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.