Program Manager, API Technology Management

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 SummaryReporting to the Director of Technology Management, is responsible for assisting with the management of the resources to support API Technology Operations, including all operational activities during the API late development phase related to domestic/international third party suppliers. In particular, is responsible for developing cost estimates of key intermediates and small molecule New Molecular Entities (NME’s) based on internal development work to support Global Strategic Sourcing (GSS) in their negotiations with 3rd party manufacturers. Also responsible for coordinating all aspects of outsourced activities pertaining to the preparation of reference standards, impurities, metabolites, and other compounds to support late development activities and manufacturing. Supports GSS with technical input on 3rd party suppliers of API and intermediates in order to make informed supplier selection. In conjunction with New Products Quality, provides documentation support for API TO in order to assure compliance with cGMP including development of SOP’s for training, technology transfer, etc. Assists the Director in tracking of expenditures and managing the API TO budget for internal development activities as well as those of 3rd party suppliers. Additional responsibilities include liaison with Marketing, Corporate scheduling groups, Project Management, Regulatory Affairs, Research and Development, Engineering, and Quality Assurance.Job ResponsibilitiesProvides Cost Estimates for API’s for NME’s and key intermediates at third-party suppliers. For NME’s, based on in depth interaction with project chemists and knowledge of third party cost structures, determines cost of API’s to assist GSS in negotiations with suppliers. Based on detailed literature searches and knowledge of synthetic process chemistry, determines cost effective routes for key intermediates and proposed alternative routes in order to provide lowest possible cost intermediates. Where alternatives are possible, works with API TO chemists and engineers in conducting process research studies toward implementing a lower cost route.Responsible for technical/ logistical aspects to support Global Strategic Sourcing (GSS) in procuring bulk specialty fine chemicals, intermediates, and for coordinating preparation of reference standards, impurities, metabolites for pipeline and commercial projects to support API Technology Operations. Activities include representing NPPD as it interacts with other functional groups (quality, CPD, regulatory, GSS) in the selection process for suppliers of materials and API’s. This may include participating, as appropriate in GSS meetings with domestic and international chemical suppliers to ensure NPPD interests and objectives are met. Participates in the multidisciplinary team supplier selection effort led by Global Strategic Sourcing, whose objective it is to identify the bulk active pharmaceutical ingredient manufacturer for the development / commercial supply of a New Chemical Entity. This includes supporting the evaluation of potential key third party manufacturers, transferring technical data, contributing to the preparation of a recommendation document, and supporting Global Strategic Sourcing’s negotiation of contracts. Assist the Director with project management for technology transfer of active pharmaceutical ingredients to contract manufacturers as well as developing project timelines for process modifications and technical support for API’s used for commercial products. Assist with development and implementation of standard operating procedures and templates related to technology transfer and validation in compliance with Wyeth Division Directives and Conformance Standards and in support of the TD&T process. Responsible for documentation tracking and management for API TO. Responsible for supporting the Director in coordination of the administrative operations related to API Technology Operations. This includes the participation in the annual budget submission process and monthly reporting of commitments to the budget. Support coordination of lab activities such as budgeting for chemical and material purchases for API Technology Operations.Basic QualificationsA degree in a scientific discipline relevant to API development, such as Chemistry or Chemical Engineering. Advanced degree preferred with a PhD in organic chemistry. Ability to conduct and interpret detailed literature searches with tools such as SciFinder, Beilstein, etc. Working in chemistry or related field in a management / administrative role. Knowledgeable of the custom synthesized chemicals industry and trained in current Good Manufacturing Practices (cGMP) and documentation management . Knowledge of inventory systems and quality assurance requirements. Minimum of six years experience in pharmaceutical industry. Excellent communication, project management, organizational and computer skills. Detailed knowledge of organic process development and route selection.Position 22004Relocation 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       www.wyeth.com/careers Wyeth is an equal opportunity employer that shares the vision of a diverse workplace. 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.