Associate QC Scientist (Equipment Qualification, Lifecycle Management)
Posted on Feb 1, 2019 by Bristol-Myers Squibb Company
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. Driven to make a difference, from innovative research to hands-on community support. 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 the resources to pursue their goals, both at work and in their personal lives.
The Bristol-Myers Squibb Devens site is a state-of-the-art biologics manufacturing facility located on 89 acres, just 45 minutes west of Boston. It is here that we will be fulfilling our critical mission to help patients prevail over serious diseases.
This 400,000 square foot complex represents the single largest capital investment in the nearly 125 year history of BMS, $750 million, and is a key part of our strategic BioPharma transformation.
Associate QC Scientist needed for the Quality Control Technical Support team in Devens, MA to lead and participate in analytical instrument qualification such as Chromatography systems, Immunoassay equipment, TOC, FTIR, SpectraMax L, AKTA, and Karl Fisher. Lead validation activities including development and execution of IQ/OQ/PQ Protocols/Reports and Lifecycle Management of instrumentation.
Major Duties and Responsibilities:
- Lead and participate in analytical instrument qualification and validation activities including development and execution of IQ/OQ/PQ Protocols/Reports and Lifecycle Management of instrumentation.
- Execute equipment troubleshooting activities to support method performance and enhancements.
- Peer review and communication of instrument qualification in a concise, organized, and compliant manner.
- Identify and drive business improvement projects on site/across network.
- Author SOPs and training documents.
- Train and assist less experienced scientists within area of expertise.
- Support health authority inspections.
- Knowledge of science generally attained through studies resulting in a BS/MS Degree or equivalent preferably in Biological Sciences.
- A minimum of 4 years (MS) or 6 years (BS) relative experience in scientific QC methodologies, Biologics QC laboratory, or related biopharmaceutical cGLP or cGMP lab.
- Strong expertise in operational knowledge of analytical instruments and instrument qualifications.
- Knowledge of applicable business systems including: Trackwise, Maximo, MS Project.
- OpEx, Lean/Six Sigma, Yellow Belt recommended.
- Strong working background in QC laboratory systems and applications including LIMS sample manager, LES and their integration to other systems.
- A thorough knowledge of cGMP regulations as referenced in The Code of Federal Regulations (21CFR) and their specific application to quality control laboratories in a biologics manufacturing facility.
- Strong problem solving ability, interpersonal, oral and written communication skills.
- Ability to prioritize objectives from multiple projects, adhere to scheduled timelines while maintaining flexibility and attention to detail.
- Contribute to a team based, collaborative, and positive environment, with clarity of purpose and a high commitment to business goals.
This role has business need to interact daily with any employee at any level of the Devens facility including members of the site Quality organization, other Quality staff, Automation, IT and Technical Services. Occasional contact from outside vendors.
Work is largely performed in a modern office and a cGMP laboratory/manufacturing facility where one must maintain a high attention to detail and be aware of the presence of workplace hazards including biohazards and hazardous chemicals. The use of Personal Protective Equipment (PPE) will be required in the laboratories.
Works with peers to ensure alignment of priorities and agreement of project ownership.
Receives assignments in the form of objectives and established goals to meet objectives. Work is reviewed and measured based on meeting established objectives and schedules. Identifies and reports any discrepancies from normal practices or procedures to management, recommending and implementing corrective actions.
Bristol-Myers Squibb Company