A fast-growing generics company based in New Jersey is seeking a Sr. Manager to join its formulation team. Should have 7-10 years of experience in an industrial setting. Background should be in generics, predominantly in topicals. The role involves bench work, but also comes with administrative and mentorship responsibilities.
The Sr. Manager of R&D is responsible for the design and development various dosage forms such as solution, suspension, gel, cream, ointment, sterile products etc. This includes literature search, pre-formulation studies, prototype development, process scale-up and optimization. Responsible for creating all the relevant documents and managing the logistics to execute the project in a timely manner.
- Provide scientific leadership for the development of generic pharmaceutical topical products such as creams, gels, ointments, topical solutions/suspension, sterile solution/suspension etc. Design and conduct pre-formulation studies and manufacture lab scale batches to identify prototype. (25%)
- Provide technical leadership to ensure timely execution of projects starting with the selection of raw materials, packaging components, formulation strategy, scientific development and process scale-up. Apply Quality by Design principles in the design of experiments to develop robust formulation and processes. (25%)
- Write technical reports protocols, batch records and project presentations. Prepare ANDA submission documents such as product formula, manufacturing instructions and product development reports. (20%)
- Provide creative and scientific solutions to resolve problems while working with complex projects. Analyze the data and propose appropriate action plan. (10%)
- Work closely with inter-departmental groups and coordinate the activities to execute the project in a timely manner to meet the goals. (10%)
- Delegate the work to junior scientists and supervise them. Provide them necessary training and guidance to overcome any difficulties. (10%)
M.S. with 7+ years of relevant industrial experience in formulation.