Manager, QC Materials Technical Lead (Sample Management)

at  BristolMyers Squibb

WORKING WITH US

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.
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. Read more: careers.bms.com/working-with-us.

QUALIFICATIONS, KNOWLEDGE AND SKILLS REQUIRED:

• A minimum of a B.Sc. in Biochemistry or related discipline and must have at least 5 years’ experience, in a GMP laboratory setting with sample management experience.
• Knowledge of cGMPs pertaining to sample management.
• Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable.
• Demonstrated ability to influence work cross functionally in a dynamic and challenging environment.
• The candidate must have experience in electronic systems such as LIMS/CIMS, Trackwise/Infinity and SAP.
• Demonstrated experience in corporate and regulatory audits.
• Planning and organisation skills are required to plan, execute and manage resources against timelines and project commitments; must be able to adjust to changing priorities in a dynamic work environment.
• Excellent interpersonal skills are required, as is the ability to communicate well, both verbally and written.

THE ROLE

BMS Cruiserath Biologics is seeking to recruit on a permanent Manager, QC Materials Technical Lead (Sample Management), reporting to the QC Materials Senior Manager. The person covering this position will have responsibility for the development and oversight of the sampling and analysis plans for the Biological Drug Substance samples produced via the Multi-Product Cell Culture (MPCC) and Drug Product samples produced via the Sterile Drug Product (SDP) facility.
Based on your function, department or individual position, you will have the opportunity to discuss with your Manager the option to work remotely up to 50% of the time, over a two-week period, with the flexibility to choose the days that align with your collaboration needs.

KEY DUTIES AND RESPONSIBILITIES:

• Develop, maintain and oversee the sample management lab programs for the Drug Substance and Drug Product facilities.
• Oversee the QC VMI program, driving a lean capacity and keeping expiry losses at a minimum.
• Develop, implement and manage the inventory storage strategy of training samples and the Reference Standard Critical Reagent program for QC, supporting continued training, commercial testing and business continuity.
• Develop, implement and manage the operation of a buffer preparation program to support the daily testing requirements of QC.
• Provide technical expertise in areas such as sample processing activities, Drug Substance & Drug Product Sampling, retain program management & sample lifecycle controls.
• Provide technical leadership and guidance to the QC Sample Management team on the establishment of laboratory procedures and practices, quality system elements, equipment qualifications and cross-functional sample management support across Cruiserath Biologics.
• Support continuous improvement initiatives for the sample management lab by identifying areas needing improvement, recommending strategies for improvement, and implementing those strategies once approved.
• Support the review and approval of Material Science & Technology (MS&T) Drug Substance & Drug Product study protocols & reports as the Sample Management subject matter expert (SME).
• Support technical transfer activities for new product introduction.
• Provide SME support on QC, Manufacturing and Warehouse investigations involving QC sample components, including impact assessment, root cause analysis and Corrective/Preventative Action generation.
• Participate in and support audits, both internal and external (HPRA/FDA etc.) Act as the primary point of contact for audit discussions relating to sample management.
• Build and foster strong relationships within the biologics quality and global quality network to drive compliance, strengthen quality systems and support company objectives. Collaborate with network sites on technical issues to drive and maintain an aligned quality approach and foster an environment of continuous improvement.