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

Description

**Working with Us**

Challenging. Meaningful. Life-changing. Those arent 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. Youll 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: .

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, theres 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: Masters 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 Years 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 doesnt 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.

**Company:** Bristol-Myers Squibb

**Req Number:** R

**Updated:** :15:14.008 UTC

**Location:** Summit-NJ

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.