Inhalation Senior Scientist, Formulation R&D
Amneal•Piscataway Township, NJ
•$90,000 - $115,000
About The Position
The Research Scientist of R&D is responsible for the designing and development various inhaled dosage forms such as solution, suspension, gel, cream, ointment, sterile products etc. This include literature search, pre-formulation studies, prototype development, process scale up and optimization. Responsible to create all the relevant documents and managing of logistics to execute the project in a timely manner.
Requirements
- Scientific leadership for the development of generic pharmaceutical inhaled dosage forms (metered dose inhalers, DPIs, sterile solutions/suspensions).
- Design and conduct pre-formulation studies.
- Manufacture lab-scale batches to identify prototypes.
- Technical leadership for project execution (raw material selection, packaging components, formulation strategy, scientific development, process scale-up).
- Application of Quality by Design principles in experimental design.
- Development of robust formulations and processes.
- Writing technical reports, protocols, batch records, and project presentations.
- Preparation of ANDA submission documents (product formula, manufacturing instructions, product development reports).
- Creative and scientific problem-solving for complex projects.
- Data analysis and action plan proposal.
- Collaboration with inter-departmental groups.
- Coordination of activities for timely project execution.
- Delegation of work to junior scientists.
- Supervision of junior scientists.
- Training and guidance for junior scientists.
Responsibilities
- Provide scientific leadership for the development of generic pharmaceutical inhaled dosage forms such as metered dose inhalers, DPI's and sterile solution suspension etc.
- Design and conduct pre-formulation studies and manufacture lab scale batches to identify prototype.
- 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.
- Write technical reports protocols, batch records and project presentations.
- Prepare ANDA submission documents such as product formula, manufacturing instructions and product development reports.
- Provide creative and scientific solutions to resolve problems while working with complex projects.
- Analyze the data and propose appropriate action plan.
- Work closely with inter-departmental groups and co-ordinates the activities to execute the project in a timely manner to meet the goals.
- Delegate the work to junior scientists and supervise them.
- Provide them necessary training and guidance to overcome any difficulties.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
No Education Listed
