Senior Scientist, Formulations
- Lead and direct drug product formulation development and manufacturing from conception through clinical development and to commercialization
- Partner within pharmaceutical development to define drug product critical quality attributes and control strategies
- Evaluate and select phase appropriate, including commercial, manufacturing partners for drug product formulation and packaging
- Manage drug product relationships with CDMOs to define and drive technical deliverables, ensuring timely delivery of analytical data to support pharmaceutical development and clinical trials
- Review and approve formulation and process development protocols and reports for feasibility, formulation optimization, and scale-up
- Review and approve master and executed batch records for formulation and packaging
- Analyze/interpret development data to support technical decision making, trend analysis, and root cause investigations
- Effectively manage change controls, deviations, and CAPAs to quality standards
- Organize and lead authoring of regulatory submissions within Pharmaceutical Development, with expertise in drug product development and manufacturing regulatory file sections. Coordinate input across other technical domains and vendors
- Form the Pharmaceutical Development strategy needed to meet program milestones on-time and to quality standards
- Represent Pharmaceutical Development on cross-functional clinical study and global program teams
- Identify, assess, and drive key Pharmaceutical Development technical decisions and risk mitigations
- Manage and lead drug product CDMO interactions in order design, track, and deliver on development milestones
- Serve as subject matter expert in formulation, and/or drug product manufacture
- Partner with Project Management, Clinical Operations, and Contract Organizations to ensure clinical trial material is packaged, labeled, and supplied on-time and right first time
- Bachelor of Science degree in Chemistry or relevant discipline with a minimum of 5 years of pharmaceutical industry experience
- Strong working knowledge of current Good Manufacturing Practices (cGMP)
- Strong working knowledge of relevant regulatory requirements, pharmacopeias, and ICH guidance
- Subject matter expert in solid oral formulations, dosage forms, and manufacturing processes, including scale-up and risk management
- Proven track record for partnering internally and externally to deliver Pharmaceutical Development milestones on-time and right first time
- Ability to effectively collaborate, communicate, and influence in a cross-functional team environment
- Experience with US and EU regulatory filings, preferably both at the clinical trial and marketing application stages
- 100% paid health benefits including Medical, Dental and Vision for you and your dependents
- 401(k) program with company match and immediate vesting
- Flexible time off
- Generous parental leave and some fun fringe perks!
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