1+ months

Senior Scientist, Regulated Bioanalytical Support, Assay Development

Andover, MA 01810

+ Responsible for leading operational support for the oversight of Contract Research Organization (CRO) based regulated non-clinical bioanalytical activities for the Large Molecule Pfizer portfolio. Activities include assay development, validation, and regulated sample analysis via LBA and PCR in support of BA, ADA, biomarker, and TK analysis.

+ Work with department project leads to coordinate non-GLP in life studies (rodent, monkey) conducted by CRO. Assist with management of sample analysis and data review, as needed.

+ Expected to work highly independently under a supervision of a Principal Scientist or higher

+ Work within the immediate BA group with the Bioanalytical Principle Investigators (BA PIs) and with the Global compliance team to identify appropriate CRO vendors

+ Oversee and lead CRO vendors to ensure on time delivery of required milestones including related logistical support, documentation and data delivery

+ Independently and proactively communicate with CRO vendors to ensure transparency and adherence to the timelines, appropriate level of compliance (e.g. GLP), 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

+ Oversee and lead vendor compliance including performance metrics, arrange technical visits to vendor and generate trip reports, SOP review, participating in teams to review vendor requests for proposal led by Procurement, CP-102

+ Facilitate BA PI in technical reviews were possible

+ Lead review of the GLP compliance status at CROs


+ Lead oversight of Bioanalytical support conducted at external Contract Research Organizations (CROs)

+ Lead oversight of the appropriate compliance (e.g. GLP) status of CRO conducted activities

+ Facilitate in oversight of the 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, POs, and invoices

+ Gathers input from colleagues and additional resources to assist in driving the project forward

+ Additional responsibilities may include maintaining the regulated (GLP/GCP) status of Pfizer internally supported projects (e.g. QC review and clinical data management)

+ The colleague will share responsibility in collaborations with external departments and utilization of related software applications


+ A MS with at least 3+ years of relevant experience or BSc with 5+ years relevant experience is required.

+ Successful candidate will preferably have a good understanding of or experience in the oversight of externally conducted work (operational/technical).

+ Ability to multi-task multiple projects with overlapping timelines.

+ Excellent communication and presentation skills.

+ GLP/GCP laboratory experience is required with a preferred focus on ligand binding assay development in support of biotherapeutics.

+ Industry experience with a focus in biotherapeutics.

**Technical Skill Requirements**

+ Basic understanding of the relevant technical capabilities is desired. CRO support is focused on design, development and implementation of ligand binding assays (e.g. ELISA, ECL detection, fluorescence detection, PCR) in biological matrix (plasma, serum, tissue) to measure compound concentration, detection presence of anti-drug antibody and neutralizing anti-product antibody activity in a regulated (GLP) environment.

+ Strong familiarity and hands on experience with the GLP compliance.

+ Excellent documentation skills.

+ Ability to clearly and concisely state the goals and deliver information.

+ Ability to work with tight timelines on multiple projects.

**Behavioral Competencies**

+ Ability to lead others in a matrixed environment.

+ 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.


+ Knowledge and hands-on experience in electronic notebook, LIMS, and document management systems is a plus.

**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.

**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.


**Other Job Details:**

+ Eligible for Employee Referral Bonus

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

Research and Development


Posted: 2019-10-21 Expires: 2020-02-14

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Senior Scientist, Regulated Bioanalytical Support, Assay Development

Andover, MA 01810

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