Lead Inhalation Formulation Scientist, R&D

Amneal Pharmaceuticals LLC; Piscataway Township (NJ); On-site; USD 80,000 - 95,000; Full time

Job summary

Amneal is seeking a Scientist II in New Jersey to support drug product development for regulatory filing. You will lead bench development activities, ensure cGMP compliance, and contribute to ANDA submissions with thorough documentation.

The role emphasizes hands-on formulation work across solid, topical, and inhalation products, along with generating and reviewing reports and protocols. Collaboration with project leaders is essential.

Qualifications

• Develop and optimize oral solid formulations and inhalation products.
• Prepare and review technical reports, protocols and other documents for regulatory submission.
• Maintain cGMP compliance and accurate lab records.

Responsibilities

• 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
• 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.

Skills

Formulation development

Analytical reporting

Documentation writing

Inhalation product testing

Education

Bachelor's Degree (BA/BS) Pharmacy or related scientific field - Required

Master Degree (MS/MA) Pharmacy or related scientific field - Preferred

Tools

Inhalation device testing equipment

Job description

Amneal is seeking a Scientist II in New Jersey to support drug product development for regulatory filing. You will lead bench development activities, ensure cGMP compliance, and contribute to ANDA submissions with thorough documentation.

The role emphasizes hands-on formulation work across solid, topical, and inhalation products, along with generating and reviewing reports and protocols. Collaboration with project leaders is essential.