Perrigo is seeking a Senior Principal Scientist in Analytical R&D, a full-time position fo its Allegan location.
The person in this position:
• Designs and provides technical expertise and complex methodologies within AR&D and Scientific Affairs as a whole in support of new product development.
• Leads and trains analytical colleagues in conducting complex experiments as well as introduction, evaluation and application of modern analytical trends/techniques.
• Serves as both an individual collaborative contributor and manages 4-7 scientists/technicians.
• Individually contribute or oversee the creation of new 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 physical and chemical testing on raw material, in-process, finished product and stability samples.This includes documentation and review.
• The successful candidate will 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, patents, 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. This position will 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.
Required Skills • Bachelor degree in Chemistry or Pharmaceutical Sciences, combined with more than 10 years of relevant professional experience, or completion of a master degree in Chemistry or Pharmaceutical Sciences combined with more than 8 years of professional experience, or completion of a doctoral degree in the same fields combined with more than 6 years of relevant professional experience.
• Demonstrated ability to develop and perform critical reviews of a wide variety of technical and scientific documents, including but not limited to drug master files, patents, certificates of analysis, qualification and technical packages for conformance to country-specific scientific documentation requirements, such as USP, FDA submissions or European Pharmacopeia.
• Demonstrated ability to develop and validate complex analytical test methods which are robust and reliable, using a variety of analytical techniques and instrumentation, including but not limited to HPLC, GC, LC/MS, dissolution, UV-Vis and FTIR.
• Demonstrated ability to act as a "go to" individual within AR&D for all analytical issues by providing support to AR&D staff. Excellent communication skills are essential to work effectively in interdisciplinary teams and investigate and resolve technical problems or deviations.
• A thorough working knowledge of cGMP, cGLP, other Regulatory agencies/authorities, and ICH guidance documents is essential. Good leadership skills and demonstrated ability to manage people are essential.
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