Sr. Director, Bioassay Methods Development - (Job Number: 0805874)

Sr. Director, Bioassay Methods Development - (Job Number: 0805874) DescriptionCentocor Research and Development, a member of Johnson && Johnson's Family of Companies, is recruiting for a Sr. Director, Bioassay Methods Development, 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, Bioassay Methods Development will be responsible for the management and scientific leadership of Bioassay Methods Development group within the Analytical Development area of BIO Pharmaceutical Development. Provides scientific leadership for approximately 40 scientists within Analytical Development group consistent with corporate and R&&D objectives and timelines. This individual will have senior technical responsibilities for the development, validation and transfer of all bioassay and immunoassay methods used in the analysis of drug substance and drug product methods. In addition, this position will be responsible for providing all bioassay and immunoassay support to purification, cell culture and formulation development as well QC and Operations groups at the GBSC manufacturing sites as necessary for new molecular entities and marketed products. Senior management and scientific leadership of a diverse group of scientists (Ph.D., M.S. and B.A.) within the Analytical Development 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. Balance rapid method development with the long-range development and new technology. May perform other duties as assigned. Specifically, the Director, Bioassay Methods Development, Analytical Development will have responsibility the carrying out the following with the assistance of staff members:- Drive strategic planning process for all Bioassay && Immunoassay Methods including test services for clinical and contract commercial products-Serve as the senior technical expert for bioassay and immunoassay development projects-Lead group of bioassay technical experts- Work with BIOD PD and MPS Senior leadership team to develop outsourcing and external bioassay collaboration strategies-Work with Discovery Research to plan and implement strategies for NME transitions from early to late stage- Work with GBSC to plan and implement transfer and technical support strategies - 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 R&&D 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 Ph.D. in Biology, Biochemistry or related discipline and at least 10 years pharmaceutical industry experience in biopharmaceutical bioassay and immunoassay release/stability methods development. Experience managing a large (>30) group of scientists and managing development scientists located in multi sites remote to your office is desired.. Experience with method validations and transfer to QC labs is required. Experience with troubleshooting analytical methods in a QC setting and developing improved methods is required. Experience in managing multiple complex projects with shifting priorities and constantly accelerating or changing timelines is necessary. Experience with Regulatory agencies including approval of commercial biopharmaceutical products is required. Apply Now