AVP, Analytical & Formulation Development

Job Category: Biotech/R&D/Science Job Description:At Wyeth, we have a vision of leading the way to a healthier world. We've committed ourselves to achieving this vision by making quality, integrity and excellence the hallmarks of our business. A Fortune 500 company and global leader in pharmaceuticals, consumer healthcare, and animal healthcare products, we know that our employees are who keep us on the cutting edge of innovative discoveries and superior customer service. To sustain and enhance our leadership position in the pharmaceutical industry, we continue to recruit, develop and motivate individuals whose skills, values, and work ethic will grow and improve our business. Job SummaryDirect all activities related to the development, qualification, validation, and transfer of analytical procedures to support global registration of new products. Provide reagents and reference standards to global QC testing labs. Implement and assure compliance with cGMP, corporate/division and other regulatory guidelines for product testing and release. Implement and monitor programs to well-characterize conjugate and other vaccine antigens and formulated vaccine products to fulfill anticipated regulatory requirements. Develop strategies and tactical plans for maximizing productivity of the Analytical Group, and ensure that the appropriate capability and capacity are in place for viral (Pearl River) and Bacterial (Sanford) platforms.Job ResponsibilitiesDirect Analytical Development groups in Sanford/RTP and Pearl River for the development, qualification, validation and transfer of assays to support registration of new vaccines including bacterial, viral and other antigens. In conjunction with the leaders/scientists of Discovery Research, Process Development, Regulatory and Project Management groups, determine the nature of assays to be developed and ensure that the appropriate assays are developed and qualified/validated by the Analytical Development personnel. Ensure that in process and release testing is appropriately performed on clinical trial material.Direct Formulation Development groups in Sanford/RTP and Pearl River for the development of vaccine candidate formulations.Ensure that all project deliverables for Analytical & Formulation are clearly defined and appropriately defined in the Department’s Scorecard. Ensure that there are appropriate human and facility resources (both capacity and capability) to deliver the objectives. Ensure that senior management is aware of the impact of new assignments and trade offs are coordinated across functional areas.Ensure technical excellence within Analytical & Formulation Development. Influence technical excellence within Development, Discovery and Manufacturing. Influence within and outside Wyeth with respect to technical issues impacting vaccines and therapeutic proteins. Ensure that senior technical staff has program reviews at least annually. Ensure seniors are attending and contributing to professional meetings.Manage budget, personnel and other administrative duties: Prepare annual budget for the Analytical development group. Monitor expenses on a monthly basis to keep within overall budget. Maintain organizational chart. Prepare timely performance planning and review documents for direct reports. Regular review of lab safety of personnel.cGMP Compliance: Participate in WLV level II guideline and level 3 procedures for assay qualification, validation and transfer. Enforce strict adherence to policies and guidelines for CTM testing procedures. Ultimately responsible for maintaining the highest level of compliance through regular review/audits of laboratory practices and training of laboratory and administrative personnelBasic QualificationsPh.D. Chemistry, Biochemistry or related discipline with 10 or more years of related experience.Familiarity with carbohydrate chemistry, protein chemistry, bacteriology, virology, and statistics.CGMP and cGLP regulations. Prior management experience. Independent research training requiring the analysis and interpretation of data and scientific judgment.A minimum of 10 years of product development and/or assay development experience is needed.Significant experience in quality control and regulatory, with experience in closing out either 483’s or consent decree issuesExperience in well define biologicals, with a working knowledge of proteomics.Successful record in supervising the development of comprehensive analytical procedures.Relocation is not available for this position.Wyeth offers competitive compensation and benefits programs, including child-care subsidies, flex-time, business casual attire, educational assistance and professional development programs.For more information and to apply online, please visit us at: www.wyeth.com/careers Wyeth is an Equal Opportunity Employer, M/F/D/V. Search Firm Representatives: Please Read Carefully. Wyeth is not seeking assistance or accepting unsolicited resumes from search firms for this employment opportunity. Regardless of past practice, all resumes submitted by search firms to any employee at Wyeth via-email, the Internet or directly to hiring managers at Wyeth in any form without a valid written search agreement in place for that position will be deemed the sole property of Wyeth, and no fee will be paid in the event the candidate is hired by Wyeth as a result of the referral or through other means. Note: Any search agreement entered into with Wyeth prior to January 2004 is hereinafter void.Search firms are essential to the recruitment and staffing efforts at Wyeth and we value the partnerships we have built with our preferred vendors. For this reason, Wyeth has established and regularly maintains a preferred vendor list. Please note that even preferred vendors need to have a written search agreement signed by the Vice President, Strategic Staffing at Wyeth in place for the specific position in order for a fee to be paid for any candidate referrals.Job Experience:See above.Expected Travel Time: None Zip Code :US-NC-Sanford Leading the way to a healthier world.