Sr. Director, Quality Control Services - (Job Number: 0805871)

Sr. Director, Quality Control Services - (Job Number: 0805871) DescriptionCentocor Research and Development, a member of Johnson & Johnson's Family of Companies, is recruiting for a Sr. Director, Quality Control Services, located in Radnor, PA. Centocor Research and Development, develops innovative biomedicines. The world leader in monoclonal antibody production and technology, Centocor has brought critical biologic therapies to patients suffering from debilitating immune disorders. The Sr. Director, Quality Control Services will be responsible for the management and scientific leadership of the Quality Control Services group within the Analytical Development area of BIO Pharmaceutical Development. Provides scientific leadership for approximately 70 scientists within the QC group consistent with corporate and R&D objectives and timelines. This individual will have senior technical responsibilities for the release and stability testing of toxicology, Phase I, II, III clinical and marketed products. In addition this position will have senior responsibility for all Microbiology, Raw Material and Cleaning Validation testing in support of the Spring House Pilot Plant. Senior management and scientific leadership of a cross-site (Raritan, Radnor and Spring House) and diverse group of scientists (M.S. and B.A.) within the QC Services group to maintain and foster an efficient innovative organization with highly skilled personnel and modern technology. Encourage a team based collaborative culture with keen attention to customer needs. Direct and monitor technical programs to insure adherence to cGMP, established timelines, and compliance with regulatory guidelines. May perform other duties as assigned. Specifically, the Sr. Director/Director, Quality Control Services, Analytical Development will have responsibility for carrying out the following with the assistance of staff members:- Drive strategic planning process for QC Services - Serve as senior technical and compliance expert for QC Services- Lead a group of cross-site QC experts responsible for the timely completion of testing- Work with BIOD PD and MPS Senior leadership team to develop outsourcing and external analytical collaboration strategies, as needed-Work with Analytical Development senior leadership to plan and implement strategies for NME release and stability testing- Work with GBSC to harmonize QC practices- Provides support for portfolio reviews, prioritization, metrics, and analyses. -Represent Analytical Development as senior representative on cross-functional R&D committees - Coordinate planning and management of BIO PD and MPS budget. Serve as key link to Finance. - Responsible for the development of all employees within the department by supporting the development of Human Resources Planning (HRP) programs including management development and training to meet current and future business needs. Monitor and oversee optimization of QC processes to support a culture of innovation, best practice, efficiencies, and cycle time reductions, PE. - As a member of the Analytical Development senior leadership team, the candidate will be expected to: Create an environment that values innovation, leadership, scientific excellence, urgency, and personal accountability- Share ownership of the drug process, from NME status through post-product launch support Candidates are required to have a minimum of a B.A. in Chemistry, Biochemistry or Analytical Sciences and10 years pharmaceutical industry experience in managing biopharmaceutical Quality Control laboratories. Prior Quality Control lab management experience is required. Experience managing a large (gt;30) group of QC scientists located in multi QC sites remote to your office is desired. Experience with method validations/qualifications and transfer to QC labs is required. Experience with troubleshooting analytical methods in a QC setting is required. Experience in managing multiple complex projects with shifting priorities and constantly accelerating or changing timelines is required. Prior experience with Regulatory agencies including inspections of laboratories is required. Apply Now