Director, Technology Transfer, Analytical - Tulsa, United States - Bristol-Myers Squibb

Description

Director, Technology Transfer, Analytical & Process Implementations- Cell Therapy page is loaded

Director, Technology Transfer, Analytical & Process Implementations- Cell Therapy

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locations

Summit West - NJ - US

Devens - MA - US

Seattle - WA - US

time type

Full time

posted on

Posted 12 Days Ago

job requisition id

R

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.
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:
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At Bristol Myers Squibb we are reimagining the future of cell therapy.

With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure.

If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team.

Position Summary:
Come, join the BMS Cell Therapy Operations (CTDO) Division, and be a part of the team building leading cell therapy platforms to serve our patients with novel cellular

immunotherapies.

The Cell Therapy Technical Operations group plays a critical role in technology transfers, process validation, CMC life cycle management, technical oversight of external and internal manufacturing partners, process engineering and establishing manufacturing standards to enable a robust and scalable global cell therapy manufacturing network.

We are looking for a director to join our Process Robustness team within the Cell Therapy Technical Operations Function.
The successful candidate will will lead a matrixed cross functional team to enable

process and analytical clinical and/or commercial transfers, support and implement lifecycle changes, comparability, and support the start-up of new internal facilities.

He/she will participate in strategic discussions, anticipate bottlenecks, and transfer/ comparability risks, and address issues proactively, while fostering an environment of teamwork.

The person will be responsible for leading cross-departmental teams, planning risk assessments and strategy development for cell therapy robustness activities.

The person will collaborate with SMEs, user groups, quality groups, and other stakeholders to accomplish successful implementation of robustness initiatives including support process simulations, transfer lot generation, comparability studies, test plan generation, operator training, and troubleshooting.

The person will review and provide guidance on strategy in technical protocols and results in technical reports. This person will collaborate across all CMC functional areas to ensure project advancement, rapid and best in class execution, and communication of

challenges/opportunities.

The person will play a key role in product lifecycle management, including development, characterization, commercialization, and evolution of cell therapy products

Job Description:

Major job duties include:
Lead and Interface with manufacturing site operations teams and process/analytical SMEs to implement processes, procedures, and analytics by applying in-depth CAR-T manufacturing process knowledge
Promote innovative and efficient approaches to implementing robustness initiatives for commercial cell therapy products based on risk-based elements and considerations unique to cell therapy production
Coordinate project planning, timeline, communications, and risk management activities
Support manufacturing, QC and QA throughout transfer by providing training, answering questions, clarifying intent of procedures, solving problems, and contributing to operational strategies
Anticipate and address issues in manufacturing related to process, documentation, or training
Provide technical input and investigation support for deviations/OOS
Assist in the management of changes, and in the implementation of process improvements
Provide technical input in support of regulatory submissions
Interact with other CMC teams including Operations, QA, Development, and Regulatory
Foster strong inter-team relationships to achieve common project goals
Evaluate and assist in statistical design and execution of comparability exercises for cell therapy products
Review regulatory filings summarizing the technology transfer and comparability strategy and results
Contribute to alignment and harmonization of strategies across multiple sites and stakeholders

Basic Qualifications:

Degree in Biology, Chemistry, Biochemical or Chemical Engineering, or equivalent area of related experience in biologics upstream manufacturing: Master's degree with 12+ years or Ph.

D. degree with 10+ of experience.
Candidate should have an advanced degree in Cell Biology with in-depth knowledge on process and analytical methods.
Candidate should have the experience of lab start up, analytical automation and facility start up for cell therapy products.
Candidate should have extensive cell therapy manufacturing experience and have written Commercial Technical Product Descriptions and Control Strategy documents.

The candidate must have demonstrated verbal, written, and communication skills including ability to present complex information clearly and concisely, with a successful proven history of working with technical teams.

Experience should include strong knowledge and technical leadership and proven track record of managing

comparability/similarity

projects.
Established track record of success with technology transfers and change management in commercial establishment.
Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations.
Experience in development and/or characterization of biologics and/or cell therapy manufacturing processes
Demonstrated leadership skills, and the ability to interact with and lead diverse groups and teams are essential.

Proven project management skills (organization, collaboration, multi-tasking, and communication), attention to detail, and the ability to perform well in a cross functional team-based environment are required.

Prior experience in/knowledge of cell culture, viral vector manufacturing, recovery and/or purification of viral vector product in a manufacturing environment required.

Strong experience with SOPs, change controls, cGMPs and the know how to work within a regulatory environment required.
Prior experience

facilitating/participating

in Risk Assessments required.

Work Environment:
Position is primarily office based with occasional work in a classified GMP manufacturing environment
Position is a team & project-based position that will require occasional shift work, weekends, and holidays

Travel:
This position may require up to 25% of travel

The starting compensation for this job is a range from $178,000- $224,000 (if based in Devens, MA) and $182,000-$229,000 (if based in Seattle, WA), 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.

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.

W e're creatinginnovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.

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