Senior Formulation Scientist (Oral Solids)
Summary
Join a mission-driven, people-first pharmaceutical company as a Senior Scientist in Formulation Development, where you'll play a pivotal role in advancing solid oral drug products from concept to commercialization. This position offers the opportunity to lead technical efforts in formulation design, collaborate cross-functionally, and contribute to the development of high-quality, affordable medications that improve patient lives.
Key Responsibilities
- Design and develop robust non-sterile formulations (e.g., tablets, capsules) for small molecule drug products, ensuring scalability and regulatory compliance.
- Execute formulation experiments, analyze data, and optimize processes to support preclinical through commercial development stages.
- Collaborate with cross-functional teams including Analytical, Regulatory, Quality, and Manufacturing to ensure seamless project execution.
- Support technology transfer activities to internal and external manufacturing sites, including drafting protocols and overseeing scale-up batches.
- Contribute to regulatory submissions (e.g., ANDA, NDA, 505(b)(2)) by preparing technical documentation and responding to agency queries.
- Apply advanced formulation techniques and scientific principles to solve complex development challenges.
- Stay current with industry trends and emerging technologies to enhance formulation strategies and product performance.
Qualifications
- Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, or related field.
- Minimum of 5-7 years of experience in pharmaceutical formulation development, with a strong focus on solid oral dosage forms.
- Demonstrated experience in product development and scale-up, including support for regulatory filings and product launches.
- Proficiency in experimental design, data analysis, and process optimization.
- Familiarity with cGMP, ICH guidelines, and FDA regulatory expectations.
- Strong communication and documentation skills; ability to work independently and collaboratively in a fast-paced environment.
Benefits
Enjoy a comprehensive benefits package that supports your health and well-being, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness programs, and more.
FAQs
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