The Role
Lead design and development of sterile pharmaceutical formulations, plan and run experiments and stability studies, analyze results, prepare technical and regulatory reports, support scale-up and tech transfer, collaborate with Production/Quality and cross-functional teams, and manage product lifecycle from ideation to end-of-life.
Summary Generated by Built In
- Designing protocol and development plan for new products. Must have prepared and review developmental Reports.
- Contribute to the development, optimization and evaluation of pharmaceutical formulations for new products or product improvements.
- Work closely with the Research and Development (R&D) team to translate concepts into viable formulations.
- Plan, conduct, and analyze experiments to optimize formulation parameters.
- Perform stability studies and assess the physical and chemical properties of formulations.
- Maintain accurate and detailed records of formulation development activities, experiments, and outcomes.
- Prepare reports summarizing experimental findings and analyses.
- Participate in scale-up activities to ensure the successful transfer of formulations from the laboratory to production.
- Collaborate with Production and Quality teams to address scale-up challenges.
- Ensure Good Laboratory Practices (GLP) and other relevant regulatory standards
- Collaborate with cross functional team to prepare documentation for regulatory submissions.
- Should Prepare technical reports based on analytical results to make conclusions over product technology
- Conduct market research and analyze data to inform product development decisions.
- Manage the product lifecycle from ideation to end-of-life.
M. Pharma with 10+ years of experience in the development of sterile formulations
Skills Required
- M. Pharma (Master of Pharmacy)
- 10+ years of experience in development of sterile formulations
- Experience designing protocols and development plans and preparing/reviewing developmental reports
- Experience in formulation development, optimization, and evaluation
- Experience planning, conducting, and analyzing experiments including stability studies
- Experience with scale-up activities and technology transfer to production; collaboration with Production and Quality teams
- Knowledge of and adherence to Good Laboratory Practices (GLP) and relevant regulatory standards
- Experience preparing documentation for regulatory submissions and writing technical reports based on analytical results
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The Company
What We Do
DifGen Pharmaceuticals is a US-based global pharmaceutical company specializing in the development and manufacturing of complex, high-barrier-to-entry generic and specialty pharmaceutical products. The company focuses on creating dependable solutions in product development and commercialization to increase accessibility to high-quality medications, thereby leading to the creation of next-generation healthy communities.
