Manager R&D - Formulation and Process Development
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.
Manager - Formulation and Process Development
The Leader in this position is responsible for working independently on projects and also leading and facilitating formulation and process development and commercialization activities in assigned projects or product categories. This is accomplished by leading project teams and serving as a technical resource for research and development activities to support the company’s First-to-File and First-to-Market strategy.
Major Responsibilities include:
- Lead product/process development and commercialization activities (as either an individual contributor or technical leader of scientists) for new immediate release and modified release solid oral dosage forms (OSDs), liquid oral dosage forms, topical/semi-solids dosage forms and nasal sprays, interfacing with Analytical Research & Development scientists to facilitate “First-to-Market” corporate goals.
- Establish priorities, monitor the progress of all assigned projects, allocate resources, and ensure that projects meet milestones and deadlines for new product development projects.
- Work across multi-departmental/functional and global groups or teams to provide leadership, technical expertise and an enthusiasm to promote an environment of continuous improvement
- Lead the manufacture of Pivotal/Registration lots for new products in the Formulation/Process Development Pilot Plant and Manufacturing facilities.
- Supervise and mentor team of 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 Product Development activities.
- Contribute to the development of new experimental approaches using Quality by Design approaches. Design and conduct stability studies. 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 confirmation 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 Regulatory Affairs.
- Interacts with regulatory agencies, as needed basis.
- Perform effective problems solving, resolution, and implementation of process improvements in designated day-to-day operations and participate in large scope Formulation/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 Good Manufacturing Practices (CGMP), Perrigo policies and Quality Systems, and all applicable regulatory agencies.
- Considerable breadth and depth of problem solving experience is necessary.
- Excellent communication skills and the ability to represent the department to both internal and external constituencies are required.
- The incumbent must possess a: Bachelor’s Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 11+ years relevant pharmaceutical experience, or:
- Master’s Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 9+ years relevant pharmaceutical experience, or:
- Doctorate (PhD) Degree (in Pharmaceutical Sciences, Chemical Engineering or Life Sciences), combined with 7+ years pharmaceutical experience.
- Candidates must have prior supervisory experience, with prior direct line management of a team preferred.
Specialized skills & experiences qualified candidates will include:
- Screening, Milling or Micronizing
- Roller Compaction
- Low or High Shear Wet Granulation
- Fluid Bed Granulation or Coating
- Fluid Bed or Conventional Drying
- Hot Melt Capsule Filling
- Tablet or Capsule Pan Coating
- Low or High Shear Blending
- Capsule Banding
- liquid oral dosage forms
- topical/semi-solids dosage forms
- nasal sprays
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.