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Director, Analytical Development

3 months ago

Burlington, Massachusetts, United States MapLight Therapeutics, Inc. Full time

Who We Are:

MapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. We combine cutting-edge technologies including optogenetics, in vivo physiology, and spatial transcriptomics to identify novel drug targets and develop effective therapies to address psychiatric symptoms.

What Youll Do:

We are looking for an experienced and creative Director, Analytical Development. Reporting to the Vice President, CMC, the Director will manage and lead the Analytical development function ensuring the development and implementation of phase appropriate methods that meet international regulatory requirements for drug substance and drug product safety.

Responsibilities:

  • Using exclusively external resources (CROs and CDMOs) manage and lead all aspects of analytical development including:
  • Identify, develop, and validate analytical methods for different stages of clinical development from pre-IND through commercialization
  • Manage and trend GMP release and stability testing of clinical supplies
  • Support pre-formulation characterization of early-stage assets to inform drug product development exercises
  • Lead efforts for impurity identification as needed
  • Work closely with drug substance, drug product, regulatory and quality teams to ensure that analytical methods are compliant with both relevant regulations and regulatory commitments
  • Collaborate with cross-functional teams to solve technical challenges and provide innovative analytical solutions to characterization challenges
  • Author internal technical reports and regulatory documentation filings/updates. Review external CDMO technical reports and insure they are suitable as supportive regulatory or tech transfer source documents

Qualifications:

  • Degree in Chemistry related field with commensurate experience (BS 14+, MS 10+, PhD 8+), including hands-on experience in multistep synthesis of complex chemical targets
  • Experience managing global (western and non-western) CDMOs with an appreciation of cultural differences and strong communication skills with the ability to articulate (written and verbal) deliverables and project expectations
  • Strong project management and communication skills
  • Extensive understanding of wide variety of analytical technologies for quantification and characterization of drug substance and solid oral drug products
  • Prior experience with developing discriminating dissolution methods for modified release dosage forms a plus.
  • Late-stage method validation experience with a strong appreciation of relevant analytical parameters for method robustness
  • Understanding of important considerations in development of sensitive analytical methods for PGIs
  • Experience interfacing with the early-stage method development activities including pre-formulation activities for pre-IND and FIH clinical studies
  • Experience with development of sound, justifiable control strategies for drug substance and drug product
  • Deep knowledge of ICH Guidelines and their impact on appropriate specification development
  • Expert in the use and interpretation of modern analytical techniques, e.g. HPLC, MS, GC, NMR (1D and 2-D), KF, DSC, TGA, XRD, optical microscopy, particle attribute characterization,
  • Hands-on method transfer experience
  • Ability to manage ambiguity, think critically, and make sound scientific and business decisions when there is limited information
  • Demonstrated ability to problem solve, think strategically, and effectively communicate in a fast-paced environment
  • Ability to conduct, manage, and communicate risk assessments
  • Ability to self-motivate and work independently
  • Flexibility to attend weekly calls, especially with different time-zone Asian CDMOs

Travel:

  • Ability to travel up to 25% of time as needed

MapLight is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.