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 companion animal market by applying various formulations skills and knowledge. 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 support the development of novel dosage forms and manufacturing processes for the delivery of drugs to animals, for internal and subcontracted projects i.e. CMOs.
• Prepare formulation development plans to help establish and meet project timelines.
• Lead The Quality by Design (QbD) and Design of Experiments (DOE) approach to develop products and processes that helps identify and control critical factors that affect product quality.
• Collaborate with the global product development team to prepare, execute, and evaluate the stability of laboratory-scale, pilot and industrial scale-up batches, to test a variety of product dosage forms including tablets, liquids, powders, soft chews, sustained-release products and others.
• Troubleshoot problem processes and suggest improvements to manufacturing
• Prepare and authorize manufacturing protocols, Master batch records, change control requests, deviations, development and technology transfer  reports, for all scale-up or production batches.
• Provide guidance to the product development technicians in data collection and analysis.
• Evaluate and compile stability data.
• Prepare product specifications and assemble documentation to support the part II of the Dossier, in collaboration with the analytical and CMC teams.
• Work closely with manufacturing and operations teams, monitoring production runs, and ultimately, transfer of new products to industrial production. Communicate effectively in a timely manner and within a team setting, all information regarding formula and processes development, project status, results, across technical departments and the global project team i.e. Analytical, tech. Reg., QA, API, MSAT/IO etc.
• Engage in continuous learning by attending industry expos and conferences, applying acquired knowledge.
• Adhere to cGMP, GLP, GCP, FDA and EMA legislations and guidelines, whenever applicable.
• Ensure answers to questions from the authorities evaluating AMM files and quality/audits inspections.

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.