Allergan Sr Mgr, Biocompatibility in Irvine, California
Sr Mgr, Biocompatibility
Irvine, California, United States at https://agn.referrals.selectminds.com/jobs/6226/other-jobs-matching/location-only
▾ ▸ 1 additional location
Bridgewater, New Jersey, United States
Aug 06, 2018Post Date
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients. Power your future & join our bold team.
The Senior Manager, Biocompatibility is a SME related to the biocompatibility and nonclinical safety evaluations of medical devices, biomaterials, tissue products, and combination products as a part of Allergan Device R&D. The position will be responsible for cross-functional and cross-site leadership of biocompatibility activities, including strategy, execution, and support of regulatory submissions, project teams, and manufacturing.
Main Areas of Responsibilities
Organizes, schedules and participates in Biocompatibility Team meetings. Communicates project status to supervisor, project teams, other research managers, and R&D committees as appropriate. Frequent communication is essential and must interface with colleagues in Device Research, Product Development, Regulatory, and Manufacturing.
Responsible for creating detailed Project Plans including scientific strategy and realistic deliverables with timelines for biocompatibility activities across therapeutic areas. Actively involved in the planning, execution and management of biological risk assessments and studies for the safety and biocompatibility characterization of novel and existing products.
Contribute as local SME to the design, execution and interpretation of preclinical safety and biocompatibility evaluation strategies and programs according to relevant regulatory requirements; including biological risk assessments and execution of required studies.
Participate on Product Development Sub Teams as a Biocompatibility representative.
Lead and support the authoring and/or review of documents as required for regulatory registration/submission, regulatory compliance and support of product marketing. Also author/review documents for internal change control processes in coordination with project teams/manufacturing, as needed.
Maintain knowledge of medical device regulations to assure compliance and conformance of programs for evaluation of medical device and other products, including performing gap analysis relevant to changes in biocompatibility standards or guidance.
Strong team leadership skills with demonstrated abilities in biocompatibility related activities.
Experience in a medical device, pharmaceutical, or related setting with a proven record of success in conducting R&D projects.
Experience and working knowledge of medical device, drug and/or biologics and combination product regulations, including ISO 10993
Experience conducting and/or managing outsourced GLP studies
Experience with creating and leading the execution of evidence generation strategies leading to medical device approvals in the US and outside the US
Previous experience with hyaluronic acid, silicone, or tissue-based biomaterials
Strong familiarity with the product development process for medical devices, drug-device combination products, and biologics
Technical report writing proficiency in support of regulatory submissions
Creativity, strong verbal and written communication skills, strong scientific leadership skills, ability to work effectively in independent and team settings, and acute attention to details
Experience training junior staff members
Location flexible between Irvine, CA and Bridgewater, NJ.
Ph.D. and 4+ years of industry experience
Master’s degree and 6+ years of industry experience
Bachelor’s degree and at least 8 years of experience.
Degree in a related scientific or engineering discipline (cell biology, molecular biology, pharmacology, immunology, bioengineering or similar).
Equal Employment Opportunity Employer
Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.