The Method Development Chemist in the Quality Department communicates issues and progress to management regarding formulations, materials, and processes. They are responsible for onboarding new formulations, including mixing and cleaning validations, and supporting existing formulations through change control, quality events, and CAPAs. They work with laboratory personnel on method development, transfer, and validations.

Primary Responsibilities:

Oversee onboarding of new formulations, including raw material reviews, lab batching, specification setting, method validation, and scale-up to production.Investigate quality complaints and out-of-specification events, and monitor corrective and preventive actions.Create and approve Master Manufacturing Batch Records and complete associated change controls.Develop pilot plant capabilities for onboarding and investigative needs.Support validation plans, equipment and process reviews, and develop qualification test plans and protocols.Support CAPA program and ensure completion and response.Create complex reports and attend meetings to communicate updates.Represent the company positively during customer and vendor site visits.Perform method development, transfer, and validation activities for the chemistry lab.Assist with daily chemistry activities and product testing, including GC and HPLC.

Skills & Qualifications:

Knowledge of FDA, ISO 13485, EPA regulations, and customer specifications.Proficiency in Microsoft Office and statistical software (Minitab preferred).Experience with Good Manufacturing Practices, validation of mixing equipment, and chemistry lab skills (GC and HPLC).Strong interpersonal, presentation, and communication skills.Detail-oriented, quick learner, and creative problem solver.Excellent organizational skills and ability to react quickly to unexpected occurrences.Positivity, initiative, self-motivation, and ability to work independently and as part of a team.

Education and Experience:

Bachelor's degree in Engineering or Sciences (Chemistry preferred) and 10+ years' experience in an FDA-regulated Medical Device or Pharmaceutical manufacturing Quality department.Preferred certifications: CQE, CQA, Six Sigma, and/or Lean.

Experience Level:

Expert Level

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.