Associate Director – Formulation Development
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Job Description
Associate Director leading drug product development initiatives at MapLight Therapeutics. Collaborating with external CDMOs to develop small molecule solid-oral dosage formulations for CNS disorders.
Responsibilities:
- Lead development of small molecule solid-oral dosage formulations from pre-IND to Phase 3 including:
- Assess API physical and chemical properties as it relates to drug product manufacturability, performance and stability
- Evaluate phase-appropriate formulation approaches and enabling technologies to achieve the target drug product profile
- Design experiments to optimize the formulation and manufacturing process
- Oversee formulation development and GMP manufacturing activities at CDMOs:
- Lead DP endor section activities as necessary ad manage vendor relationship
- Effectively communicate scope of work, timelines, and priorities and monitor the deliverables and performance as it relates to the project objectives
- Drive review of batch records, protocols, reports, and other vendor documents
- Provide technical expertise and guidance to troubleshoot development and manufacturing challenges
- On-site presence for batch manufacturing activities at the CDMO as needed
- Represent formulation development group in cross-functional team and effectively communicate project status and technical risks with appropriate solutions
- Work closely with QA to ensure GMP activities are conducted in accordance with internal QMS
- Author/review internal technical reports and drug product sections of regulatory filings
- You can participate and work effectively with multiple cross-functional teams.
- You have strong interpersonal skills and understand relationships are key to being successful.
- You are a leader. Teams love working with you, and you are someone who takes pride in mentoring and supporting the careers of others.
- You’re a team player who is willing to roll-up your sleeves and get the job done.
Requirements:
- Degree in Chemistry, Chemical Engineering, Pharmaceutical Science, Material Science or equivalent with commensurate experience (BS 12+, MS 8+, PhD 5+)
- Experience managing drug product activities at external CDMOs
- Experience in solid oral drug product development from preclinical to late phase clinical development
- Strong understanding of solid oral dosage formulation technologies, processes and equipment
- Knowledge of chemical and physiochemical techniques used to characterize drug products
- Knowledge of cGMP and current quality and regulatory guidelines
- Demonstrated ability to problem solve, think strategically, and effectively communicate in a fast-paced environment
- Ability to self-motivate and work independently
Benefits:
- annual bonus opportunity
- medical, dental, vision
- life and AD&D
- short term and long term disability
- 401(K) plan with match
- stock options
- flexible non-accrual paid time off
- parental leave
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