Senior Scientist, PDPI Manager Job in San Diego, California US
Senior Scientist, PDPI Manager
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 Senior Scientist position is responsible for the technical problem solving activities for a regulated veterinary diagnostic product line including ELISA, lateral flow, AGID, and rapid agglutination technologies. The position is at a manufacturing facility. Activities will include process improvements to existing products, validation of new processes, and transfer activities. Transfer activities include commercialization of products from RD as well as from existing manufacturing sources. Responsibilities will include design/development, implementation, and related documentation. The position will supervise at least one Scientist level employee. Responsibilities "Identify, implement, and report on improvements in manufacturing processes utilizing a cross-departmental approach interacting with management, manufacturing, quality, regulatory, RD, etc. "Design, implement, and draft reports of equipment and process validation studies. "In consultation with Marketing Product Managers and Technical Resource Leaders, identify products needing improvement (i.e. resolution to customer feedback, improvement in product performance). "Work with site leadership to assemble transfer team and assign leadership of team. "Transfer, and adapt where necessary, manufacturing documents and processes to Synbiotics manufacturing capabilities and methodologies. "Design and implement pilot scale batches utilizing a cross-departmental approach. "Supplier and material validations. "Supervise product commercialization of regulated veterinary diagnostics. Qualifications "MS in immunology, microbiology, biochemistry, chemistry, or related discipline plus 10+ years of relevant experience (ELISA, AGID, rapid agglutination, conventional diagnostics, and/or lateral flow manufacturing and development, protein purification/conjugation). "Ability to work both independently (problem solving, design of experiments) and with others (good interpersonal skills) in a laboratory setting. "Strong project management skills. "Previous experience in a medical device or diagnostic company with FDA or USDA experience following GMP/GLP, ISO, or other quality guidelines highly desirable "Previous personnel management experience desirable 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