EPM Scientific
Senior Formulation Scientist (Oral Solids)
EPM Scientific, Houston, Texas, United States, 77246
Summary
Make sure to apply with all the requested information, as laid out in the job overview below. 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.
Make sure to apply with all the requested information, as laid out in the job overview below. 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.