickly provide input in a fast-paced environment
• Strong working knowledge of Excel, Word, PowerPoint
• Experience drafting CMC documents for regulatory filings
• Experience using quality systems such as Veeva to author and approve documents
• Excellent verbal, written and interpersonal skills
• Innovative team-player capable of working cross-functionally to achieve program goals
• Ability to travel up to 20% (domestic and international)
• Bachelors Degree in Engineering, Pharmaceutical Sciences, Life Sciences or closely related field

Experience in the GLP-1 space

• Comprehensive health benefits and tax-advantaged savings accounts
• Flexible time off, 13 paid holidays, and a companywide year-end shutdown
• Monthly wellness stipend
• Generous 401(k) match
• Disability and life insurance