Sr. Scientist, Formulations

Job Details

Level
Experienced

Job Location
Pegasus - Pensacola, FL

Position Type
Full Time

Education Level
4 Year Degree

Travel Percentage
Up to 15%

Job Shift
Day

Job Category
Research

Sr. Scientist, Formulations

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!

This Sr. Scientist, Formulations position provides technical leadership and project management in the development of new product formulations, technical transfer, and support of company strategy. This senior technical role is involved and leads in all aspects of Product Development. This role will provide technical, logistical, and financial project management as well as contribute to the development of company intellectual property. This position will serve as product SME throughout the lifecycle of assigned products, a Product Creator. This role will require coordination with all technical and quality departments as well as marketing (product design and label claim development) and Operations.

1. Responsible for development of new product and product line formulations supporting company strategic initiatives.
2. Design, write, and execute development protocols and reports; report progress in project meetings.
3. Develop and manage project plans including timelines and budgets/contractual bids for technical services work.
4. Write justifications and design selection for raw material and primary packaging materials. Work with Procurement department and supporting vendors to provide technical expertise in defining user requirements.
5. Design, write, and execute development protocols and reports for engineering studies and clinical supplies.
6. Manages 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.
7. Must be able to define the purpose and objective of the studies to appropriately design experiments and protocols.
8. 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.
9. Responsible for training and transfer of new products to commercial operations.
10. Must be able to manage project budget aspects including time and material costs, net profit, and monthly tracking of incurred material costs and tracking labor hours on assigned projects.
11. All other duties as may be assigned.

Preferred Qualifications

• Education: BS, MS, or PhD in Chemistry, Biomedical Engineering, Pharmaceutical Sciences or a related field from an accredited university required. Studies or certifications in project management or business management are a plus.
• Specialized knowledge or training: Must have a pharmaceutical, cGMP, background with an FDA regulated laboratory. Familiar with USP, ICH, and VICH guidelines as well as fundamental principals of project management. Must have strong technical writing and documentation skills.
• Experience: 3+ years' work related experience required with PhD, prefer 7+ years' experience with BS or MS degree required; experience in pharmaceutical formulations to include expertise in bioequivalence studies, PK/PD modeling, and/or process design. 3+ years in project management or expense budgeting required.
• All candidates with experience will be considered for this role.

Pegasus is an equal opportunity employer.