Associate Scientist, Product Development
111 Coolidge Street South Plainfield, NJ 07080
The Product Development Scientist will assist the Manager of Product Development in all aspects of new drug product and process development including but limited to – prototype development, lab stability, document creation, process design and optimization, pilot scale-up, assist the process development group in supervising clinical trial manufacturing material, Registration/exhibit batch manufacturing, and process optimization to full scale commercial batch size. Collaborate with all of the Scientific Affair Department (including Process Development, Analytical R&D, Regulatory Affairs, Clinical and Project Management), commercial manufacturing and quality group. The right person will take a leadership role in development and scale up of product in collaboration with Process Development and Manufacturing group. He/She must know the FDA requirements for GMP, GLP, ANDA, IND/NDA applications, SUPAC guidelines. He/She must be able to write and review product development reports.
ESSENTIAL DUTIES AND RESPONSIBILITIES [Other duties may be assigned]
- Conduct solubility / compatibility trials
- Perform reverse engineering / deformulation
- Design experiments to fabricate prototype formula
- Conduct stability on lab scale batches and interpret data to develop sound conclusions
- Prepare pilot scale batches in pilot lab to determine a suitable process which will yield stable product
- Perform routine equipment calibrations / maintenance
- Collaborate with other departments like Analytical R&D, Quality Assurance, Regulatory affairs, Clinical planning, Process development, Production, purchasing etc to ensure smooth product development
- Assume responsibility in determining channels of exploration or methods of approach, development of recommendations, plans, steps, and techniques to be used.
- Execute the developed plan with minimal supervision evaluating and modifying procedures in consultation with Manager and Director, PPD.
- Verifies that records of work performed are in accordance with FDA requirements and sound scientific standards.
- Prepares, reviews and approves documents prepared for submission to FDA including formula, manufacturing instructions, filling instructions, product development reports, QOS, stability protocols etc. for existing (old) products such as are generated by self or other departments.
- Assists the Process Development Department in manufacturing initial exhibition batches of new products to be used in stability and clinical studies.
- Assists the Process Department, on request, trouble-shooting technical problems affecting currently marketed products.
- Participates in Team Project Management System, departmental seminars, and in meetings with outside consultants as required.
- Keep current with new technology, methods, techniques and drug delivery systems by reading technical journals, attending trainings workshops etc.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, education, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
- M.S. degree with minimum 1-2 years or B.S degree with minimum 3-4 years industrial experience in a scientific discipline (i.e., Pharmacy, Chemical Engineering, chemistry, biology) is required.
- Experience working in a product development capacity, especially in new and/or generic drug development.
- Experience in product development of semi-solid, liquids, and suspension dosage form development preferred.
- Proven knowledge of scientific principles, manufacturing equipment, physical pharmacy.
- Knowledge of FDA regulations and requirements, ANDA, IND/NDA processes and Good Manufacturing Practices
CERTIFICATES, LICENSES, REGISTRATIONS
- Excellent communication skills are required.
- Skills to do standard and/or complex pharmaceutical calculations are expected.
- Should possess enthusiasm, initiative, and ability to solve technical problems.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.