Associate Director/Director of Pharmaceutical Manufacturing Science and Technology
About Ascendia Pharmaceuticals:
Ascendia is a specialty pharmaceutical CDMO company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. Ascendia specializes in creating formulations for poorly-water soluble molecules using nano-particle technologies. Ascendia assesses the feasibility of a broad array of formulation options in order to improve a drug’s bioavailability and solubility. Ascendia’s technologies include nano-emulsions, amorphous solid dispersions, nano-particles, injectable, and controlled release. Ascendia provides development, GMP manufacturing, and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up.
The mission of our company is to provide customized formulation solutions to “salvage” difficult compounds and to create advanced medicines to help patients “prevail” over their disease and enhance quality of life.
About the Position:
The Associate Director/Director of Pharmaceutical Manufacturing Science and Technology will be mainly responsible for managing development and manufacturing of multiple sterile pharmaceutical products for small molecules and biological therapy entities and overseeing those activities at manufacturing facilities from pre-IND to late-stage manufacturing and product validation.
- Work with internal and external cross-functional CMC team, plan and execute development/ manufacturing strategies to support human clinical supply.
- Manage the manufacturing science and technology group and the department objectives and budget.
- Provide leadership for process development/scale-up/validation/transfer activities at internal and external manufacturing sites.
- Coordinate new drug product in-process and release testing in a timely manner and develop appropriate process flow and control strategy for the manufacturing.
- Input to the team in the scientific guidance for study design, data analysis and troubleshooting of process related issue, and contribute to analysis and monitoring for manufacturing deviations and investigations.
- Present results and progress of development and manufacturing programs to internal and external clients.
- Prepare and review documents related to development and GMP operations to support regulatory filings.
- Work collaboratively with Quality Assurance to ensure cGMP compliant.
- BS/MS/PhD in Pharmaceutical Sciences, Chemistry, Microbiology, Chemical/Biomedical Engineering, Materials Science or other related discipline required.
- Minimum 5-years pharmaceutical experience in product development and manufacturing for sterile products.
- Extensive hand-on experience in formulation, process developing, and scaling up of sterile products from pre-IND through late-stage development and commercialization.
- Working experience with an in-depth knowledge of sterile product manufacturing process flow, aseptic processing, sterile manufacturing, unit operations, process control under cGMP environment in a CDMO is preferred.
- Demonstrated capability to lead and manage multiple product development and manufacturing projects is required.
- 5-year plus working knowledge of FDA/ICH/EMA guidelines and cGMPs, familiar with requirements for IND, NDA, and BLA submissions and experience with IND/BLA/MAA documentation.
- Understanding principles of Quality by Design (QbD) and Design of Experiment (DoE) for optimization of drug product formulation and/or manufacturing process.
- Excellent communication skills for collaboration with internal management and external partners are required.
Please visit our website at www.ascendiapharma.com for more information.