Director, Biologics Commercial Technical Services

Celgene Corporation is a global integrated biopharmaceutical company primarily engaged in the discovery, development and commercialization of innovative therapies designed to treat cancer and immune-inflammatory related diseases in patients with limited treatment options.

• The Director, Biologics CTS is responsible for leading all aspects of late stage development and commercialization of Process Development as it relates to Celgene’s biologics product portfolio.
• The major responsibilities include the development and oversight of technology development, product comparability and technology transfer at different manufacturing scale facilities (mammalian cell process).
• Oversight of API development of 5+ biologics candidates in Research Pipeline.
• Require supervision of 2-3 chemical engineers/biochemical engineers
• He/She will have a functional leadership role for API development and scale-up in the Biologics Commercial Technical Services (CTS) group.
• Functional leadership involvement and responsibility for
  • Health Authority interactions (i.e. audits, questions and submissions)
  • CMO selection, auditing, project planning, contracting and management
  • New Biologics opportunity and technology assessments
• Manages development and scale-up activities for manufacturing of biologic products drug substance.
• Provide leadership and technical direction to cross-functional teams to assess and maintain process and product comparability across sites and scales and in data intensive process investigations
• Contribution and oversight of the CMO process and validation documentation.
• Evaluating/Developing new technologies associated with bioreactor operations. Function as independent or large multi-disciplinary teamwork
• Lead initiatives to assess and maintain process and product comparability across sites and scales
• Identify opportunities for improving process yield and consistency
• Support business process improvement initiatives to improve the operation of the biologics manufacturing.

• Other key responsibilities include, but are not limited to, the following:

  • Collaborating with key stake-holders (e.g., different functional groups to drive development of biologics pipeline)
  • Serves as important liaison to external contacts and licensing partners on CMC activities.
  • Applies influence and negotiation skills to drive business results

Prerequisites:

• Ph.D. degree & 9 years of directly related experience
• Master’s degree & 13 years of directly related years, and 5 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources.
• Major in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline.

Skills/Knowledge Required:

• In depth understanding and application of principles, concepts, practices, unit operations and standards along with an in depth knowledge of biologics proteins manufacturing and corresponding cGMP industry practices.
• Technical understanding of the regulatory and compliance requirements of protein therapeutics
• Demonstrated ability to function in a collaborative/team oriented environment.
• Strong communication, collaboration and team building skills; ability to connect with all levels of the organization
• Able to develop solutions to moderately complex problems, which require the regular use of ingenuity and innovation
• Good verbal and written communication skills. Sound organizational and time management skills
• Experience in cell culture process development and technology transfer and/or knowledge of mammalian cell physiology and metabolism.
• Strong background in cGMP biologics manufacturing, Display a strong focus on quality, detail and results.
• Project management skills and the ability to influence others without direct authority is a highly desirable characteristic for this position.