MapLight Therapeutics, Inc. · 13 hours ago
Principal Scientist, Drug Substance Process Development
United States
Full-time
Hybrid
Senior Level, Lead/Staff
$172K/yr - $200K/yr
5+ years expMapLight Therapeutics is a clinical stage biotech company focused on drug discovery for central nervous system disorders. They are seeking a highly motivated Principal Scientist to lead small molecule drug substance process development efforts, manage external partnerships, author regulatory documentation, and ensure quality compliance.
BiopharmaBiotechnologyLife ScienceMedical
Responsibilities
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
Qualification
Required
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
Preferred
Prior involvement in late-stage development and tech transfer activities
Familiarity with QbD principles and risk-based development approaches
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
Company
MapLight Therapeutics, Inc.
Maplight is a biopharmaceutical company discovering and developing novel therapeutics for patients with disorders of the central nervous system (CNS).
51-200 employees
H1B Sponsorship
MapLight Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
Funding
Current Stage
Public CompanyTotal Funding
$640.6MKey Investors
Forbion Capital Partners,Goldman Sachs Alternatives5AM Ventures,Cowen Healthcare Investments,Novo HoldingsMichael J. Fox Foundation
2025-10-27IPO
2025-07-28Series D· $372.5M
2023-10-30Series C· $225M
Leadership Team
Vishwas Setia
Chief Financial Officer
Recent News
2026-02-04
2026-01-11
Company data provided by crunchbase