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MapLight Therapeutics is a clinical-stage biotech company specializing in drug development for central nervous system disorders, aiming to develop effective the
Associate Director – Formulation Development
Location
Massachusetts
Posted
118 days ago
Salary
$180K - $200K / year
Seniority
Senior
Job Description
Associate Director – Formulation Development
MapLight Therapeutics
• 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.
Job 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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