Formulations Scientist

Job Details

Level

Experienced

Job Location

Pegasus - Pensacola, FL

Remote Type

N/A

Position Type

Full Time

Education Level

4 Year Degree

Salary Range

Undisclosed

Travel Percentage

Negligible

Job Shift

Day

Job Category

Research

Pegasus Laboratories, Inc.

Pegasus Laboratories, Inc. is a full-service Contract Development and Manufacturing Organization, or CDMO, with a very special purpose: improving the lives of animals. Through our leading veterinary brand, PRN Pharmacal, we create trusted veterinary products that promote animal wellness, including behavior modification, urinary incontinence, and seizure management. Our team of professionals, including manufacturing, quality assurance, business development, scientists and chemists, regulatory experts, and veterinarians, offers the complete package, from idea through development and regulatory approval, to production and marketing.

Pegasus Labs, part of the PBI-Gordon Companies, Inc., is 100% employee-owned with more than 500 employee-owners, working together in pursuit of mutual success. We are growing - come join us!

Formulations Scientist provides technical leadership in development of new product formulations, process scale-up, and support of clinical trials; and to serve as key technical support to existing product lines.

• Responsible for development of new product and product line formulations.
• Design, write, and execute development protocols and reports; manage project timelines and report progress in project meetings.
• Write justifications and design selection for raw material and primary packaging materials. Work with supporting vendors to provide technical expertise in defining user requirements.
• Design, write, and execute development protocols and reports for engineering studies and clinical supply.
• Provide technical support to validation projects and ensure all validation documentation is finalized, current and archived as required.
• Oversees multiple development projects at various stages from proof of concept through stability and validation in support of Chemistry and Manufacturing Controls (CMC) filing with FDA.
• Must be able to define the purpose and objective of the studies to appropriately design experiments and protocols.
• Must be able to analyze and review raw data and interpret results (i.e., pharmacokinetic studies) to provide technical guidance to management and peers of multiple departments.
• Responsible for training and transfer of new products to commercial operations.
• All other duties as may be assigned.

Qualifications:

• Education: BS, MS, or PhD in Chemistry, Biomedical Engineering, Pharmaceutical Sciences or a related field from an accredited university.
• Experience: 3+ years required with advanced degree, prefer 7+ with BS degree; experience in pharmaceutical formulations to include expertise in bioequivalence studies, PK/PD modeling, and/or process design. Expertise in analytical development with dissolution, HPLC, GC, FTIR, and raw material evaluation is a plus.
• Specialized knowledge or training: Must have a pharmaceutical, cGMP, background with an FDA regulated laboratory. Familiar with USP, ICH, and VICH guidelines.
• Other Skills: Strong project management, technical writing, and documentation skills (cGMP, protocols, reports, OOS investigations, lab notebooks)
• Travel required in this position 0-10%