Manager, New Product Introduction (NPI)

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 3 years’ experience, in a GMP laboratory setting with QC release testing.
• Understanding of the needs and best practices of routine biopharmaceutical drug product and drug substance laboratories is desirable, strong background in chromatography and aseptic manufacturing is an advantage.
• Demonstrate leadership ability and flexibility along with good communication and team-work skills. Excellent communication skills are critical. Ability to communicate on a global level is required, in addition to meeting management skills.
• Excellent organisational and planning skills.
• Experience in some of the following analytical techniques are required: HPLC, CE, KF, SDS-Page, UV, iCIEF, Bioassay.
• The candidate must have experience in electronic systems such as LIMs/CIMs and Trackwise/Infinity. Experience in the use of digital scheduling tools is preferred.
• Demonstrated experience in corporate and regulatory audits.

THE ROLE

BMS Cruiserath Biologics is seeking to recruit on a fixed-term contract Manager, New Product Introduction (NPI), for the QC Release team, reporting to the QC Release Senior Manager. The successful candidate will manage a team of analysts within the QC Separations team for the Global Biologics Laboratory. In addition, will be responsible for leading and the coordination of analytical testing for new product introduction (NPI) Engineering and PPQ campaigns with responsibilities for oversight of scheduling of testing, approval of results and COA and report issuance.

KEY DUTIES AND RESPONSIBILITIES:

• Leading and engaging a team of QC analysts and senior analysts and recruiting where necessary.
• Oversight of PPQ projects including protocol review, sample receipt support, scheduling of analysis/review and communication of results.
• Collaboration with project stakeholders, ensuring timely communication of progress and completion dates
• Management of training programmes for QC personnel
• Use of OPEX tools to maximise efficiencies and adequately support production and other departments.
• Co-ordination of consumable inventory with external stakeholders and Vendor Managed Inventory stakeholders. Compliance with Standard Operating Procedures and Registered Specifications.
• Maintain within the QC Separations laboratory, current corporate and industry requirements and compliance trends as they pertain to laboratory operations.
• Participate in regulatory agency inspections as required.
• Ensure all laboratory activities are conducted in a safe manner.
• Conduct and support laboratory investigations.