MapLight Therapeutics
biotech
PrincipalScientist,AnalyticalDevelopment–DrugSubstance
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“Principal Scientist, Analytical Development – Drug Substance at MapLight Therapeutics. Skills: Analytical development, Method development, Method validation, Method transfer, HPLC, GC, LC-MS, NMR, UV, FTIR, Regulatory submissions, GMP/GLP. Lead the development and optimization of analytical methods for starting materials, intermediates and drug substances. Design and lead method validation activities”
What You'll Achieve.
Ensure robust characterization, method development, and regulatory compliance to advance our pipeline through clinical and commercial success
Industry & Context.
What They're Looking For.
Must Have
PhD. in Chemistry, Analytical Chemistry, Pharmaceutical Sciences or related field with 5+ years of relevant industry or M. S. with 7+ 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
Nice to Have
Experience with late phase development activities (registration/PPQ) is a plus
What You'll Do.
Lead the development and optimization of analytical methods for starting materials
intermediates and drug substances
Design and lead method validation activities
Oversee method development and transfer activities to manufacturing or quality laboratories
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
Support regulatory interactions as an analytical subject matter expert
Collaborate with process chemistry scientists
and regulatory affairs
Lead or contribute to multi-disciplinary project teams
Manage analytical development timelines
Communicate progress to stakeholders
How You'll Work.
Team & Collaboration
Collaborate with process chemistry scientists, development teams, quality assurance, and regulatory affairs; Lead or contribute to multi-disciplinary project teams
Communication Scope
Excellent written and verbal communication skills; Ability to present complex scientific data to diverse audiences; Write clear, concise technical documents
Process & Methodology
Manage analytical development timelines, Communicate progress to stakeholders, Capacity to manage multiple workflows and priorities
Full Job Description
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 You’ll Do: We are seeking a highly motivated and experienced Principal Scientist to lead analytical development efforts for small molecule drug substances. This role will support early to late-stage development programs and ensure robust characterization, method development, and regulatory compliance to advance our pipeline through clinical and commercial success. 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. Qualifications: PhD. in Chemistry, Analytic
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