Hybrid Principal Scientist, Drug Substance Process Development

at MapLight Therapeutics, Inc.

• Job title: Principal Scientist, Drug Substance Process Development
• Job type: Full Time
• Experience level: Lead
• Salary: $172,000 - $200,000 per year
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Burlington, United States

About the role

• Principal Scientist leading small molecule drug substance process development at a biotech company. Responsible for managing external partnerships and ensuring regulatory compliance in a collaborative environment.

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.

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