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Manager/Team Leader, Reference Qualification Project

Lead a group of advanced-degree, highly skilled professionals on project teams for the replacement, clinical qualification, and first time approval of references used in veterinary vaccine potency tests. Assure compliance with the Reference Qualification program standards & procedures; initiate reference qualification preparation including mid-date stability report & review of product changes, perform assay suitability review & re-development needs including development of internal/external assays and replacement of reagents, perform reference formulation review & re-development needs including the execution of reference lyophilization protocols & production of qualifying serial(s), perform clinical model review & coordinate optimization including overseeing clinical studies and challenge preparation & qualification, and oversee the preparation of pivotal reports including assay validation, reference mid-date stability & clinical reports.

May serve as Principle Investigator for clinical studies. Job duties also include administrative duties such as preparing and tracking the expense budget (FTEs, animals, materials), maintaining progress dashboards, and providing periodic updates to Senior leadership in PGM & PAH. In addition, individuals in these positions may lead occasional meetings with USDA Policy, Evaluation, & Licensing (PEL) officials to influence USDA on technological advances and statistical evaluations.

DVM candidates will serve as back-up to the site Attending Veterinarian.

Qualifications:
B.A./B.S. in science or related degree with equivalent experience and a minimum of 9 years equivalent experience or DVM. Previous successful experience as a project leader for clinical and/or analytical studies. Experience with developing and qualifying immunoassays is required. Understanding of disease pathogenesis & laboratory clinical assays. Experience in a biological manufacturing environment with understanding of biotherapeutic/vaccine lyophilization and stabilization.

Technical knowledge and/or expertise in bacteriology & virology techniques, and validation principles. Understanding of basic statistical analyses used to evaluate analytical & clinical studies. Ability to resolve technical issues and troubleshoot analytical tests and clinical studies.

Ability to describe and defend complicated analytical and clinical data to company and regulatory agency personnel. Strong computer skills. Thorough knowledge of 9CFR and EU regulations, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs), and Good Clinical Practices (GCPs).

Demonstrated ability to lead professionals with advanced degrees in biological or veterinary science. Demonstrated ability to effectively lead/develop others and optimize team performance. Strong communication (oral and written), interpersonal, and team/group interactive skills. High integrity and self motivation. Demonstrated high level of attention to detail.

Preferred Qualifications:
M.A./M.S/PhD in biological or molecular biological sciences with a minimum of 7 years relevant experience. Applied skills in immuno-, biochemical, or molecular biological assays preferred. Prior supervision or experience in leading 5+ colleagues in a technical field.

Training in leadership and management techniques consistent with Pfizer values and leadership competencies. Strong experience in USDA and VMD regulations with thorough knowledge of 9CFR 113.8. Prior Lean methods training. Certified in RFT Six-sigma applications.

Throughout our 153 years, a legacy of caring for others has been at the heart of everything we do at Pfizer. This commitment is no less important when it comes to our employees. Pfizer wants to ensure that employees have resources to help them develop and succeed both in their careers and personal lives. One way we can achieve this is through our comprehensive benefits program, which offers employees and their eligible dependents the variety and flexibility to help address their needs at different stages in life.

Pfizer Inc. discovers, develops, manufactures, and markets leading prescription medicines for humans and animals. Our innovative, value-added products improve the quality of life of people around the world and help them enjoy longer, healthier, and more productive lives. The company has two business segments: health care and animal health. Our products are available in more than 150 countries.

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 possess or obtain authorization to work in the U.S. for Pfizer. Pfizer retains sole and exclusive discretion to pursue sponsorship for the acquisition or maintenance of nonimmigrant status and employment eligibility, considering factors such as availability of qualified U.S. workers. Individuals requiring sponsorship must disclose this fact.

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