Scientist - Formulary 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.
With guidance, the Scientist of Formulary 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.
- 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.
- Lead product/process development, analytical methods development and validation, and commercialization activities as a technical leader for new immediate-release and modified-release solid oral dosage and liquid oral dosage forms to meet corporate goals.
- Lead the manufacture of Pivotal/Registration lots for new products in the Product/Process Development Pilot Plant and Manufacturing facilities.
- Design and supervise or perform quality scientific experimentation to develop robust processes in support 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 and analytical development. Provide technical and review of technical documents, including but not limited to:
- Master Batch Records for Experimental, Pilot/Pivotal, scale-up and process validation batches, Development Report and regulatory documentation
- SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
- 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:
- 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
Technical Knowledge, Skills and Abilities:
- Knowledge of pharmaceutical science and formulation and analytical development methodology used in the pharmaceutical industry is required.
- Capability in design, execution and documentation of robust formulations and scalable manufacturing processes.
- Good communication skills and the ability to represent the department to internal constituencies are required. Familiarity with project management methodology, demonstrated ability to lead project teams and mentor other scientists are required.
- Experience in performing a critical review for technical documents such as API/Excipient/Finished Product supplier technical dossiers (e.g. DMF, technical packages), regulatory (e.g. FDA Guidance and ICH), compendial (e.g. USP and EP), and literature/3rdParty Reports (e.g. CRO Reports).
Supervisory/Leadership Knowledge, Skills and Abilities:
- Position does not supervise.
- 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.