Associate Principal Scientist responsible for evidence strategy and planning in Women's Cancer at Merck. Engaging in cross - functional collaboration to assess medical value and reimbursement strategies.
MI
Hybrid Principal Scientist, Drug Substance Process Development
Posted last week
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
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