Director, 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 SummaryThe position of Director, Technology Management is responsible for administrative management of all activities in support of technology transfer from CPD to API TO and from API TO to CMO’s as well as coordination of logistics and budget aspects in support of API production at CMO’s and of key intermediates of all suppliers for Wyeth. The incumbent will also be responsible, through their subordinates for the overall project management of technology transfer and API TO activities. It is anticipated that the incumbent will directly supervise two staff, one highly technical and another with formal project management experience. The duties include providing coordination of a cross-functional effort for the implementation of technology transfers with, and the effective operational management of, our 3rd party suppliers and contractors. (1) Developing, in conjunction with NP Quality, a detailed process for API TD&T to support the overall Wyeth TD&T process focused on timely delivery of robust processes that assure adequate supply of Products (2) Based on detailed interaction with API TO process groups, preparing a technology package for third-party CMO’s and CRO’s (3) Developing and implementing capacity and supply strategies in support of the needs of API and key intermediates to produce products, (4) Providing technical support to GSS in their identification of third-party CMO’s and CRO’s and in bringing new technologies to Wyeth to improve API Development and Manufacturing (5) In conjunction with CPD, GSS and API TO scientists, determining lifecycle costs of key intermediates and devising improved methods of synthesis to provide value for Wyeth (6) Managing budget aspects of API Technology Ops including accurately projecting anticipated costs of API’s, key intermediates. Note: In contrast to GSS who is responsible for identifying third-party suppliers of API and intermediates and in negotiating costs and supply agreements, this position is responsible for technical aspects of transfers to support GSS Additional responsibilities include liaison with Marketing, Corporate scheduling groups, Project Management, Regulatory Affairs, Research and Development, Engineering, and Quality Assurance. Job ResponsibilitiesAccountable for the management of 3rd Party operational activities during development and validation. Activities include: Assuring timely delivery of key intermediates from CMO’s to support production of API’s at our third-party manufacturers. Providing a detailed technology package to CMO’s and CRO’s. Coordinating activities to assure timely deliveries of API’s, key intermediates and other compounds.Ensuring planning needs are met by communicating requirements and addressing/resolving issues of concern .Overseeing the operations at 3rd Party vendors to ensure production schedules and execution of timely product quality/production performance are being met.Ensuring implementation and execution by subject matter experts on technical/regulatory needs for the projects in support of technical transfer, process changes that affect the program and future product/process and product/process enhancements. This includes coordinating new product/process improvements, validation, trouble-shooting, stability, and raw material issues for new and existing products. Ensuring (in collaboration with cross functional stakeholders such as ES Quality, Environmental Health and Safety (EHS)..) that the 3rd Party vendors operate in quality, compliant and safe environment. Managing the supply aspects of 3rd Party vendors who have contractual licensing arrangements with Wyeth. This includes participating with Business Development in meetings with Licensing Partners for supply related matters. Responsible for technical/ logistical aspects to support Global Strategic Sourcing (GSS) in procuring bulk specialty fine chemicals, intermediates, and custom manufactured compounds for pipeline projects to support API Technology Operations. 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.Developing and maintaining, in conjunction with NP Quality, Regulatory, CPD and other groups, a detailed process for API TD&T to support the overall Wyeth TD&T process focused on timely delivery of robust processes that assure adequate supply of Products. The output would be a handbook containing detailed requirements and templates for API development and manufacturing to support the Wyeth TD&T process of fulfilling deliverables at the various gates. Responsible for the 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. Activities include development and oversight of technology transfer plans to support TT team leader, manufacturing campaign planning, support of GSS in negotiation of business transactions with the contractor, issuance of purchase orders and reconciliation of payment to the contractors, and starting material supply chain management to support the contractor’s work.In conjunction with New Products Quality, responsible for development and implementation of standard operating procedures and templates related to technology transfer in compliance with Wyeth Division Directives and Conformance Standards.Responsible for the 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. This includes coordination of lab activities such as budgeting for chemical and material purchases. Prepares NPPD internal recommendations to VP API Technology Operations.By reviewing the literature, attending meetings with CRO’s and external scientific meetings (DCAT, Informex, Research Meetings and internal project meetings, assure that API TO is aware of new technologies pertaining to API development and production and to coordinate implementation whenever there is a business justification. Basic QualificationsA degree in a scientific discipline relevant to API development, such as Chemistry or Chemical Engineering. Advanced degree preferred. Working in chemistry or related field in a management / administrative role. Knowledgeable of the custom synthesized chemicals industry and trained incurrent Good Manufacturing Practices (cGMP).Knowledge of inventory systems and quality assurance requirements.Minimum of 12 years of relevant experience, including eight years experience in pharmaceutical or related industry; Excellent communication, project management, organizational and computer skills. Demonstrated leadership capabilities. 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       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.