What You’ll Do:

We are seeking a motivated and talented Associate Director to join the formulation development group in the CMC department.  Reporting to the Director of Formulation Development, the desired candidate will lead drug product development initiatives in collaboration with external CDMOs for MapLight’s pipeline programs.  This is a great opportunity to join a small team and grow in a fast-paced environment to bring drug products from initial concept to patients.

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.

Qualifications:

• 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

Location:

• This is a hybrid position with three days per week onsite at our office in Burlington, MA.

Travel:

• Ability to travel up to 25% of time