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Project Manager, CRO


Andover, MA
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Job Details

Job Title Project Manager, CRO

JobID 1048696-1852

Location: Andover, MA

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*

*Provide operational support for Contract Research Organization (CRO) based bioanalytical support *Work under a supervision of a Senior Scientist or higher with high degree of independence *Work with Bioanalytical Principle Investigator (BA PI) to identify appropriate CRO company*Interface with the CRO to ensure on time delivery of required milestones *Proactively communicate with the CRO to ensure transparency and adherence to the timelines, availability of required contracts, quotes, purchase orders, provide CRO with critical material, obtain and archive needed documentation, work with CRO to reconcile any charges to Pfizer, manage standing project review meetings, arrange vendor visits*Facilitate BA PI in technical reviews were possible *Facilitate with review of GLP compliance status at CROs *CRO support is focused on design, development and implementation of ligand binding assays (e.g. ELISA, ECL detection) in biological matrix (plasma, serum) to measure compound concentration, detection presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP) environment*Basic understanding of the above technical capabilities is desired


*Project management position *Primary responsibilities include oversight of Bioanalytical support conducted at external Contract Research Organizations (CROs)*Secondary responsibility is to facilitate with compliance (GLP) and technical project reviews, work with bioanalytical principle investigators (BA PI)*Management of project related activities is required, including request, distribution and archiving of relevant documentation, meeting scheduling, communication with CROs and Pfizer groups, obtain and reconcile quotes and POs *Gathers input from colleagues and additional resources to assist in driving the project forward *Additional responsibilities will include providing operational support for maintaining the regulated (GLP/GCP) status of laboratory equipment *The colleague will share responsibility in collaborations with external departments and utilization of related software applications to schedule routine & non-routine maintenance, calibrations, installation/decommissioning of equipment


*BSc with at least 7 or MSc with at least 5 years relevant experience *Successful candidate will preferably have a good understanding of or experience in the oversight of externally conducted work *Excellent communication and presentation skills are required *Successful candidate will have some GLP/GCP laboratory experience with a focus on ligand binding assay development in biological matrix*Industry experience with a focus in biotherapeuticsTechnical Skill Requirements*Excellent documentation skills*Excellent communication skills *Ability to clearly and concisely state the goals and deliver information *Ability to work with tight timelines on multiple projects*A big plus is knowledge and hands on experience working under GLP regulations*A plus is knowledge and hands-on experience in ligand binding assays Behavioral Competencies*Adaptability to changing work assignments and priorities*Collaborative skills and effective partnering skills in a complex, multi-discipline organizational model *Excellent teamwork*Interpersonal and communication skills*Able to identify opportunities for continuous improvements and enable implementation*Ability to work across a matrix team

*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.

*Project Manager, CRO*
*Andover, Massachusetts*

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