The Executive Director, Biologics MS&T is responsible for scientific and technical oversight of Biologics manufacturing processes from full scale process validation through commercialization and life cycle management within BMS' internal and external network for biologics drug substance.
This leader with work in close collaboration with Biologics Process Development teams and Manufacturing sites in both Syracuse, NY and Devens, MA; as well as with a network of external manufacturers.
He/she will have direct strategic responsibility for leading a team of 100+ scientists to support a growing biologics portfolio.
In addition, all manufacturing support groups in plant will have a dotted line reporting relationship to this position.
This position reports to the Vice President of Global Biologics MS&T within the Global Manufacturing and Supply Division.
In collaboration with Biologics Process Development responsible for large scale technical transfer activities for phase 2b/3 clinical studies; establishes process control strategies and specification windows for manufacturing during commercialization at scale; assures that clinical batches are representative of process capabilities.
Responsible for process validation at scale from writing protocols through execution across the biologics drug substance manufacturing network.
Responsible for CMC authoring activities for BDS manufacturing.
Responsible for data management and process monitoring activities (Statistical Process Control).
Identify and implement commercial process and life cycle improvements.
Assure manufacturing operations are aligned with the registered process.
Provide oversight and support for technical investigations and change controls.
Define relevant operational/technical standards and practices for the manufacturing sites.
Define raw material and consumable specifications and standards for the manufacturing sites.
Establish platform for freeze/ thaw and storage conditions for biologics drug substance; responsible for all validation activities for drug substance storage containers, freezing, thawing and shipping, in coordination with the drug product manufacturing sites.
Qualifications A PhD with 15 years technical experience or a MS with 20 years of technical experience in the field of biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline and 10 years of managerial experience in a cGMP environment.
A proven track record and a solid history of technical accomplishments.
A strong practical knowledge of the technologies related to mammalian cell culture, protein purification, automation, validation and process engineering.
o Experience or strong familiarity of validation in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
o Experience in development of processes and technology transfer of processes for commercial biologic manufacturing.
An in-depth knowledge of regulatory requirements for filing biologics in the US and Europe, including hands on regulatory experience with the US and European agencies.
o Demonstrated success developing staff, including effective feedback and coaching.
Strong organizational skills and the ability to successfully manage multiple technical projects and priorities.
Analytical and strategic thinking skills and experiences.
o Knowledge of Lean Six Sigma tools.
Bristol-Myers Squibb is an equal opportunity employer - Vet/Disability - 1500314

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