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Virbac · 4 months ago

Formulation & Process Development Scientist

Bridgeton MO, USA

Full-time

Onsite

Mid Level

3+ years exp

Virbac is an animal health pharmaceutical company specializing in products for companion animals. They are seeking a Formulation & Process Development Scientist to develop and optimize pharmaceutical products, collaborating with various teams to ensure compliance and quality in the product development process.

Animal FeedPharmaceutical

Responsibilities

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

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

Adhere to overall good documentation practices (GDP)

Identify and support initiation of Deviations, CAPAs and Investigations

Qualification

Formulation scienceProcess developmentGMP/GLP complianceProject managementPharmaceutical scienceChemical engineeringData analysisTeam collaborationProblem-solvingContinuous learning