Formulation Scientist

Kelly Science has multiple openings for a Formulation Scientist from Senior Scientist to Principal Scientist with one of our growing clients in the Miami FL area.

The successful candidate will conduct, lead and supervise evaluation and selection of raw materials, pre-formulation, formulation and process development studies for Orally Inhaled and Nasal Drug Products (OINDPs)

Location : Miami FL

Shift : Monday-Friday 8am-5pm

Salary Range : $80,000-$140,000 / year depending on experience

Essential Duties and Responsibilities

• Independently conduct, lead and supervise standard and advanced laboratory activities for the development of OINDP formulations following regulatory guidelines US FDA cGMPs, and other relevant guidelines.
• Independently design and lead pre-formulation, formulation and process development studies to recommend selection of APIs, excipients, packaging material and manufacturing process.
• Independently design and develop manufacturing processes and conduct manufacturing activities for OINDP products.
• Possess good understanding of other inhalation technologies.
• Evaluate and introduce new technologies; be capable of generating new practical ideas; possess strong understanding of experimental design.
• Provide expert support for manufacturing related technical issues.
• Write protocols, reports, methods and standard operation procedures.
• Write regulatory submission modules and any other documents to support submission and product approval.
• Develop statistical design of experiments with minimal supervision.
• Work and communicate effectively with other functional groups and across global respiratory R&D sites.
• Independently lead major project tasks.
• Establish and maintain effective relationships with team members.

Qualification Requirements

• PhD., in Pharmaceutical Sciences or related discipline with 6 to 12 years, MS with 12+years research experience in pharmaceutical or related field.
• Must possess expert knowledge of development orally inhaled and nasal products (OINDPs).
• Knowledge of manufacturing processes of OINDP products is a plus.
• Knowledge and in-depth understanding of global regulatory requirements as applied to OINDPs.
• Excellent understanding of USP methodologies and ICH Deep knowledge of the FDA cGMP requirements as they apply to the pharmaceutical industry.
• Strong English language skills including writing ability and oral communication. Experience with writing of chemistry, manufacturing and control (CMC) sections of US and EU regulatory documents (NDA, ANDA, IND, IMPD).

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