Inhalation Scientist, Formulation R&D

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

Job summary

Amneal is seeking a Scientist II to help develop drug products for regulatory registration and to prepare documents for ANDA submission. This role leads developmental activities at bench level and ensures cGMP compliance while reporting to a Manager/Group Leader/Principal Scientist.

The position emphasizes development of formulations for various dosage forms and requires hands-on bench work, documentation, and equipment operation related to inhalation products.

Qualifications

• Bachelor's degree in Pharmacy or related field required.
• Master's degree preferred.
• Minimum 3 years of pharmaceutical experience with Bachelor's degree.

Responsibilities

• Assist in development of oral solid formulations, topical creams/gels, or liquids 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.
• Operate formulation/manufacturing/filling equipment for inhaler drug products.

Skills

Drug formulation

cGMP compliance

Bench-scale development

Documentation/writing

Education

Bachelor's Degree in Pharmacy or related field

Master's Degree in Pharmacy or related field

Tools

Density measurement equipment

Balances

pH meters

Lab equipment operation

Job description

Job 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.

Qualifications

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.

About Us

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.

About The Team

Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key roles that the Human Resources team performs:

• Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.


• Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.


• Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.


• Consultancy Role: Provide expert advice to the organization and it's managers on any aspect of workforce management and employee relations and performance.


• Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.