The Manager, Formulation Development will participate and be an expert in the development and scale-up of sterile injectables. The Manager, Formulation Development will supervise scientists, including Research Assistants or Research Scientists or Senior Research Scientists. The Manager will be responsible for successful development of formulations within timelines and cost allocations.
Responsabilities & Duties
Responsible for the development of sterile injectable Supervises a team of scientists and support staff as necessary. Reviews patent information to plan product development strategies. Interacts with analytical, IP, production, warehouse, technology transfer, project managers and regulatory affairs teams to coordinate developmental or logistical activities. Reviews and/or authors responses to, deficiency letters and NON’s issued by regulatory bodies. Reviews and approves development reports and other relevant submission documents. Reviews and approves batch production records under development if needed. Reviews and approves container closure systems for injectables, filter selection etc. Provides vital inputs in exploring and identifying new technologies. Works with contract research organizations and provides planning and technical inputs for execution of all development activities. Provides scientific inputs on in licensed and co-development projects. Evaluates opportunities for continuous improvement related to lab functioning, development timelines and other R&D activities. Performs performance evaluation of staff. Responsible for coaching and training of new employees. Provides support in the recruitment process. Coordinates with suppliers for getting samples of excipients, packaging materials, services, literature, etc, as needed. Supports company initiatives on Lean six sigma. Participates in internal, regulatory and client audits as an SME. Respects cycle time Participates in the validation review board (VRB) when required. Authors, reviews and/or approves documents based on effective procedures and related to laboratory procedures. Skills, Knowledge & Abilities:
The Manager, Formulation Development should have extensive knowledge of development of sterile injectable and ophthalmic products and familiar with GMP principles, regulatory and patent related aspects. The Manager should have developed and gained experience in submission and approval of products to EU, US and Canadian regulatory authorities
No CV Required
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