Formulation & Process Development Senior Scientist

Location: Bridgeton

Experiencing together a unique human adventure

Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution. Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams.

We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives. Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business.

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 and accurate, robust, repeatable processes are developed in a timely manner, in agreement with the development plan, and in adherence to applicable regulation requirements.

Area of responsibility 2:
Mentor the junior formulation scientists as needed, foster a culture of excellence and collaboration to maintain optimal throughput and productivity Main activities

• 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.

Expected results

Provide guidance to the juniors scientists to achieve the desired project scientific outcomes

Area of responsibility 3:
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.
• 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
• 5+ 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.

#J-18808-Ljbffr