- 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 world-class 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, cross-functional 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 commitmentsThe 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, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience.
Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit our BMS Career Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.
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If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as Transforming patients' lives through science , every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
BMS has a diverse occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:
Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to . Visit eeo -accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. -
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Executive Director Cell Therapy Technical Operations - Summit, United States - Bristol Myers Squibb Company
Description
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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: .
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:
