What are the responsibilities and job description for the Senior Scientist position at Perrigo?
At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All . We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone , we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, ACO®, and many more. We Are Perrigo . We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.
Join us on our One Perrigo journey as we evolve to a blended-branded business to win in self-care.
Description Overview
Applies technical expertise and complex methodologies to conduct and / or design experiments in support of product formulation and regulatory submission. Provides scientific and technical support to existing drug products in a cross-functional team setting, primarily MRB (material review board). Leads and trains analytical colleagues in conducting complex experiments as well as introduction of modern analytical trends / techniques. Serves as both an individual collaborative contributor and manages 2-5 scientists / technicians.
Scope of the Role
- Support the qualification of raw material supplier changes and alternate sources for use in existing finished products by conducting / overseeing analytical assessments, method development, and method validation to ensure product compliance.
- Individually contribute or oversee the creation of product specifications and test methods which are robust and meet regulatory requirements. Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments, provide data and provide responses to comments on FDA deficiency letters.
- Perform or oversee physical and chemical testing on raw material, in-process, finished product and stability samples. This includes documentation and review.
- Individually investigate or lead investigations to successfully resolve analytical problems, project issues and deviations. Accurately maintain all related documentation in compliance with SOPs.
- Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
- Attend and present data at project-related meetings, interact with other departments and outside testing laboratories to ensure proper analytical testing. Participate in cross-functional project teams, and exercise and build basic team effectiveness skills.
- Develop, supervise, and evaluate performance of team members. This includes providing technical and procedural training and mentoring for team members and coordinating team member activities to successfully accomplish departmental goals.
- Conduct technical document review for external departments. Approve analytical reports, CofA, specifications, test methods and deviations related to own or other projects.
- Individually contribute or oversee the development, validation and transfer activities associated with non-complex to complex analytical methods.
Experience Required
Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.
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We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here
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We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo