Senior Pharmaceutical Development Scientist
4 days ago
At Bend Bioscience, we are seeking a highly skilled Senior Pharmaceutical Development Scientist to join our team. In this role, you will be responsible for the formulation development and process optimization of challenging pharmaceutical products such as controlled-release oral solid dosage forms (tablets, multiarticulate, etc.).
About the RoleThe successful candidate will have at least 12 years of experience in formulation and process development of oral solid dosage forms with a bachelor's degree or equivalent. They will also have strong knowledge of common pharmaceutical raw materials, their applications, and the principles of formulation development.
In addition to the above requirements, the ideal candidate will have proven experience with statistical design of experiments and a strong working knowledge of regulatory requirements, including FDA, EMEA, ICH, and regulations in regard to IID, GRAS, residual solvents, bioequivalence studies, etc. for oral formulations.
Responsibilities- Independently lead development activities for client-based projects, ranging from preclinical studies to NDA approval.
- Execute prototype, scale-up and process transfer activities including manufacture, data evaluation, troubleshooting product/process issues, and risk assessments.
- Maintain expert knowledge of equipment, instrumentation, and procedures related to product development.
- Write, review, and approve cGMP documentation, including batch records, protocols, SOPS, pharmaceutical development reports, investigation plans, and outcomes for development problems, etc.
- Bachelor's degree in Pharmaceutics, Physical Organic Chemistry, Pharmaceutical Chemistry, Chemical Engineering, Pharmacology or a master's degree with 8 years of relevant experience.
- A minimum of 1 year of experience leading and managing teams.
We offer a competitive salary of $140,000 per year, along with a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.
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