Associate Director, Parenteral Characterization Laboratory
Posted on Apr 6, 2021 by Bristol-Myers Squibb
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.
Associate Director, Parenteral Characterization Laboratory, MS&T
The Associate Director, Head of the Parenteral Characterization Laboratory, defines the technical agenda, and leads the design and execution of process characterization studies and other experimental or in-depth technical capabilities to troubleshoot, optimize and enhance parenteral commercial manufacturing. In partnership with the Parenteral MS&T Leadership Team, contributes to the strategic technology roadmap for parenteral manufacturing.
This position leads the experimental technical team responsible for design and execution of process characterization, process mapping and new technology evaluation to ensure robust and cost effective manufacturing processes across the global parenteral internal and external commercial manufacturing network. Additional responsibilities include the implementation and roll-out strategy for new technologies, in collaboration with Quality, Regulatory, Procurement, MS&T, Development and Operations partners. Additionally, the team should provide as needed specialized expertise, such as filter validation, lyophilization, and others to complement site capabilities for technically complex product investigations, process improvements or resolution of direct materials issues. This position reports to the Director of New Products and Lifecycle Technology of Parenteral Manufacturing Sciences and Technology, within Bristol-Myers Squibbs Global Product Development and Supply.
Key responsibilities include
Execution of post-market process change activities/experiments through partnership with R&D.
Characterization, optimization and troubleshooting product and manufacturing processes of parenteral dosage forms.
Collaboration with R&D and manufacturing sites to design and execute experiments to support product robustness, new technology implementation, and/or manufacturing investigations
Serve as technical resource to other functions, providing expertise on the product and its process.
Effectively represent parenteral manufacturing science and technology in various internal and external teams committees and industry groups on development, technology transfer, manufacturing, specifications, process validations and launch.
Provide assistance to sites globally to resolve significant quality events that require in-depth parenteral technical expertise
Lead and manage a team of scientists;
Author, review and approve protocols, reports and co-author sections of CMS filing
Bachleors degree with 14 years of relevant experience. Master and Ph.D. is preferred (but not required). Time spent in advanced degree program may consider as equivalent experience.
Key Skills and Experience
Hands-on experience in the laboratory and demonstrated history of successfully leading experimental teams that have resolved complex technical challenges.
Excellent skills/experience working in cross-functional teams and championing complex technical projects with various stakeholders.
In-depth understanding of sterile and liquid products, particularly biologics commercial manufacturing and associated unit operations.
In-depth understanding of Quality by Design (QbD), Statistical Design of Experiments (DOE), multivariate analysis, PAT, critical process and material attributes and CQAs.
Working competency of Statistical Process Control and related tools (JMP/MiniTab/SAS)/
Skilled in writing and reviewing complex study plans and scientific reports.
Demonstrated in-depth mastery of sterile product processing equipment, analytical tools and manufacturing facilities.
In-depth knowledge of parenteral technology & unit operations, aseptic processing, sterilization, isolator processing, lyophilization, pre-filled syringe operations, etc.
Strong understanding of project management systems and tools.
Six Sigma Green/Black Belt certification desirable