Inhalation Scientist, Formulation R&D

About the role

The Scientist II will support and contribute towards the development of drug products intended for regulatory registration. The primary responsibilities include the development of product and process and the creation of documents for ANDA submission. The Scientist II will take a lead in developmental activities at the bench level and maintain cGMP compliance. The position reports to a Manager, Group Leader, or Principal Scientist as described in the current organization chart of the department.

Responsibilities

• Assist in the development of oral solid formulations, topical (cream, gel), oral liquid, or other dosage forms under the guidance of project leaders.
• Perform experiments and report results.
• Perform literature searches and relevant pre-formulation activities to characterize the brand product.
• Conduct stability studies during development activities.
• Write and review technical documentation including reports, protocols, and other documents for ANDA submission.
• Maintain accurate records and documents.
• Keep up to date with cGMP and maintain compliance.
• Operate formulation, manufacturing, and filling equipment used in the development of metered-dose inhaler and dry powder inhaler drug products.
• Operate lab equipment such as density measurement equipment, balances, pH meters, and other instruments used for the characterization and evaluation of inhalation drug products.
• Perform other duties as assigned.

Requirements

• Bachelor’s Degree (BA/BS) in Pharmacy or a related scientific field.
• Three or more years of pharmaceutical experience with a Bachelor’s Degree.
• One or more years of pharmaceutical experience with a Master’s Degree (MS/MA) in Pharmacy or a related scientific field.

Specialized Knowledge

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

Pay

The salary range for this position is $80,000 – $95,000 per year. Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award within the first 12 months. Individual compensation will ultimately be determined based on qualifications, experience, geographic location, and other relevant skills.