Inhalation Scientist, Formulation 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

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.

Education

• Bachelors Degree (BA/BS) Pharmacy or related scientific field - Required
• Master Degree (MS/MA) Pharmacy or related scientific field - Preferred

Experience

• 3 years or more in Bachelor's Degree: Pharmaceutical
• 1 year or more in Master's Degree: Pharmaceutical

Specialized Knowledge

• Operates formulation, manufacturing, and filling equipment used in the development of metered-dose inhaler and dry powder inhaler drug products.

The salary range for this position ranges from $80,000 - $95,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Amneal ranges reflect the Company's good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.