Senior Principal Scientist – Device extractables and biocompatibility - 2406163903W

　　Description

　　Johnson and Johnson Innovative Medicine (JJIM), a member of Johnson & Johnson's Family of Companies, is recruiting for a Principal Scientist, located in Malvern, PA, US or Beerse, Belgium. Remote work options may be considered on a case-by-case basis and if approved by the Company.

　　Patients will always inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science with compassion, we will continue to confidently address the most complex diseases of our time and unlock the potential medicines of tomorrow. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way. Our diverse portfolio spans multiple therapeutic areas in Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We innovate with purpose to lead where medicine is going. Innovation requires thinking differently, so we continue to reimagine the entire research, development and delivery process.

　　Material Sciences is a technical, scientific department within the Therapeutics Development and Supply (TDS) organization. We are expanding our team to strengthen our technical capability around biocompatibility and extractables and leachables (E&L) for devices and drug delivery systems.

　　The Senior Principal Scientist will act as an E&L and biocompatibility Subject Matter Expert (SME) for medical devices and drug delivery systems. Though this is not a laboratory-based role, it will require the close interaction with internal and external laboratories to design the studies and review proposals, protocols and reports.

　　Key Responsibilities:

　　Independently representing Material Science as an E&L and biocompatibility SME, working with other collaborators such as regulatory affairs, analytical testing labs, device SMEs, toxicologists, and consultants, and be a key decision maker for any path forward.

　　Provide technical, strategic, and regulatory leadership to guide the development team on the proper paths forward with consideration of risk, timeline, cost and feasibility based on science, risks, and regulatory feedbacks.

　　Lead the process of Identifying and evaluating contract laboratories for the E&L and chemical characterization of medical devices and delivery systems;

　　Lead the process of designing experiments in support of chemical characterization of medical devices and delivery systems and interpreting data and authoring reports and regulatory responses.

　　Participate in scientific meetings to share knowledge and foster a culture of scientific thinking. Ensure the accurate and timely preparation of technical reports. Provide guidance to other collaborators on any regulatory guidelines.

　　Qualifications

　　Ideally a Ph.D. in chemistry or related life science with 5 years experiences, or B.S/M.S. with 10 years experiences in the medical devices/contract laboratories

　　Strong verbal and written communication skills, ability to communicate effectively cross functions.

　　Intimate knowledge and expertise to design studies of the extractable and leachable and biocompatibility of medical devices and combination devices, especially implanted devices.

　　Ability to demonstrate mastery of principles, practices, and theories in the field of chemical characterization (extractable and leachable testing) and biocompatibility risk assessments.

　　Extensive experiences in medical device industry or device testing laboratories focusing on the biocompatibility and E&L.

　　Must have previous experience interacting with health authorities (such as CDRH) to author responses, support the development regulatory strategies and address regulatory concerns.

　　Expert on all chapters of new ISO-10993, especially part 12 and 18,

　　Expert knowledge on data interpretation of analytical methodologies, such as LC/MS and GC/MS

　　Experience collaborating with contract laboratories is preferred.

　　Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

　　Primary Location Europe/Middle East/Africa-Belgium-Antwerp-Beerse

　　Other Locations NA-US-Pennsylvania

　　Organization Janssen Research & Development, LLC (6084)

　　Travel Yes, 10 % of the Time

　　Job Function Biotherapeutics R&D

　　Req ID: 2406163903W