Senior Scientist, Reference Material and Critical Reagents - 2306154922W

　　Description

　　Janssen Research & Development, L.L.C., a division of Johnson & Johnson’s Family of Companies is recruiting for a Senior Scientist, Reference Material and Critical Reagents located in Malvern, PA.

　　At Janssen, we never stop working toward a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, and you can count on us to keep working tirelessly to make that future a reality for patients everywhere, by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Arterial Hypertension. Visit us: www.janssen.com (https://jnjc.taleo.net/enterprise/www.janssen.com) .

　　The Senior Scientist will be part of the dynamic Process Analytical Sciences (PAS)-Reference Material and Critical Reagents (RMCR) team within Analytical Development (AD), BioTherapeutics Development & Supply (BTDS), with a specific focus on the storage and distribution, preparation, qualification, requalification, and lifecycle management of reference materials (RMs) and critical reagents (CRs). The Senior Scientist will be highly challenged in a fast paced, global, GMP environment supporting multiple large molecule and cell & gene therapy programs. The Senior Scientist will work in a team environment, as well as contribute individually to meet accelerated timelines for project goals.

　　Responsibilities of the Senior Scientist will include, but are not limited to, serving as the point of contact to contractors and customer groups (site QC labs, AD labs, and in-country testing labs), coordinating preparation of reference materials and critical reagents as required by project need or inventory, reviewing and managing inventories by approval of requests from customers, as well as coordinating qualification and requalification of materials and issuing the appropriate documentation.

　　Key Responsibilities:

　　Maintain qualification and requalification schedules for RMs/CRs and work with sites to acquire the data necessary to prepare qualification and requalification documents and issue Certificate of Analysis.

　　Collaborate and coordinate with sites and analytical testing labs to ensure testing needed to support RMCR activities meets accelerated project timelines.

　　Work with sites and statisticians to compile trending data as appropriate for reference materials.

　　Author SOPs, protocols, and specifications to support project needs.

　　Drive strategy of RMs and CRs for new modalities as well as refine those that are already established to ensure alignment with Health Authority expectations.

　　Perform analytical testing as needed as part of reagent preparation and qualification.

　　Follow general laboratory safety procedures.

　　Attend AD sub-teams and cross-functional project meetings as representative for RMCR.

　　Prepare and coordinate appropriate RMs and CRs.

　　Drive continuous improvement initiatives for RMCR processes.

　　Work in an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability.

　　Builds strong collaborations and focuses attention to customer needs.

　　Prepare regulatory filing sections and make presentations at AD governance and for other cross functional teams.

　　Collaborate to drive RMCR strategies for early, late development, and commercial portfolio.

　　Provide training and mentoring to junior staff.

　　Qualifications

　　Education:

　　Ph.D. in Chemistry, Biochemistry, or a related field with at least 5 years OR M.S. with at least 10 years OR B.S. with at least 15 years of relevant industry experience is required.Experience and Skills:

　　Required:

　　Proven ability to creatively solve technical problems while meeting accelerated project timelines is required.

　　Highly organized to plan, implement, and document work with limited guidance is required.

　　Capability of working in a cross-functional team environment with a positive attitude is required.

　　Proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook, and OneNote) is required.

　　Strong technical writing experience (SOPs, protocols, and qualification reports) is required.

　　Proven ability to lead multiple projects simultaneously and to collaborate with multiple sites to ensure timely completion of activities is required.

　　Highly self-motivated and eager to learn.

　　Excellent communication skills (written, oral, and presentation) are required.

　　Solid understanding of release and stability testing of large molecules is required.

　　Excellent accuracy and strong attention to detail when reporting data within documents is required.

　　Ability to implement procedures and processes and to present findings to management is required.

　　Preferred:

　　Protein chemistry experience with HPLC, ELISA, Bioassay, Capillary Electrophoresis, Characterization, and cIEF is preferred.

　　Experience with reference material and critical reagent sourcing, qualification, and management is preferred.

　　Knowledge of cGMP regulations, FDA guidance, and process excellence methodology is preferred.

　　Experience with Document Management Systems (i.e., TruVault, Documentum) is preferred.

　　Experience with LIMS is preferred.

　　Basic understanding of data trending and experience with statistical software applications (i.e., JMP, Minitab) is preferred.

　　Experience writing regulatory filings is preferred.

　　Experience as a direct line manager is preferred.

　　Other:

　　Focus on achievement and delivery of results with high sense of urgency.

　　No travel required.

　　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.

　　For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit www.careers.jnj.com .

　　Primary Location NA-US-Pennsylvania-Malvern

　　Organization Janssen Research & Development, LLC (6084)

　　Job Function Biotherapeutics R&D

　　Req ID: 2306154922W