What You’ll Do: We are seeking a highly motivated and detail-oriented Principal Scientist to lead small molecule drug substance process development efforts. This role will be instrumental in advancing our pipeline through clinical development by managing external partnerships, authoring regulatory documentation, and ensuring quality compliance. The ideal candidate will bring deep expertise in synthetic organic chemistry, strong project management skills, and a collaborative mindset. We value teamwork and technical excellence and seek individuals who thrive in cross-functional environments and contribute to a culture of innovation.

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.

Qualifications:

• 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 Experience:

• Prior involvement in late-stage development and tech transfer activities.
• Familiarity with QbD principles and risk-based development approaches.