Executive Director Cell Therapy Technical - Devens, United States - Bristol-Myers Squibb

Mark Lane

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Mark Lane

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Description

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.


The Executive Director, CT Technical Operations Drug Product will have global responsibility in providing strategic leadership and direction for product support for commercial cell therapy products manufactured globally.

This role is a member of the CTTO leadership team. This role will have accountability for the life cycle management project execution for drug products
- both commercial and pipeline assets, commercialization of late-stage technology projects, automation technology process improvements, vector & drug product comparability, facility design & process input for buildout of new internal DP facilities and external CMOs, and drug product technology transfers. This role is also accountable for Technical Operations Services that include Raw Materials, Packaging and Single Use systems to support validation, LCM, and comparability studies. This role will manage a technical team of over 50 people. This role will work in close contact with the site MS&T groups to ensure best practices and consistent approach across the cell therapy global manufacturing network. This role collaborates with Manufacturing, CMC, Regulatory, SC, Quality, QC, F&E, Process Development, Analytical Development, IT, and Finance.


Key responsibilities:


  • Maintain a robust support network for all commercial CTTO activities related to LCM, new technologies, automation, comparability, and tech transfers
  • Oversee implementation of LCM, new technology and automation projects at all manufacturing sites to improve robustness, scalability and COGM/TAT/RFT for approved cell therapy products
  • Lead and develop strategies for cell therapy comparability exercises to enable change implementation
  • Manage activities in global labs to support LCM change implementation, validation, and comparability efforts
  • Partner with product technical stewards and Regulatory teams to align on strategy and manage implementation
  • Ensure technical and manufacturing requirements are addressed throughout lifecycle of new solutions
  • Review technical reports, source documentation and filing sections to support product lifecycle and regulatory submissions
  • Serve as a senior technical leader, in management and governance forums, providing input to advance CT & GPS strategic priorities
  • Recruit, retain, and develop a diverse staff of highly capable technical leaders, scientists, and engineers to create a worldclass CTTO organization
  • Manage group budget and expenses.

Education and Experience:


  • Bachelor's Degree in in Biomedical/Chemical Engineering or equivalent Engineering discipline required; Master's or PhD degree preferred
  • At least 15 years of experience in cell therapy, pharmaceutical and/or biotechnology fields, product development, manufacturing operations and/or Quality experience in the transfer, filing and launch of new products
  • Experience managing projects of significant complexity and duration
  • Experience in developing talent, managing change, engaging and motivating people and developing organization and work structures

Knowledge and Skills:


  • Ability to lead and influence multidisciplinary, crossfunctional teams
  • Ability to critically assess overall risk to project timelines/plans and resolve or escalate appropriately
  • Demonstrated (complex) project management leadership and innovative thinking
  • Excellent verbal and written communication skills
  • Excellent technical skills and problem solving skills
  • Knowledgeable in manufacturing sciences, cGMP compliance, change management methodology, and product regulatory requirements
  • Expert in technical information management and data analysis in all stages of development and commercialization
  • Demonstrated success in driving optimal business objectives in a complex matrix organization

Travel:
This role requires about 25% travel domestically with occasional international travel.


Additional professional and personal requirements include:

  • Strong organizational skills, ability to multitask and work in a dynamic, fast paced environment
  • Experienced in leading change and a demonstrated ability to accomplish results and meet deadlines and commitments


The starting compensation for this job is a range from $245,000 USD - $325,000 USD, plus incentive cash and stock opportunities (based on eligibility).

The starting pay rate takes into account characteristics of the job,

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