Lead Process Chemist
We are a growing Boulder-based organization seeking a Process Chemist to work with our CMC team.
The Process Chemist will be responsible for development of GMP processes at multiple Contract
Manufacturing Organizations and will support the chemical, quality, and regulatory strategies required
t to successfully complete key manufacturing milestones. Primary responsibilities include:
- Support external manufacturing activities at drug substance and drug product contract manufacturers
- Review master batch records
- Review investigation documentation
- Provide guidance during deviation investigations
- Review executed batch packages
- Author manufacturing batch summary reports
- Support external process development activities at drug substance and drug product contract manufacturers, including:
- Review study protocols and reports
- Provide guidance during study execution
- Author process development summary reports
- Support process validation activities at drug substance and drug product contract manufacturers
- Execute/support process risk assessments
- Lead process validation planning activities
- Identify and design process characterization studies
- Perform analysis of process characterization data to determine parameter classifications
- Review process performance qualification protocols and reports
- Review regulatory submission sections related to process development and manufacturing
Qualifications and Required Skills:
- A Bachelor’s degree in Organic Chemistry, Chemical Engineering or similar field and a minimum eight (8) years of Process Chemistry experience in the biopharma industry. Advanced degree preferred.
- Experience in the process development and technical transfer of methods and processes used in the manufacturing of oligonucleotides is preferred but not requisite.
- Demonstrated ability to manage CRO and CMO contracts and activities.
- Proven track record in conducting scientific research, with highly developed problem solving and decision-making skills.
- Solid understanding of all facets and phases of CMC drug development.
- Expertise in the implementation and qualification/validation of methods.
- Thorough knowledge of GMP regulations required for testing of finished product for human clinical studies.
- Knowledge of CMC requirements for regulatory filings covering all phases of pre-clinical and clinical development in both the US and ex-US markets.
- Demonstrated technical and project management capabilities.
- Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills.
- The ability to work collaboratively and effectively on a multi-disciplinary team.
- Demonstrated success managing multiple assignments with timely and accurate output.
- Some travel may be required (approximately 5%-10%)