Associate Scientist- Stability

BMS

(Syracuse, New York)
Full Time
Job Posting Details
About BMS
Bristol-Myers Squibb is a global BioPharma company firmly focused on its mission to discover, develop and deliver innovative medicines to patients with serious diseases.
Summary
The role of the Stability Associate Scientist is to support the activities of the Syracuse Quality Control Stability program which includes stability study administration to support site manufacturing; as well as, stability programs for other sites and Third Party Manufacturers (TPM).
Responsibilities
* Administer Stability Programs by maintaining a schedule of pull dates required for testing, preparing for or providing oversight for the sample pulls as required by schedule. * Communicate directly with management information regarding stability samples or testing that may impact lab capacity or product studies. * Monitor specification changes and ensure appropriate specification and method changes are updated for studies. * Draft study protocols and manage study programs as required. * Monitor and assess stability data and prepare trend graphs; reporting unusual trends to management for review. * Provide Stability LIMS Administration Support for the department, including but not limited to study administration, maintenance, training, etc. * Support activities of Stability and Reserve Sample Facility as needed. * Ensure training requirements are met. * Author and/or revise GMP documents. * Serve as a qualified trainer. * Maintain the office and stability facility in accordance with cGMP. * Initiate and promote change as part of operational excellence.
Ideal Candidate
* Specific Knowledge, Skills, Abilities, etc: * Knowledge and understanding of ICH Guidelines (Q1A, Q5C) and associated BMS policies, directives and guidance documents. * Problem solving ability, interpersonal, oral and written communication skills; as well as technical writing skills. * Able to prioritize objectives from multiple projects, adhering to scheduled timelines. * Work independently and contribute to a team based environment; promoting a high commitment to business goals and objectives. * Computer skills required: Microsoft Office applications, SAP, LIMS, Trackwise, etc. * Education/Experience/ Licenses/Certifications: * Bachelor’s degree in a scientific discipline with a minimum of 5 years experience or a MS degree with one to two years experience. * Physical Demands: * The physical demands of the job may include but are not limited to: Unassisted lifting of items, not to exceed 50 lbs, Bending/Stooping, Twisting, Crouching/Squatting, Kneeling, Sitting, Crawling, Walking-Level Surfaces, Climbing (Ladder), Reaching (Shoulder), Repetitive (Use of Arm, Hands, Wrists).

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