Inhalation Scientist, Formulation R&D

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

Benefits offered by this job

Bonus opportunity

Job summary

Amneal seeks a Scientist II to support development of drug products for regulatory submission. You will develop product and process and prepare documents for ANDA submission, taking a lead role at the bench while ensuring cGMP compliance.

Education: BA/BS in Pharmacy or related field required; MS/MA preferred. Experience: 3+ years with a Bachelor's or 1+ year with a Master's; inhalation device development experience valued.

Qualifications

• Bachelor's Degree (BA/BS) Pharmacy or related scientific field - Required
• Master Degree (MS/MA) Pharmacy or related scientific field - Preferred
• 3 years or more in Bachelor's Degree: Pharmaceutical
• 1 year or more in Master's Degree: Pharmaceutical

Responsibilities

• Develop oral solid formulations, topical and other dosage forms under guidance.
• Conduct literature search and pre-formulation activities; perform stability studies.
• Write and review technical documentation for ANDA submissions.
• Maintain accurate records and ensure cGMP compliance in development.
• Operate equipment used for inhaler drug product development.

Education

Bachelor's Degree in Pharmacy or related field

Master's Degree in Pharmacy or related field

Tools

Density measurement equipment

pH meters

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.