MapLight Therapeutics, Inc.

Associate Director – Formulation Development

MapLight Therapeutics, Inc.

full-time

Posted on:

Location Type: Remote

Location: Massachusetts • United States

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Salary

💰 $180,000 - $200,000 per year

Job Level

Senior

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
solid oral dosage formulationAPI physical and chemical propertiesformulation developmentGMP manufacturingbatch records reviewtechnical report authoringdrug product developmentchemical characterization techniquesphysicochemical techniquescGMP compliance
Soft Skills
interpersonal skillsleadershipmentoringteam collaborationproblem solvingstrategic thinkingeffective communicationself-motivationindependent workrelationship management