Technology Transfer Scientist Job in Andover, Massachusetts US

Technology Transfer Scientist

Org Marketing Statement Pfizer Inc: Working together for a healthier world Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide. Role Description The Technology Transfer Scientist position in the Andover Technical Services group will use his/her technical understanding of biologics manufacturing processes to facilitate tech transfer and process validation/project management activities. The projects to be supported by the incumbent include technology transfers for the manufacturing of early to late phase clinical trial materials, and the transfer of commercial manufacturing between manufacturing facilities (including internal, partner, and contract manufacturing sites). The incumbent is expected to lead cross functional teams which oversee and facilitate the process transfer and process change lifecycle. The incumbent will also work with the appropriate governance to establish process validation plan and methodology, and coordinate with internal and external support functions for the execution of process validation at the site. Responsibilities "Responsible for the oversight and facilitation of all aspects of a drug substance process transfer lifecycle while maintaining project management timelines and prioritizing critical tasks to achieve project goals "Lead cross-functional teams in technology transfers from development labs to large-scale mammalian-cell based manufacturing or between manufacturing suites or sites. "Develop technology transfer strategy and plan for large scale process development project, clinical drug substance manufacturing, commercial drug substance manufacturing, and process validation campaigns "Develop process validation strategy in conjunction with cross-site technology transfer governance including authoring documentation associated with process validation such as process validation plans, protocols, and reports "Provide project management oversight on technology transfer projects and major process change initiatives; coordinate project activities, deliverables, and site commitment with internal and external stake holders "Lead regular tech transfer team meetings for cGMP processes that vary in phase, scope and complexity "Author relevant sections of CMC regulatory filings and associated supporting documentation "Create detailed Bill of Materials, collaborating with Supply Chain to ensure proposed campaign materials meet compendia, financial, and timeline requirements "Proactively identify challenges and manage their resolution by use of the candidates technical and process understanding to identify appropriate stakeholders to participate in targeted sub-teams "Participate in relevant project, site and network governance as required "Create and maintain a program capturing and retaining detailed process knowledge for commercial products manufactured at the site "Support annual product review and process monitoring "Develop best practice for technology transfer and process knowledge management Qualifications "BS in Science or Chemical Engineering with 5+ years of experience or an MS with 3+ years. Level and title will by commensurate with candidate's experience. "The ideal candidate should possess extensive experience in biologics manufacturing process development or production operations including knowledge of cell culture and purification. "Demonstrated strong communication skills and technical writing skills as well as the ability to effectively create and lead teams are required. Equal Employment Opportunity Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Pfizer in the U.S. In certain circumstances it may be advantageous to Pfizer to support the application(s) for temporary visa classification and/or sponsor applications for permanent residence so that a foreign national colleague can accept or remain in a work assignment in the U. S. For certain classes of temporary visas, the resulting work authorization may be specific to Pfizer and the specific job and/or work site. Pfizer may at its business discretion decide to or refrain from obtaining, maintaining and/or extending the temporary visa status and/or sponsoring a colleague for permanent residency and /or employment eligibility, considering factors such as availability of qualified U.S. workers and the colleague's long-term prospects for securing lawful permanent residence, among other reasons. Employment applicants requiring immigration sponsorship must disclose, when initial application for employment is made, whether or not they are legally authorized to work for Pfizer in the U.S. and, if so, whether that authorization permits them to work in the job they seek. In no case should Pfizer's support of a colleague's temporary visa application or sponsorship of a colleague for permanent residence be construed to guarantee success of that application or amend or otherwise invalidate the "at-will" employment relationship between the colleague and Pfizer. *This job post was placed on PharmaDiversity Job Board with permission of this employer. If viewing this post anywhere else, the "apply" click should lead you to PharmaDiversity Job Board for authentic job post view with direct employer application. For application attention if web source is requested please use "PharmaDiversity" or "PharmaDiversity Job Board". Pfizer prefers that you apply to this job directly on their site