Principal Scientist Formulation R&D
Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold. Help us do it.
This role will support key stages of development and commercialization of new or reformulated products through the coordination/execution of internal FR&D processes.
- Lead internal systems (Raw Material Information Management, Ingredient Disclosures) in support of the development and commercialization activities.
- Demonstrated hands-on experience in designing/developing at least two to three different types of dosage forms that include sterile dosage form (Ophthalmic, parenteral), semisolid topical dosage form (cream, ointment. Gel), oral dosage form (liquid, suspension, solid oral), combination drug-device products to facilitate “First-to-File” and “First-to-Market” corporate goals.
- Accomplished as individual contributor or leader of junior level scientists.
- Generate accurate, reliable documentation by following established procedures and practices.
- Prepare appropriate support documentation for experimental, pilot/pivotal, scale-up and process validation batches.
- Work with Development Scientist in supplying critical information in the preparation of Product Development documents for inclusion into the electronic Common Technical Document (eCTD) and Quality Overall Summary (QOS).
- Using lean sigma principles (Green Belt level); perform effective problem solving, resolution, and implementation of process improvements in designated day-to-day operations.
- Participate in large scope product/process development and improvement projects.
- Facilitate the resolution of product development issues related to internal and external processes.
- Established and well known problem solving skills and good scientific judgment,
- Excellent communication/presentation skills and the ability to work on interdisciplinary teams,
- Perrigo Green Belt certification or equivalent accredited Six Sigma Green Belt certification,
- Competent experience in providing innovative solutions by promoting and executing lean sigma principles,
- Advanced knowledge of internal system processes that support the development of all pharmaceutical dosage forms,
- Solid knowledge of the principles and practices of pharmaceutical development in all solid dosage forms,
- Knowledge of current FDA technical initiatives such as SUPAC (Scale Up and Post Approval Changes), cGMPs, compliance and validation,
- Familiarity with project management methodology is necessary,
- Experience in Auditing, FDA Inspections and DEA procedures (preferred).
Education & Experience:
Competencies and skills for position are normally acquired through:
- Completion of a bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with a minimum of 10 years of experience in the pharmaceutical industry, or,
- Completion of a master’s degree in Pharmaceutical Sciences, Chemical Engineering or closely allied life sciences discipline combined with a minimum of 6 years of relevant experience or
- Completion of a PhD degree with a minimum of six years of experience.