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.

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.