Manager R&D, Rx Strategic Partnerships
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.
Position provides technical expertise and support to drug development programs executed by Strategic Partnership companies. The role assures Perrigo technical input into all aspects of drug development, FDA regulatory submissions and commercial product launch.
As a result of the job responsibilities, this role may sit at a Perrigo site location or be remote, depending on the selected candidates qualifications and circumstances.
Core Job Knowledge:
- Demonstrated hands-on experience in designing/developing at least two to three different types of dosage forms that include transdermal patches, metered-dose and dry powder inhalers, modified-release oral solids, and sterile dosage forms (ophthalmic solutions and suspensions, lyophilized injectables, pre-filled syringes and long-acting injectables), combination drug-device products.
- Hands-on experience in formulation/analytical development by quality-by design, scale-up and technical-transfer, process validation for the complex generics.
- Experience in working with CMOs and partnership companies in developing complex generics
- Ability to critically evaluate data, identify trends and draw accurate conclusions.
- Able to work through complex problems with a systematic approach.
- Competency in managing project milestones and timelines.
- Knowledgeable in FDA regulatory processes and ANDA data requirements.
- Strong interpersonal communication skills and well-developed collaborative management skills.
- Ability to work effectively across various drug development disciplines.
- Excellent writing skills in both technical and business writing.
Education and Experience:
- Minimum B.S. degree in a scientific discipline and 8+ years of pharma industry experience.
- Collaborate with partnership companies and CMOs to establish product development strategies, scale-up, data expectations for FDA submissions, develop project timelines / milestones and commercial launch planning.
- Provide recommendations for pilot, exhibit, bio, scale-up batch and process validation strategies that satisfy all bioequivalence, submission and commercial launch requirements
- Technical review of product development reports, product characterization data, batch records, process optimization and validation reports.
- Propose solutions to unexpected product formulation, manufacture and testing issues.
- Perform on-site visits to partner manufacturing facilities to audit data and records
- Research and review technical literature e.g., summary basis of approval, Drug Master Files, related FDA guidance, applicable patents, bench-marking technologies, etc.
- Draft and edit technical responses to FDA review questions and meeting packages
- Support due diligence assessments on new partnership opportunities for the Rx business