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Associate Director/Director of Pharmaceutical Development
Job in
Minneapolis, Hennepin County, Minnesota, 55400, USA
Listed on 2026-09-14
Listing for:
Scorpion Therapeutics
Full Time
position Listed on 2026-09-14
Job specializations:
-
Pharmaceutical
Pharmaceutical Manufacturing, Regulatory Compliance Specialist, Pharma Engineer, Validation Engineer
Job Description & How to Apply Below
Role
Associate Director/Director of Pharmaceutical Development overseeing drug formulation technology transfers, scale-up, and manufacturing processes for small molecule therapeutics. Objectives include managing external CDMO partnerships, ensuring smooth technology transfer, and supporting regulatory submissions.
Responsibilities- lead late-stage drug product design
- oversee clinical and commercial manufacturing
- author CMC documentation for global filings (IND, NDA, MAA)
- manage vendor governance and production schedules
- Collaborate cross-functionally with analytical, quality, supply chain, and clinical teams
- manage project budgets and risks
- troubleshoot manufacturing issues
- lead process validation efforts
- Ph.D./Master's/Bachelor's in Chemistry, Pharmaceutics, Chemical Engineering, or related field
- 8+ years in small molecule drug product development
- proven experience scaling processes from pilot to cGMP/ commercial scale
- 3+ years managing small molecule CDMOs
- strong knowledge of ICH guidelines, cGMP standards, and QbD principles
- excellent communication and negotiation skills
- experience with small molecule formulations, manufacturing scale-up, and global regulatory filings
- external vendor management
- technical transfer expertise
not specified in the description.
Position Requirements
10+ Years
work experience
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