Formulation & Process Development Scientist

Virbac•Bridgeton, NJ

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, and to evaluate technologies and formulation processes. The role provides technical expertise in collaboration with other functional groups to develop or optimize products, test new ingredients, and issue material and product specifications. The scientist leads development of new animal drug-delivery methods, dosage forms, and manufacturing processes for internal and outsourced projects. The role includes creating formulation development plans; applying Quality by Design (QbD) and Design of Experiments (DOE); collaborating with global product development teams to prepare, execute, and evaluate stability studies; and working across laboratory, pilot, and industrial scales. Products include solids such as tablets and chews, as well as powders and liquids. The scientist identifies manufacturing-process issues and recommends improvements; prepares and approves manufacturing protocols, Master Batch Records, change controls, deviations, and technology-transfer reports; analyzes stability data; drafts product specifications; and organizes dossier documentation with analytical and CMC teams. The role collaborates with manufacturing and operations on production monitoring and industrial transfers, communicates project status and development results to technical and project teams, mentors product development technicians, supports regulatory-authority questions and quality audits, and maintains applicable regulatory compliance. The position also helps maintain and improve laboratory compliance with GMP/GDP/GCP practices, internal SOPs, and safety requirements. This includes ensuring data integrity, following good documentation practices, maintaining knowledge of relevant scientific instruments and methodologies, and supporting deviations, CAPAs, and investigations.

Requirements

Bachelor’s degree 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 and project management in a GMP/GLP environment.
Ability to work with relevant scientific instrumentation, equipment, and methodologies in manufacturing, packaging, and physicochemical characterization.

Nice To Haves

Experience developing pharmaceutical products at laboratory, pilot, and industrial scales.
Experience with Quality by Design (QbD) and Design of Experiments (DOE).

Responsibilities

Lead and manage development of new animal drug-delivery methods, dosage forms, and manufacturing processes for internal and outsourced projects.
Create formulation development plans to establish and meet project timelines.
Apply Quality by Design (QbD) and Design of Experiments (DOE) to product and process development, controlling critical factors to ensure product quality.
Collaborate with global product development teams to prepare, execute, and evaluate stability studies for dosage forms at laboratory, pilot, and industrial scales.
Identify 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 and guide 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 new products to industrial production.
Communicate project status, results, and formulation or process development information to relevant technical and project teams.
Attend industry expos and conferences and apply 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 used in manufacturing, packaging, and physicochemical characterization.
Adhere to good documentation practices (GDP).
Identify and support initiation of deviations, CAPAs, and investigations.
Help ensure the R&D formulation laboratory complies with GMP/GDP practices, internal SOPs, and safety policy.