Formulation & Process Development Scientist

Virbac•Bridgeton, MO

1d•Hybrid

About The Position

Virbac Animal Health is seeking a Formulation & Process Development Scientist to develop new and optimize existing pharmaceutical products for the animal health market, evaluate technologies and formulation processes, and provide technical expertise in collaboration with other functional groups. The role supports products for animals, including novel dosage forms and manufacturing processes, and works on internal and outsourced projects. The scientist develops formulation plans, applies Quality by Design (QbD) and Design of Experiments (DOE), and collaborates with the global product development team to prepare, execute, and evaluate stability studies at laboratory, pilot, and industrial scales. Product forms include tablets, chews, powders, and liquids. The position also supports scale-up and production, investigates process issues, prepares and approves technical documentation, analyzes stability data, drafts specifications, and organizes dossier documentation with analytical and CMC teams. The role works closely with manufacturing, operations, and relevant technical and project teams to transfer new products into industrial production and communicate project status. It also supports regulatory questions and quality audits, maintains laboratory compliance with applicable regulations and company practices, and mentors product development technicians. The position requires compliance with cGMP, GLP, GCP, FDA, and EMA requirements where applicable, along with company SOPs and safety policies.

Requirements

Bachelor of Science in Chemistry, Pharmaceutical Science, Chemical Process Engineering, or a higher degree.
At least 3 years of experience in a pharmaceutical-related field.
Demonstrated mastery of formulation science and/or process development, project management, and work in a GMP/GLP environment.
Ability to maintain data integrity and follow good documentation practices and applicable company and regulatory requirements.

Nice To Haves

Experience in pharmaceutical-related work, with 2 to 5 years described as desired in the posting.

Responsibilities

Develop new pharmaceutical products and optimize existing products in line with the R&D roadmap.
Lead development of animal drug delivery methods, dosage forms, and manufacturing processes for internal and outsourced projects.
Create formulation development plans that establish and support project timelines.
Apply Quality by Design (QbD) and Design of Experiments (DOE) to product and process development.
Plan, execute, and evaluate stability studies for tablets, chews, powders, and liquids at laboratory, pilot, and industrial scales.
Identify and resolve manufacturing process issues and recommend improvements.
Write and approve manufacturing protocols, Master Batch Records, change controls, deviations, and technology transfer reports for scale-up or production batches.
Mentor product development technicians in data collection and analysis.
Compile and analyze stability data.
Draft product specifications and organize dossier documentation in collaboration with analytical and CMC teams.
Collaborate with manufacturing and operations to monitor production and transfer products to industrial production.
Communicate project status, results, and formulation or process development updates to relevant technical and project teams.
Maintain continuous learning by attending industry expos and conferences and applying acquired knowledge.
Maintain compliance with applicable cGMP, GLP, GCP, FDA, and EMA guidelines; address regulatory authority questions and support quality audits.
Ensure data integrity and compliance with company SOPs, policies, specifications, FDA and EMA cGMP regulations, and Virbac safety policy.
Maintain working knowledge of scientific instrumentation, equipment, and methodologies in manufacturing, packaging, and physico-chemical characterization.
Follow good documentation practices (GDP).
Identify and support initiation of deviations, CAPAs, and investigations.
Ensure products are developed on time, according to development plans and applicable regulatory requirements.
Ensure manufacturing processes are mastered for accurate, robust, and repeatable industrial production.
Ensure the R&D formulation laboratory complies with GMP/GDP practices, internal SOPs, and safety policy.