Job DescriptionDescription: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.
QualificationsEducation:- 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.
