Scientist / Sr. Scientist - Formulary R&D

Research and Development/Analytical and Formulary Allegan, Michigan


Descripción

With guidance, the Scientist of Formulation R&D will provide support of development and commercialization activities to US Consumer Selfcare - Americas R&D for new or reformulated Generic over-the-counter (OTC) ANDA pharmaceutical, NDA 505(b) (2) and OTC Monograph products meeting the company’s First-to-File and First-to-Market strategy at a global level (U.S., Mexico & India).

The Scientist will also properly assimilate principles of Perrigo’s Positive Workplace Policies and Code of Conduct by demonstrating and reinforcing appropriate behaviors that foster a workplace of trust, commitment, and accountability while striving towards results.

Responsibilities: 

  • Strategy deployment (Collaborative development of business and behavioral result targets that align with segment and corporate objectives.
  • Communication (Develop systems to assure effective cascade of business information)
  • Leader Visual Management (Develop system to assure effective visibility of metrics that enable next levels to develop daily management systems that support overall strategy)
  • Use team, department and organizational metrics to drive improvement in quality and throughput of products and knowledge.
  • 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.
  • Design and perform quality scientific experimentation to develop robust processes in support of Formulation / Process Development activities. Design and execution of product 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.
  • 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.
  • Ensure compliance of all formulation activities to applicable cGMPs, cGLPs, any specific regulatory guideline, and company SOPs on a consistent basis.  Conduct routine laboratory audits and involvement in activities associated with third party laboratory audits, as required. 

Knowledge, Experience and Education Qualifications:

  • Bachelor’s Degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline with 4 or more years of relevant experience -- or
  • Master’s Degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline with 2 or more years of relevant experience – or
  • A Ph.D in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline

Leadership Knowledge, Skills and Abilities: (NOTE: This position does not directly supervise others)

  • Ability to align with clear goals, direction, motivation, clarity, and support needed for self and others to excel in a continuous improvement culture.
  • Ability to organize appropriately in an environment requiring strict adherence to timelines.
  • Use the appropriate amount of analysis, experience and judgement to make clear/concise decisions.
  • Good communication skills including strong verbal and interpersonal skills to lead and influence.