Formulation & Process Development Scientist

Formulation & Process Development Scientist 
Virbac Animal Health is seeking a Formulation & Process Scientist to join our team. Virbac is an animal health pharmaceutical company that specializes in dental, medicine, and supplements for dogs, cats, and ferrets in the United States.
 The Formulation & Process Development Scientist develops new and optimizes existing Pharmaceutical products for the animal health market and evaluate technologies and/or formulation processes. Provide technical expertise in collaboration with other functional groups to develop and/or optimize products, test new ingredients, and issue material and product specifications. 
Experience:  BS in Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree.  2 to 5 years of experience in a pharmaceutical-related field is desired. 
Benefits: 13 Company paid Holidays; 5 personal days (prorated); 15 vacation days (prorated); 5 floating holidays (prorated); 6% 401k match; competitive pay and bonus opportunity; growth opportunities and hybrid schedules based on department and role within the department and much more!

Area of responsibility 1: Development of new pharmaceutical products or optimization of existing pharmaceutical products (R&D roadmap).

Main activities :

• Lead and manage the development of new drug delivery methods for animals, including creating novel dosage forms and manufacturing processes for both internal and outsourced projects.
• Create detailed formulation development plans to help establish and meet project timelines.
• Spearhead the use of Quality by Design (QbD) and Design of Experiments (DOE) to develop products and processes, ensuring product quality by controlling critical factors.
• Collaborate with the global product development team to prepare, execute, and evaluate the stability of various dosage forms, more specifically solids like tablets and chews, as well as powders and liquids, at lab, pilot, and industrial scales.
• Identify and resolve issues in manufacturing processes and recommend improvements.
• Write and approve key documentation, including manufacturing protocols, Master Batch Records, change controls, deviations, and technology transfer reports, for all scale-up or production batches.
• Mentor and guide product development technicians in data collection and analysis.
• Compile and analyze stability data.   
• Draft product specifications and organize documentation for the Dossier, collaborating with the analytical and CMC teams.
• Collaborate closely with manufacturing and operations to monitor production and transfer new products to industrial production.
• Ensure timely communication about project status, results, and formula/process development to all relevant technical and project teams i.e. Analytical, tech. Reg., QA, API, MSAT, IO.
• Engage in continuous learning by attending industry expos and conferences, applying acquired knowledg.
• Maintain compliance with cGMP, GLP, GCP, FDA, and EMA guidelines whenever applicable. 
• Address questions from regulatory authorities and support quality audits.

Expected results:

Ensure products are developed in a timely manner, in agreement with the development plan, and in adherence to applicable regulation requirements.

Ensure the manufacturing process is mastered toward an accurate, robust, and repeatable industrial process.

Area of responsibility 2:
Ensure (maintain/improve) laboratory compliance to GMP/GDP/GCP practices, internal SOPs and safety

Main activities :

• Ensure data integrity and compliance to company SOPs/policies and specifications, FDA and EMA cGMP regulations, and Virbac safety policy.
• Maintain a working knowledge of appropriate scientific instrumentation, equipment, and methodologies in manufacturing, packaging and physico-chemical characterization. A
• Adhere to overall good documentation practices (GDP).
• Identify and support initiation of Deviations, CAPAs and Investigations.

Expected results: Compliance of the R&D formulation lab to GMP/GDP practices, internal SOPs and safety policy.

Profile

Requirements (Diploma and experience)

BS Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree

3+ years of experience in the pharmaceutical-related field.

Skills

This individual has previously demonstrated a high level of Mastery of skills in formulation science and/or process development, project management, in a GMP/GLP environment, either within Virbac or at a previous employer.