3h ago
Associate Director, Formulation Development
Remote (preference for commutable to Burlington, MA)
$180,000-$220,000 / year
full-timedirector Remotebiotechnology
Description
Join MapLight Therapeutics as an Associate Director to lead drug product development from pre-IND to Phase 3, managing external CDMOs and driving formulation strategies. You'll collaborate with cross-functional teams to advance CNS disorder therapies.
Requirements
- BS 12+, MS 8+, or PhD 5+ in Chemistry, Chemical Engineering, or related field
- Experience managing drug product activities at external CDMOs
- Solid oral drug product development from preclinical to late phase
- Knowledge of cGMP and regulatory guidelines
- Strong problem-solving and communication skills
Responsibilities
- Lead development of small molecule solid-oral dosage forms from pre-IND to Phase 3
- Assess API properties for manufacturability, performance, and stability
- Oversee formulation development and GMP manufacturing at CDMOs
- Author/review technical reports and regulatory filings
- Manage vendor relationships and ensure project deliverables
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