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Large Molecule Clinical Assay Specialist, Senior Manager

Pfizer


Location:
Groton, CT
Date:
08/22/2017
2017-08-222017-09-20
Job Code:
1045076
Pfizer
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Job Details

Job Title Large Molecule Clinical Assay Specialist, Senior Manager

JobID 1045076

Location: Groton, CT

Description 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.



The Clinical Assay Group (CAG) within the Clinical Pharmacology department is seeking an experienced large molecule bioanaltyical scientist to lead scientific and operational oversight of pharmacokinetic (PK), immunogenicity (ADA and Nab), and soluble target assays and bioanalyses conducted at external contract research organizations (CROs) or in collaboration with internal laboratories. This role requires strong communication, ability to work in a fast paced global matrixed environment, ability to handle complex processes and tasks, and hands on experience in design, review, and execution of ligand binding (ELISA, ECL) and cell based assays. In this role, the successful candidate will:

• Lead and oversee assay transfer/development, assay validation, bioanalysis, and troubleshooting of clinical PK, immunogenicity, and soluble target assays conducted at external CROs and internal laboratories.

• Serve as the PK and ADA assay representative on clinical teams ensuring effective management, communication, set up, budgeting, and delivery of bioanalytical data and reports within expected timelines.

• Evaluate and review raw data and study analytical reports and assay validation reports, as appropriate, to ensure laboratories are performing analysis in compliance with current regulatory, industry, and Pfizer standards and that data are of the required quality (regulatory and scientific).

• Select, qualify, manage, and audit external CROs located globally.

• Assist in writing regulatory submissions and in responding to relevant regulatory queries.

• Stay abreast of bioanalytical science, new technologies, regulations, and SOPs/internal guidances to ensure compliance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and regulatory expectations.

• Influence internal and external environment through scientific presentations/publications, Clinical Assay initiatives and sub-teams, and cross line initiatives and sub-teams.



QUALIFICATIONS

• Minimum BS degree in biological sciences/analytical chemistry.

• ≥7 years relevant experience performing and/or outsourcing regulated large molecule bioanalysis.

• Working knowledge of wide range of large molecule bioanalytical techniques (e.g., ELISA, ECL, Gyros, FACS, RIA etc).

• Demonstrated understanding of global regulatory requirements including GLP, GCP and the clinical trial process.



TRAVEL

• Limited travel for vendor audits, conferences, and training (5%).



- Eligible for Employee Referral Bonus



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.



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.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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