Inhalation Scientist, Formulation R&D

Description:

Scientist II will support and contribute towards the development of the drug products intended for regulatory registration. The primary responsibilities include the development of product and process and create the documents for ANDA submission. The Scientist-II will take a lead in the developmental activities at the bench level and maintain cGMP compliance. The position reports to a Manager/ Group Leader/ Principal Scientist as described in the current organization chart of the department.

Essential Functions:

• Assist in development of oral solid formulations, Topical (cream, gel), Oral liquid or other dosage form under the guidance of project leaders. Performs experiments and reports results
• Performs literature search and relevant pre-formulation activities to characterize the brand product. Conduct stability study during development activity.
• Writes and reviews technical documentation including reports, protocols and other documents for ANDA submission.
• Maintains accurate records and documents. Keeps up to date with cGMP and maintains compliance.
• Operates formulation, manufacturing, and filling equipment used in the development of metered-dose inhaler and dry powder inhaler drug products. Operates lab equipment such as density measurement equipment, balances, pH meters, and other instruments used for the characterization and evaluation of inhalation drug products.

Additional Responsibilities:

• Other duties as assigned.