Senior Scientist / Principal Scientist - Formulation R&D at Perrigo

Posted in General Business 14 days ago.

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Location: Grand Rapids, Michigan

Job Description:

Perrigo

Research and Development/Analytical and Formulary • Allegan, Michigan

Lead formulation/process development and commercialization activities (as either an individual contributor or technical leader of junior level scientists) for variety of dosage forms (solid, liquid, semisolid, ophthalmic) using QbD principles.
  • Interfacing with Analytical Research & Development scientists, Technical Operations, RA, QA to facilitate "First-to-File" and "First-to-Market" corporate goals.
  • Lead the manufacture of Pivotal/Registration lots for new products in the Product/Process Development Pilot Plant and Manufacturing facilities. May supervise and mentor team of junior level scientists and technicians in the design and execution of product development activities.
  • Design and perform quality scientific experimentation to develop robust processes in support of Formulation / Process Development activities.
  • Contribute to the development of new experimental approaches. Analyze and defend scientific results from experiments.
  • Generate accurate, reliable data by following established procedures and practices to support product development. Record, tabulate, summarize, interpret, report and publish results. Prepare Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches.
  • Maintain scientific currency. Acts as internal/external Subject Matter Expert (SME) for drug product and process related technical issues and provides technical support to Technical Operations, Manufacturing, Quality and to third party contractors.
  • Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope product/process development and improvement projects.
  • Communicates effectively to project manager and the wider development team and presents data at team meetings and departmental technical meetings.
  • Leads and/or Collaborates with multidisciplinary teams to resolve complex product development issues and respond to internal and external audits.
  • Ensure compliance with current Drug Enforcement Administration (DEA), current Good Manufacturing Practices (cGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies.
Requirements:
  • Knowledge of the principals and practices of pharmaceutical sciences combined with professional experience in developing and testing formulation processes in more than one dosage form or product category.
  • Expert with QbD principles.
  • Expert in writing parts of ANDA submission relevant to the formulation / process development.
  • Sound problem solving skills and good scientific judgment are required.
  • Good communication skills and the ability to work on interdisciplinary teams are required.
  • Hands on small scale equipment and good understanding of large scale conventional pharmaceutical equipment is required.
  • Familiarity with project management methodology is necessary.
  • These skills are acquired through completion of a Bachelor's degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with 6 to 10 years of research experience in the pharmaceutical industry, or a Master's degree combined with 4 to 6 years of relevant research experience, or a doctoral degree combined with up to 2 - 4 year of relevant research experience.


Equal Employment Opportunity/M/F/disability/protected veteran status.

PI101143749



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