Senior Technology Scientist I

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 SummaryWith demonstrated ability to function independently and productively, the incumbent is responsible for the development or application of state-of-the-art processes, equipment, control schemes, and standards, process optimization, qualification of alternate raw materials and components, or transfer of production from development or between commercial sites. These projects may have a moderate to high level of technical complexity. Projects may include any or all of the following stages: scope definition, feasibility studies, lab/pilot scale modeling, simulation, cost/benefit analyses, design, specification development, project planning, implementation, and post-implementation monitoring and follow-up. The incumbent must be capable of leading cross-functional projects with some direct involvement from their supervisor. Troubleshoots and resolves moderate to highly complex process issues, diagnosing technical problems and determining short- and long-term solutions. Projects must achieve business, quality, and compliance objectives, and must be executed in a manner that assures full compliance with government regulations and internal company standards and values.Job ResponsibilitiesIdentify opportunities and develop solutions for quality, yield, efficiency, profitability, customer service, or compliance improvements. These also include application of new technologies or techniques to existing processes to ensure that legacy manufacturing processes benefit from advances in manufacturing technology, process upgrades to incorporate new regulatory requirements, and process changes as required to utilize new components or materials. These projects may have a moderate to high level of technical complexity. Define scope of project in consultation with supervisor and stakeholders. Individually or collaboratively through leadership of project team, define alternative solutions, and decision criteria used to evaluate the alternatives. Develop specific plans and prioritize the tasks within the plan to achieve project goals. Transition with project to lead key aspects of implementation efforts. Within projects or as part of system definition across multiple work cells, designs and specifies equipment functional operating requirements. Defines process, material, and product specifications for both control and response variables. Evaluate alternatives or proposed changes through theoretical study, simulation, laboratory testing or other means. Make recommendations on alternative selection.Has and applies considerable knowledge of specific fields or general knowledge across many areas of process technology application. Provides knowledge of manufacturing standards. Develops detailed plans and prioritizes the tasks within the plan to achieve project goals. Lead implementation efforts with complete responsibility for smaller-scope projects or for portions of large projects. With coaching from supervisor, maintains responsibility for application of a technology across more than one project or work cell. Identifies, resolves, and removes systemic limitations and barriers to task completion, or elevates more significant issues to management if necessary. Coordinate collaboration between sites where improvements have synergistic opportunities or where there are requirements for consistency or collaboration. Lead Technology Transfer initiatives when technologies, processes or products are being transferred between commercial manufacturing sites.Leads proactive problem solving efforts for manufacturing processes. Troubleshoots and resolves moderate to highly complex process issues, diagnosing technical problems and determining short- and long-term solutions. Develops and implements methods to systematically evaluate manufacturing process and equipment problems, analyze process data from equipment failures, and make recommendations to prevent recurrences. Works closely with cross-functional groups to resolve system problems to optimize output, minimize contaimination, and minimize cost. Designs modifications to existing process equipment and implement new processes. Works with Manufacturing, QA/QC, Engineering and Technology groups on technical issues and project teams.Collaborate with Development groups during the development of new products to provide a commercial operations perspective to process design and development of new products. Provide input regarding application of technologies that will optimize capital investment to provide robust, productive, and practical processes at commercial scale. Ensure that raw material selection takes into account commercial scale quality, compliance, and financial considerations. The incumbent will also look for opportunities to incorporate Process Analytical Technologies into the process to enhance monitoring and improve control. As part of these responsibilities, the incumbent may prepare documents, order and assemble equipment, or procure raw materials, provide technical support for clinical material production, monitor all aspects of production and summarize outcome of production campaign, including release test results, in technical reports.Promotes cGMP compliance within the workplace by following site cGMP procedures. Incorporate cGMP and regulatory compliance into all assigned projects scope, design and construction work.Basic QualificationsEXPERIENCE IN PROCESS AND PRODUCT VALIDATION, TECH TRANSFER, CHANGES IN FORMULATION, COORDINATING STABILITIES, SOLID DOSAGE FORM.Minimum of B.S. Preferably in Engineering (e.g. Chemical or Industrial), or Natural Sciences (e.g. Microbiology, Biology, or Chemistry) Others (e.g. Business) may be acceptable when supplemented with technical work experience.Training in current Good Manufacturing Practices, and other appropriate sections of the Code of Federal Regulations, regulatory guidance documents and current industry practices for process engineering, validation, bioprocessing, production, or regulatory affairs. The skills and abilities required to perform this job are normally achieved through eight to ten years of industrial or academic experience in regulatory affairs, operations, quality assurance, Technology or development functions as practiced in the Pharmaceutical, Biological, or related field. With an M.S. degree, these skills and abilities are normally developed through six to eight of technical experience. This would normally be the entry level for strong, technically-degreed PhD. graduates. Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills are required.Engineering degree: BS + 8 years; MS + 6 years; PhD + 0 yearsNon-Engr degree: BS + 10 years; MS + 8 years; PharmD + 4 years; PhD + 0 years.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.Minimum Education Required: BachelorYears of Experience Required: More than 5 yearsExpected Travel Time: None Zip Code :US-PR-Guayama Leading the way to a healthier world.