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Sr. Group Leader, Analytical Development Biosimilars AR&D


Lake Forest, IL
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Job Details

Job Title Sr. Group Leader, Analytical Development Biosimilars AR&D

JobID 1034916-1852

Location: Lake Forest, IL

Description *About Pfizer*

A career at Pfizer offers opportunity, ownership and impact.All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

*Role Description*

Hospira, a Pfizer company, is a leading provider of infusion technologies. The company's focused infusion systems portfolio features I.V. solutions, proven, innovative smart pumps, and pain management and safety software technology designed to help meet clinical, safety and workflow goals. The Sr. Group Leader will lead a group of scientists within Biosimilars Analytical R&D supporting biologics programs and functional initiatives. He/she will define the technical agenda for his/her group or focus area and ensure alignment of the agenda with the relevant organizational goals. The Senior Group Leader will also lead the development of analytical control strategies for assigned biologics programs and define approaches for demonstrating analytical similarity in support of regulatory submissions. He/she will ensure alignment of these strategies across biologics programs/platforms and with the relevant industry benchmarking and regulatory expectations.


* Lead technical execution of defined analytical strategies for biosimilar products, including biosimilarity assessment, CQA assessment, specification development, reference standard establishment and characterization. Lead or participate cross-functional collaborations with process/formulation development or operations to define integrated product control strategies and support drug substance/drug product development/manufacturing.* Provide coaching, training, and administrations of performance management to his/her direct reports and other scientists within the Biosimilars Analytical R&D group.* Develop project and resource plans to support the biologics programs assigned to his/her team. Drive and coordinate analytical method development, optimization, qualification, and validation activities across global analytical sites.* Ensure timely completion of high-quality technical reports/protocols and integrated cross-functional reports and/or strategy documents. Primary author and/or reviewer for analytical sections of regulatory submissions and/or briefing documents to support clinical development and marketing authorization.* Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Lead the evaluation and/or implementation of new analytical technologies/methods to advance Pfizer's current analytical capabilities. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.


Master's Degree required in Analytical Sciences, Biochemistry or related field. Ph. D. preferred.More than 6 years of experience in biotechnology or pharmaceutical industry supporting the development and/or commercialization of therapeutic recombinant proteins is required.

*EEO & Employment Eligibility*

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 work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

*Sr. Group Leader, Analytical Development Biosimilars AR&D*
*Lake Forest, Illinois*

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