The Scientist III develops and executes formulation strategies related to product development, such as project planning, experimental design and data evaluations. The Scientist III applies technical expertise and has knowledge of various formulation development approaches.
Demonstrates leadership and experience in the area of pre-formulation, formulation and process development of Topicals (cream, gel) and Oral liquid. The position reports to a Manager/ Principal Scientist as described in the current organization chart of the department.
Essential Functions
Develops formulation strategy and designs experimental plan, formulation and process development work for oral controlled release and immediate release dosage forms, Topicals, (cream, gel), Oral Liquid, and Transdermal products.
Responsible for selection of raw materials, packaging components and process requirements based on sound scientific principles.
Reviews analytical and clinical data and makes scientific conclusions.
Writes and reviews protocols and batch records for process development and evaluation work, scale up and pivotal batch manufacturing.
Creates and reviews technical documents, reports and presentations for cross functional teams. Writes Modules of ANDA's for submission.
Maintain Design history files for combination products. Develop design and development plan.
Keeps updated on cGMP and current technologies.
Additional Responsibilities
Provides scientific and technical direction to junior staff members (scientists I, II, technicians & operators) to ensure project deadlines and performance standards are met.
Identifies, analyzes and suggests corrective actions to optimize R&D processes, technologies and regulatory compliance issues
Equipment: Becomix, Tube filler, Transdermal and liquid manufacturing equipment
Reviews Junior Scientist work
Education
Master Degree (MS/MA) in Pharmaceutical, Chemistry or related technical field - Preferred
Bachelors Degree (BA/BS) in Pharmaceutical, Chemistry or related technical field - Required
Work Experience
3 years or more with a Master Degree in Development of Pharmaceutical Dosage Forms - Required
5 years or more with a Bachelors Degree in Development of Pharmaceutical Dosage Forms - Required
Skills and Abilities
Must have knowledge of Pharmaceutical product development and manufacturing process. - Intermediate
Must be precise and consistent in day to day developmental work, easily trainable and ready to learn. - Intermediate
Must be able to effectively communicate reports, problems or issues, verbally as well as in writing. - Intermediate
Must have good oral and written communication skills. - Intermediate
Must be able to work in a team environment and be flexible to easily adapt to changes in assignments. - Intermediate
Must follow safe practices as defined by the SOP's and MSDS. - Intermediate
Must be willing to work extended hours as and when required. - Intermediate
Strong interpersonal skills and maintaining cooperative working relationships with others. - Intermediate
Managing multiple projects, duties and assignments. - Intermediate
Specialized Knowledge
Must have a good understanding of topical and oral liquid formulations and processes.
Must possess in-depth knowledge of the operation and troubleshooting skills for various lab scale equipment to production scale equipment: including Mixers, Homogenizers, Scale Up equipment, Tube filling machine and bottle filling machine.
Must have a good understanding of preparation of ANDA submission documents such as PDR, QOS, etc.
Works independently once assignments and responsibilities are outlined and delegated. Effective in oral and written communication skills at all levels and cross functionally.
