MapLight Therapeutics, Inc.

Principal Scientist, Drug Substance Process Development

MapLight Therapeutics, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: Burlington • Massachusetts • United States

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Salary

💰 $172,000 - $200,000 per year

Job Level

Lead

About the role

  • Lead the phase-appropriate development, scale-up, and optimization of cost-effective synthetic routes for small molecule drug substances intended for CNS therapeutics.
  • Oversee and manage relationships with CROs and CDMOs to ensure timely and quality delivery of drug substance materials and data.
  • Author and review CMC sections of regulatory filings including INDs, IMPDs, and NDAs. Ensure alignment with global regulatory expectations.
  • Lead investigations and resolution of quality events (e.g., deviations, OOS, OOT). Collaborate with Quality Assurance to ensure compliance with GMP standards.
  • Work closely with Analytical Development, Formulation, Regulatory Affairs, Drug Discovery, and Clinical Supply teams to support integrated development strategies.
  • Drive timelines, budgets, and deliverables across multiple projects. Communicate progress and risks effectively to stakeholders.
  • Prepare and critically review technical reports, protocols, and development summaries with high attention to detail.
  • Foster a collaborative team environment and contribute to cross-functional problem solving and decision making.
  • Promote technical excellence through mentoring, peer review, and continuous improvement initiatives.

Requirements

  • Degree in Synthetic Organic Chemistry or related discipline with relevant industry experience (PhD: 5+ yrs, MS: 10+ yrs, BS: 12+ yrs)
  • Proven track record of managing CRO/CDMO relationships and delivering on CMC milestones.
  • Strong understanding of GMP manufacturing and ICH regulatory requirements.
  • Excellent written and verbal communication skills.
  • Demonstrated ability to manage multiple projects and priorities effectively.
  • High attention to detail and commitment to scientific rigor.
  • Strong team player with a collaborative mindset and ability to work effectively across disciplines.
  • Ability to self-motivate and work independently
  • Flexibility to attend weekly calls, especially with CDMOs in different time-zones
  • Ability to travel up to 25% of time
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
synthetic organic chemistryCMC sections authoringregulatory filingsGMP standardsquality event resolutionanalytical developmentformulation developmentproject managementtechnical report preparationcontinuous improvement
Soft Skills
communication skillsattention to detailcollaborative mindsetself-motivationflexibilityteam playerproblem solvingdecision makingtime managementprioritization