Formulation & Process Development Senior Scientist

Virbac•Bridgeton, MO

About The Position

The Formulation & Process Development Senior Scientist develops new and optimized existing pharmaceutical products for the animal health market. Identify and evaluate new technologies and/or formulation processes. Provide technical expertise in collaboration with other functional groups to prepare formulations development plans, to help establish and meet project timelines, prepare laboratory, pilot, and industrial scale batches, and support technology transfer to Industrial operations, for a variety of product dosage forms including, tablets, liquids, powders, chews and others, in compliance with cGMP, FDA and EMA regulations/guidelines. Mentor the Junior Formulation Scientists.

Requirements

BS in Chemistry, Pharmaceutical Science, Chemical Process Engineer or higher degree.
5+ years of experience in a pharmaceutical-related field is desired.
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.

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.
Mentor the junior formulation scientists as needed, foster a culture of excellence and collaboration to maintain optimal throughput and productivity.
Actively demonstrate expert level knowledge and skills, in design of experiments, industrial manufacturing, packaging and technology transfer.
Mentor the junior scientists and expand their knowledge and technical skills.
Assist the junior scientists with documentation, preparing and reviewing documentation.
Assist the junior scientists with implementation of new technologies and the associated instrumentation.
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.