About the Role:
Responsible for leading analytical development activities for multiple projects to support drug substance development from preclinical through commercial phase, focused on small molecules. Develop, establish, and validate testing methods for raw materials, in-process testing, intermediates, and API. Develop and implement control strategies with emphasis on advancing analytical innovation. Ensure work complies with cGMP, safety, and regulatory requirements. Participate in analysis and evaluation of materials/products at all development stages; monitor and evaluate task/project completion.
Your Contributions:
- Plans and manages projects; represents Analytical Development on cross-functional teams; accountable for analytical deliverables and CMC plan progress.
- Independently designs, plans, and executes analytical chemistry activities for pre-clinical through commercial goals and control strategy contributions.
- Supervises laboratory work/lab personnel; ensures safe lab practices.
- Performs analytical development and optimizes methods for preclinical through commercialization.
- Creates and implements novel API-development analytical techniques.
- Supports off-site analytical transfers, manufacturing support, and contractor interactions.
- Provides input into CMC regulatory documentation.
- Supervises laboratory personnel; supports their professional development.
- Contributes to policies and department strategies; builds relationships; presents findings; supports career development; other duties as assigned.
Requirements:
- BS/BA in Analytical Chemistry (or related) + 12+ years analytical/pharmaceutical development experience (method transfer). OR MS/MA + 10+ years. OR PhD + 4+ years (may include postdoc).
- Thorough analytical chemistry/process chemistry understanding.
- Proficiency in drug substance characterization techniques (e.g., LC, GC, IR, MS, NMR, KF, UV).
- cGMP knowledge for API and drug product.
- Strong communication, laboratory productivity, method development/validation/transfer expertise.
- Cross-functional drug development understanding; leadership; project management; excellent computer skills; ability to lead multiple teams.
Benefits/Comp:
- Annual bonus (target 30% of earned base salary) and equity long-term incentive eligibility.
- Retirement savings plan (company match), paid vacation/holidays/personal days, caregiver/parental and medical leave, and medical/prescription/dental/vision coverage (per plan terms).