Manager, Research Ops

Mgr Research Ops JOB SUMMARY: Responsible for strategy, project planning and implementation of outsourced testing & services to support Vaccine Development. This position will provide supervision, planning and tracking for Development Operation and Outsourcing (DOO). This includes coordination and implementation of plans and schedules at various Development sites and third party testing laboratories for multiple year programs. This will require effective communication and business interactions with third party testing laboratories, PS, AD, CSMD, R&D, QA, GCA, Technical Services, Project Management, TOPS and other support groups at throughout Wyeth. Included in these responsibilities are: organizing regular meetings between Wyeth and the outsource testing laboratory (including agendas and meeting minutes), interacting with QA, Legal and Materials Management to obtain approved service agreements and quality agreements and assuring that DRM is complying with current corporate policies. Personally manage shipment of samples to outsource testing laboratories, when necessary. This position will also be responsible for assisting the department in meeting SCI commitments and in complying with Level I and Level II guidelines.
JOB ACCOUNTABILITIES:
Support Outsource testing to meet Project Timelines and compliance with GMP corporate policies. Coordinate with other Wyeth scientists and the third party testing laboratory to develop, qualify, validate assays and perform routine release and stability testing as necessary to meet project timelines. Work with QA, GCA, TOPS, Legal, Materials Management, Vaccine Development, Project Management and Regulatory to implement third party testing according to Wyeth's corporate policies. This includes but is not limited to obtaining approved Service Agreements and Quality Agreements, Approved Purchase Orders, Global Compliance Audits, Technical audits.
Responsible for development of testing implementation plans, method transfer and site schedules for Major Phase I through Phase III clinical projects for Vaccine Development through interaction with other sites, PD, AD, CSMD, other Development departments, Clinical research, Project Management, Quality and TOPS stake holders. Maintain these plans and advise the management and Project Teams on potential challenges and opportunities.
Manage closure of Laboratory Investigations involving DOO group and those related to third party testing. Provide information and route documents, as appropriate, per the Quality Agreement within Wyeth for investigations initiated at the third party testing laboratory. Follow Vaccine Development SOP's and Quality Agreement to perform laboratory investigations initiated at Wyeth, when appropriate.
Manage tracking of samples and test results performed at third party testing laboratories. Work with appropriate Wyeth laboratories and DOO personnel to assure that the sample tracking system is working effectively and that upper management is informed of any samples that are at risk of delaying project timelines.
Comply with all GMP SOPs and Policies. This includes ensuring that the system used complies with Regulatory and Corporate expectations per the Level I, II and III policies. Ensure appropriate corrective actions plans are prepared and implemented as a result of identified gaps in laboratory operations.
Project leader for assigned projects. This includes managing all of the outsource testing for projects in a GMP compliant manner according to Corporate policies and within project timelines. Keep upper management informed of the project status.
EDUCATION/EXPERIENCE/REQUIREMENTS:
BS, MS, or Ph.D. in the life/physical science (such as Chemistry, Biology, Biochemistry, Microbiology).
BS + at least 9 years, MS + at least 6 years and Ph.D. with minimum of 2 years industrial experience.The incumbent must be people-oriented, able to communicate across disciplines and able to handle multi task/projects. Good organizational and time management skills are also required. The incumbent must have significant background in analytical techniques used for the characterization of macromolecules. He/She must be able to independently or with collaboration with Subject Matter Expert resolve testing-related issues. Must have familiarities with validation of assays as per ICH Guidelines and be familiar with USP/EP/JP applications.This experience could be obtained in the development area of pharmaceutical/biotechnological industry.Wyeth offers competitive compensation and benefits programs including stock
options, child-care subsidies, flex-time, business casual attire,
educational assistance and professional development programs. Please
forward your resume with salary requirements and job reference code to the
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