Associate Scientist GxP Sample amp Data Management

Profile

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Summary:

This position is part of the Sample and Data Management group, and as such requires the handling of clinical biologics materials/samples, including monoclonal antibodies, fusion proteins, antibody-drug conjugates and fixed drug ration combination products to support clinical therapies, particularly immuno-oncology and oncology agents. In this role, personnel are responsible for domestic and international shipping of Clinical Biologics samples, sample submission/distribution activities, sample inventory, and other GxP compliance activities as assigned. This individual will also support other tasks in the Clinical Biologics Network including method facilitation, COA issuance, PD LIMS Builds and corrections, and other tasks as assigned.

Responsibilities:


Manages the day to day shipping requirements for the Clinical Biologics samples and the requirements and paperwork for those shipments. This task requires a high level attention to detail, knowledge of the shipping regulations for domestic and international shipments, as well as the safety precautions required for Band 4 and 5 Biologics molecules.
Responds to audit comments forGMP samples comments which are received and proposes potential corrections for future samples, training his direct reports on the required corrections.
Creates PD LIMS Input forms as cross-training initiative for the group as well as to learn new skills.
Actively training with other areas in the group in order to be able to issue Clinical Biologics Certificates of Analysis (COAs and Detailed Sample Reports (DSRs) as needed.
Point person for certain functional areas during GMP audits, which includes answering questions as a Subject Matter Expert (SME) for both Freezerworks and PD LIMS tasks related to sample processing, as well as investigations/discrepancies involving samples related to GMP.
Coordinates interactive communication with project ATLs to ensure smooth shipment of samples for testing so as not to delay projects for FIH and other time sensitive company commitments.
Trains all new SDM sample employees for all of the required tasks for the role.
Process incoming and outgoing samples, for release, re-assay, stability, validation and development testing including reagents and reference materials to support clinical development activities.
Administration of sample tracking activities and sample documentation for receipts, shipping and inventory of samples and reference standards.
Maintains routine shipping documentation for all samples for both incoming and outgoing shipments.
Support department analysts by providing sample and reference standard retrievals and inventory reports utilizing Inventory.
Release samples for testing using departmental notification procedures.
Submit and log in samples in PDLIMS andInventory for such materials as:
Clinical release and re-assay
Long Term Stability Studies (LTSS)
IND, IMP, and BLA submissions
Analytical Method Development and validation of Analytical Methods
Adhere to cGMP, good documentation practices, departmental procedures and safety requirements, maintaining control of incoming and outgoing samples and other materials for validation work, development projects and outsourced testing.
Provide support to personnel in generating and extracting sample information and documentation.
Document relevant activities in equipment log books that includes equipment performance, review of calibration, maintenance and inventory of all freezers and refrigerators used to store materials.
Data Verification for Certificates of Analysis, and other Technical Documents prior to review and approval.
Clearly and accurately document work reflecting movement, handling and aliquotting of samples on worksheets and logbooks. Maintain records to ensure accurate inventory and traceability.


Education/Experience/Knowledge:


Bachelor's Degree in a Scientific Field of Study.
Must have a minimum of 1-2 years of relevant experience in a pharmaceutical/medical setting or relevant academic study in biological science discipline.
Proficient in Use of Electronic Systems: PC based software, such as Freezerworks, PDLIMS, DEVLIMS, TrackWise, and Microsoft Office suite of applications.


Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1526848_EN

Updated: 2020-06-25 00:00:00.000 UTC

Location: New Brunswick,New Jersey

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

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