Senior Product Engineer -Animal Safety

Job Summary:

Leads technical projects supporting maintenance, improvement, and lifecycle management of Animal Healthcare products, including veterinary pharmaceuticals, nutritional supplements, feed additives, probiotics, wellness products, and related technologies. Serves as a technical subject matter expert responsible for improving product performance, reliability, manufacturability, quality, cost, and regulatory compliance. Apply expertise in chemistry, medicinal chemistry, formulation science, veterinary applications, and product performance to solve complex technical challenges. Works collaboratively with Research and Development, Quality, Regulatory Affairs, Operations, Supply Chain, Technical Services, and Commercial teams to deliver scientifically sound and commercially viable solutions.

Essential Duties and Responsibilities:

• Design and conduct experimental testing to evaluate product performance, stability, quality, and manufacturability throughout the product lifecycle.
• Lead technical investigations and troubleshooting activities for commercialized and ongoing operations for Animal Health products.
• Develop and implement product and process improvements to enhance quality, reliability, customer satisfaction, manufacturing efficiency, and cost performance.
• Lead technical projects associated with formulation changes, raw material changes, manufacturing transfers, supplier qualifications, and continuous improvement efforts.
• Support development, scale-up, validation, and commercialization activities associated with new products, line extensions, and reformulations.
• Evaluate product performance using laboratory studies, stability programs, analytical data, customer feedback, and field observations.
• Apply scientific principles to improve product shelf life, ingredient compatibility, bioavailability, palatability, and overall product performance.
• Author and review technical reports, protocols, specifications, risk assessments, validation documents, experimental records, and Standard Operating Procedures.
• Investigate product failures, customer complaints, deviations, nonconformances, and corrective and preventive action activities to identify root causes and implement sustainable corrective actions.
• Collaborate with veterinary, regulatory, quality, and operational teams to ensure compliance with applicable regulations, quality standards, and product claims.
• Use statistical tools, Design of Experiments, risk assessment methods, and data analysis techniques to support technical decisions.
• Maintain technical expertise regarding scientific developments, regulatory expectations, and emerging technologies relevant to animal health products.
• Provide technical guidance and coaching to technical employees on assigned projects, as needed.

Skills and Competencies:

Cultural Savvy: Demonstrates and lives One Neogen Pillars of Trust: Openness, Honesty, Credibility, Respect, and Service through actions, behaviors, and communication.

Communication: Communicates complex scientific information effectively to technical and nontechnical stakeholders and actively listens to others.

Technical Expertise: Applies chemistry, biochemistry, formulation science, analytical science, and veterinary product knowledge to product and process challenges.

Decision Making and Problem Solving: Identifies information needed, evaluates technical risk, determines root cause, and makes timely, data-driven decisions.

Project Leadership: Independently leads cross-functional technical projects, establishes clear plans, and drives execution through completion.

Driving Performance: Maintains focus, meets productivity and quality standards, identifies improvement opportunities, and escalates barriers appropriately.

Organizational Strategy: Understands how technical activities support Animal Health customers, product performance, supply continuity, compliance, and business objectives.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill, and ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and Experience

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biological Sciences, Animal Science, or a related scientific discipline with a minimum of eight years of relevant industry experience; or a master’s degree in a relevant scientific discipline with a minimum of six years of relevant industry experience; or a PhD in a relevant scientific discipline with a minimum of three years of relevant industry experience.

Required Qualifications:

• Strong foundation in chemistry, formulation science, analytical science, biochemistry, or a related applied scientific discipline.
• Experience with animal health products, veterinary pharmaceuticals, companion animal products, livestock health products, feed additives, animal nutritional supplements, probiotics, nutraceuticals, or veterinary diagnostics.
• Ability to design experiments, analyze results, and make data-driven technical recommendations.
• Experience authoring and maintaining technical reports, protocols, specifications, validation documents, risk assessments, and Standard Operating Procedures.
• Working knowledge of statistical analysis, Design of Experiments, root cause analysis, and continuous improvement methodologies.
• Strong project management, organizational, and communication skills with the ability to manage multiple priorities.
• Experience working within cGMP, such as 21 CFR parts 210 and 211, GMP, ISO, or another regulated quality system.
• Knowledge of FDA Center for Veterinary Medicine (CVM) regulations and expectations, Guidance for Industry (GFI) documents, VICH guidance, veterinary pharmaceutical regulations, animal feed requirements, or applicable animal health supplement regulations.
• Ability to collaborate effectively with Research and Development, Manufacturing, Quality, Regulatory Affairs, Supply Chain, Technical Services, and Commercial teams.

Preferred Qualifications:

Experience in one or more of the following areas is preferred:

• Formulation development and optimization, stability studies, shelf-life assessment, product scale-up, technology transfer, pharmaceutical or nutritional product development, or ingredient compatibility and performance evaluation.
• Experience supporting commercial manufacturing process, process validation, equipment qualification, process optimization, technology transfer, deviation investigations, CAPA implementation, and lifecycle management of veterinary pharmaceutical or animal health products.
• Medicinal chemistry, pharmaceutical sciences, veterinary pharmacology, toxicology, drug metabolism and pharmacokinetics, veterinary medicine, or nutritional chemistry.
• Experience supporting product registrations, NADA/ANADA submissions, regulatory submissions, claims substantiation, or post-approval product changes.
• Six Sigma Green Belt or higher, Lean certification, or equivalent continuous improvement training.
• Demonstrated success implementing quality, cost, service, reliability, or efficiency improvements.

Language Skills:

Ability to read, interpret, and understand safety rules, operating and maintenance instructions, procedural documents, technical literature, and regulatory requirements in English. Ability to communicate technical information clearly in written and verbal formats.

Mathematical Skills:

Ability to perform college-level mathematical operations and apply basic statistical functions, data trending, experimental design, and interpretation of scientific results.

Computer Skills:

Solid knowledge of computers and operating systems, electronic communication, data analysis tools, and Microsoft Office applications. Experience with electronic laboratory notebooks, quality systems, statistical software, or product lifecycle systems is preferred.

Physical Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Work may include office, laboratory, pilot, and manufacturing environments. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation: The anticipated salary range for this position is $100,000-$120,000 annually, with additional bonus opportunities. Actual starting compensation will be determined based on factors including the selected candidate’s relevant experience, qualifications, level of responsibility, and the scope of work associated with the position.