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Senior Group Leader, Analytical Development

Pfizer


Location:
Lake Forest H3, IL
Date:
09/22/2017
2017-09-222017-10-21
Job Code:
1610029
Pfizer
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Job Details

Job Title Senior Group Leader, Analytical Development

JobID 1610029

Location: Lake Forest H3, IL

Description Join one of the leading Biosimilars Pharmaceutical Sciences organizations in the industry. As a leader in the biosimilars sector with approved products in the U.S. and Europe and an industry-leading biosimilars pipeline, Pfizer offers an exciting opportunity for a strong scientific leader to join our global biosimilars R&D team.



The Senior Group Leader will lead a group of scientists within Analytical Development supporting biologics programs and functional initiatives. He/she will define the technical agenda for his/her team or focus area and ensure alignment of the agenda with the relevant organizational goals. The Senior Group Leader will 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.



Responsibilities



+ 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 Analytical Development 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. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development.



Qualifications



+ 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.

+ Demonstrated scientific and people leadership skills. Experience leading teams of scientists with varying levels of experience and formal education (B.S./M.S. and/or Ph.D.) is required.

+ Extensive expertise in state-of-the-art analytical techniques for biologics product including HPLC/UPLC and Capillary Electrophoresis.

+ Extensive experience with the development and qualification/validation of analytical methods for biologics products.

+ Extensive experience with regulatory filings.

+ Experience defining and implementing analytical control strategies for biologics products.

+ Experience with cross-functional development of recombinant therapeutic proteins for pharmaceutical use, including knowledge of key regulatory and quality/compliance expectations.

+ Excellent verbal/written communication skills and the ability to lead cross functional and/or multi-geography teams.



**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.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**Additional Details:**



+ **This job is a Hospira Exempt US Grade: 20**

+ Eligible for Relocation Package

+ Eligible for Employee Referral Bonus



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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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