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Bioanalytical Outsourcing, Clinical Assay Specialist

Pfizer


Location:
San Diego, CA
Date:
08/22/2017
2017-08-222017-09-20
Job Code:
1604133
Pfizer
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Job Details

Job Title Bioanalytical Outsourcing, Clinical Assay Specialist

JobID 1604133

Location: San Diego, CA

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.



+ Responsible for bioanalytical support for clinical PK (and occasionally, biomarkers) at the CROs or in collaboration with the internal laboratories. Leads and oversees LC/MS based bioanalytical assay development or transfer, validation, and sample analysis in support of clinical programs. Assists with effective troubleshooting of the bioanalytical assay and issues resolution. Provides scientific rational for selecting a methodology and technique for high complexity assays, e.g., hybrid LC/MS/MS or HRMS assays for large molecules PK, ADCs and new modalities.

+ Serves as the PK (and, occasionally, biomarkers) assay representative on clinical teams ensuring that the bioanalytical support is meeting program/study needs and scientifically sound, and provides effective bioanalytical study management, communications, set up and budgeting, vendor selection, and delivery of bioanalytical data and reports supporting clinical program within the expected timelines.

+ Evaluates and reviews data, bioanalytical 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 meeting regulatory submissions requirements.

+ Selects, qualifies, manages, and audits external CROs (located globally).

+ Assists in writing regulatory submissions and responding to relevant regulatory queries.

+ Demonstrates deep understanding and provides interpretation of SOPs and Policies governing conduct of clinical trial, including Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), and Good Clinical Practice (GCP) and guiding clinical and regulatory teams on studies specific bioanalytical requirements to support submissions.

+ Stays abreast of literature, modern and novel technologies in the bioanalytical space, regulatory guidances (including international regulations and guidances), industry best practices, White Papers, as appropriate, relevant to clinical bioanalysis to ensure practices are consistent with regulatory expectations and high scientific standards.



Basic Qualifications



+ Minimum BS degree in analytical chemistry/ chemistry or biology.

+ Previous experience performing and/or outsourcing LC/MS based regulated bioanalysis (5-7 years of the relevant experience)

+ Working knowledge of wide range of bioanalytical techniques based on chromatographic separation (e.g., HPLC/UPLC/GC, various sample preparation techniques, and mass spectrometry detection platforms, etc.).

+ Demonstrated understanding of global regulatory requirements including GLP, GCLP and the clinical trial process.



**EEO Statement**

**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 Offer Details:**



+ Grade: 08

+ **Additional Location Information: La Jolla, CA**

+ Eligible for Employee Referral Bonus

+ Relocation Assistance: Yes



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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