Inhalation Scientist, Formulation R&D

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 80,000 - 110,000; Full time

Job summary

Amneal Pharmaceuticals LLC in New Jersey is seeking a Scientist II to support development of drug products for regulatory registration. The role leads bench-level developmental activities and prepares documents for ANDA submissions, reporting to a Manager/Group Leader/Principal Scientist.

Responsibilities include formulating oral solids, topical, and inhalation products; performing literature searches, pre-formulation studies, and stability testing; writing technical reports and protocols;

Responsibilities

• Formulates and tests oral solid formulations, topical creams/gels, liquids, and other dosage forms under guidance.
• Performs literature searches and pre-formulation activities to characterize brand products; conducts stability studies during development.
• Writes and reviews technical documents including reports, protocols, and other documents for regulatory submissions (ANDA).
• Maintains accurate records and ensures cGMP compliance throughout development.
• Operates formulation, manufacturing, and filling equipment for inhalation products (MDI, DPI) and lab instrumentation.

Job description

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. Operateslab 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.