MapLight Therapeutics, Inc. · 9 hours ago
Principal Scientist, Analytical Development – Drug Substance
United States
Full-time
Remote
Senior Level, Lead/Staff
$169K/yr - $195K/yr
5+ years expMapLight Therapeutics is a clinical stage biotech company that focuses on drug discovery for central nervous system disorders. They are seeking a highly motivated and experienced Principal Scientist to lead analytical development efforts for small molecule drug substances, supporting early to late-stage development programs to ensure robust characterization and regulatory compliance.
BiopharmaBiotechnologyLife ScienceMedical
Responsibilities
Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Experienced with a wide range of techniques such as HPLC, GC, LC-MS, NMR, UV, FTIR, and other relevant analytical techniques to ensure method suitability for intended applications
Design and lead method validation activities to ensure methods meet ICH, FDA, EMA, and other applicable regulatory guidelines. Oversee method development and transfer activities to manufacturing or quality laboratories, ensuring clear documentation and effective technology transfer
Prepare, review, and approve technical documents such as standard operating procedures (SOPs), analytical study methods/protocols/reports, and product specifications
Author and review analytical sections of regulatory submissions (IND, IMPD, NDA/MAA) and support regulatory interactions as an analytical subject matter expert
Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs to ensure analytical needs are met across the product lifecycle
Lead or contribute to multi-disciplinary project teams, manage analytical development timelines and communicate progress to stakeholders
Qualification
Required
PhD. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field with 5+ years of relevant industry experience; or M.S. with 7+ years; or B.S with 10+ years
Experience with analytical development in the pharmaceutical, biotechnology or CRO/CMO industry including direct experience with regulatory submissions and GMP/GLP environments
Direct experience working with external manufacturing and analytical/quality sites is essential
Proficiency in chromatographic (HPLC, UPLC, GC), spectroscopic (MS, UV/Vis, FTIR), and other analytical techniques
Experience with method development, validation, transfer, and troubleshooting is essential
Comprehensive understanding of ICH, FDA, EMA, and other health authority guidelines relevant to analytical method development and validation
Excellent written and verbal communication skills, with the ability to present complex scientific data to diverse audiences and write clear, concise technical documents
Capacity to manage multiple workflows and priorities in a fast-paced, evolving environment
Preferred
Experience with late phase development activities (registration/PPQ) is a plus
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