A leading pharmaceutical dentistry company is seeking a Senior Formulation Scientist for its new-but-growing team in Huntsville, AL, working at a state-of-the-art facility.
Senior Formulation Development Scientist will be primarily responsible for formulation and process development activities related to new generic products. Should be able to design and execute formulation development trials as per Quality by Design (QBD) and evaluate stability data to finalize final formulation composition. Will utilize professional skills to recognize problems related to formulation, process, packaging with respect to large scale production. Also provide technical support during process validation and cleaning validation studies and monitor the manufacturing of exhibition batches in support of new product submissions to FDA.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Design and supervise execution of formulation trials as per QBD and evaluate stability data to finalize formulation composition.
- Develop manufacturing processes for R&D formulations so that the technical transfer is successful.
- Coordinate sourcing of APIs, excipients, packaging components for new products to meet regulatory requirements
- Write/review master formulas, manufacturing procedures, SOPs, stability protocols/reports, process validation protocols/reports, Product Development Reports etc.
- Prepare/review specifications for drug products and packaging components etc.
- Write/review product development report.
- Write/review Overall Quality Summary (OQS).
- Coordinate the manufacturing of exhibit/submission batches per regulatory requirements
- Perform technology transfer for manufacturing processes from laboratory scale to the production scale
- Provide technical support during process validation and cleaning validation studies
- Coordinate with Analytical Method Development, Regulatory Affairs, Quality Control, Quality Assurance, Inventory Control etc. to expedite the development and approval of new products by FDA.
- Assure that all formulation and process development activities are documented as per cGLPs.
- Assure that the manufacturing and testing of the exhibit batches in support of all ANDA applications are done on time to meet submission targets.
- Coordinate the timely and quality response to any FDA deficiency letters related to ANDA submissions.
WORK PERFORMED: (approximate breakdown by percentage)
- Formulation Development: 50%
- CMC Technical Documents: 30%
- Supervise Submission Batch: 20%
- Hands on experience in formulating semi-solids (creams, ointments, gels, lotions) and oral and topical liquid dosage forms is preferred.
- Hands-on experience in developing generic pharmaceuticals as per QBD
- A sound knowledge of regulatory requirements for product development and cGMPs is essential.
- Should have excellent planning, project management, verbal and written skills.
EDUCATION AND EXPERIENCE
- M.S, Ph.D. in Pharmaceutical Sciences or related field with 5-7 years of experience in generic pharmaceutical environment. Ph.D. is preferred.