Technical Fellow, Cell Therapy Platform

Bristol Myers Squibb Seattle , WA 98113

Posted 1 week ago

Apply

This Job is not relevant Tell us why

At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

PURPOSE AND SCOPE OF POSITION:

We seek a Technical Fellow to leverage her/his considerable technical knowledge and broad industry-wide expertise to shape BMS' stem cell-based cell therapy platform processes to support BMS' allogeneic gene-engineered therapy portfolio. The Technical Fellow will serve as BMS' internal subject matter expert on pluripotent cell production platform technologies and will derive the vision and strategic rationale for short- and long-term goals, which must fit within BMS's cell therapy ambitions. As part of the role, the Technical Fellow will create the roadmap for best-in-class pluripotent stem cell platform design and advise, consult, and mentor process development and integration project teams. The incumbent will be responsible for creating an innovative and realistic vision for our stem cell-based platform that must address many engineering areas across cell characterization and pluripotency maintenance, cell differentiation and reprogramming, genetic engineering, and large-scale expansion and product formulation. Additionally, the Technical Fellow is expected to write white papers and external publications and support drafting and assembling regulatory documentation in preparation for clinical trials and commercialization. Ultimately, this role will provide the necessary technical and strategic expertise required to realize robust manufacturing processes for IND and commercial-enabling production scales. The Technical Fellow will work closely with the respective technical lead, who manages the execution of BMS's stem cell work, and the Allogeneic Platform Lead, who oversees BMS's technical implementation of allogeneic cell therapy projects.

The ideal candidate has professional industrial experience in pluripotent stem cell biology and commercial-scale design and is a well- regarded expert on gene-engineered stem cell-based production platforms. As a thought leader, the Technical Fellow will be a cross- functional matrix leader without direct reports but is expected to steer our allogeneic platform development and technology teams. The incumbent will bring their considerable expertise across multiple technical fronts to support business development efforts and must be adept at creative problem solving and innovation.

RESPONSIBILITIES:

Leverage considerable experience to design a multigenerational pluripotent cell technology and production roadmap to support
clinical trials and commercial launch, within the rigors of BMS' portfolio needs.
Consult and advise lab-based project teams on process design, technology integration, and study execution. Serve as an
inspiring and motivating matrix leader.
Partner with engineering teams to design testable hypotheses, prioritize experiments, and review data. Provide insights to
maximize the chance of success and mitigate risks.
Draft and publish technical documentation, including white papers, risk assessments, technical reports, external publications,
invention disclosures, due diligence reports, and provide regulatory filing support.
Assist with strategic planning across the allogeneic cell therapy portfolio.
Leverage strong verbal and written communication skills to provide regular updates to senior leaders, technical governance and
other stakeholders.
Serve as a force multiplier for BMS' allogeneic cell therapy engineers, scientists, associates and staff.

EDUCATION AND EXPERIENCE

Advanced degree in immunology, biotechnology or related discipline required, Ph.D. is preferred; industrial product/process
development in stem-cell based production systems with demonstrated experience is required (15+ years)
Documented track record of innovation and industry-wide expertise in stem cell biology, genetic engineering or reprogramming,
mammalian cell culture and differentiation into different cell species.
Proven success in optimizing commercial-scale bioreactor platforms for stem cell-based therapies or other stem cell-based
approaches.
Experience in gene editing approaches (e.g. Crisp/Cas9) or leukocyte biology highly desired
Must be a visionary thought leader with a strategic mindset and an understanding of technological and scientific trends across
the stem cell therapy space.
This position can be fulfilled in a remote work setting.

If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

BMSCART

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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.

Show Full Description

See how you match
to the job

Upload my resume

Download the
LiveCareer app and find
your dream job anywhere

Similar Jobs

View All

Want to see jobs matched to your resume?
Upload One Now!

Technical Program Manager II Platform

Twitter

Posted 3 days ago

VIEW JOBS Technical Program Manager II- Platform Locations Seattle, San Francisco, New York City, Remote US This role accepts applications for work in the locations as noted above. Roles listing 'Remote US' as a location are not currently available in the following states: Colorado, Iowa, and Louisiana. Company description TPM at Twitter is a centralized team staffing a diverse bench of industry leaders working across all orgs in the company. As a Revenue TPM, you will be responsible for driving the future of Twitter's advertising products, tools, and platforms, while leading cross-functional initiatives that span the breadth of engineering activities at Twitter. Job description Who We Are Lead cross-functional delivery of strategic technical initiatives across the company, serving Twitter's platform. The Technical Program Management Platform team leads operations and delivery of Twitter's highest priority cross-functional initiatives, enabling Twitter's Engineering teams to thrive and scale. TPM at Twitter is a centralized team staffing a diverse bench of industry leaders working across all orgs in the company. As a Platform TPM, you will be responsible for driving the future of Twitter's platform, from cloud migrations and datacenter expansions, to improving privacy and data protection tooling, to engineering effectiveness tools and platforms. Who You Are * Experienced cross-functional lead with a solid track record partnering with product teams to define strategy and requirements * Proficient collaborating with engineering teams to design, scope, and deliver high scale services within distributed systems * Consistently trusted leader, able to drive large teams and executives through complex, multi-faceted data-driven decisions * As a generalist and outcomes owner, you have the ability to fill any gap needed to deliver, including writing functional specs, project / release plans, roadmaps, and technical proposals * Thrive amid ambiguity, able to influence peers / managers toward shared vision and forward progress * Tireless multitasker, with capacity to own and execute multiple large programs simultaneously * A role model, coach and mentor to others, with an eye on team productivity and helping others succeed. What You'll Do * Lead strategic alignment and technical delivery of company-wide initiatives in support of Twitter's Platform * Partner with all program stakeholders and lead execution from strategic objective to delivery * Increase overall effectiveness of our platform organization by systematically identifying and solving root cause organizational and technological challenges discovered through the course of program delivery * Partner with Engineering Managers and Strategy & Operations to ensure teams meet their schedule targets by implementing industry best practices in program and project management and roadmap delivery, creating novel solutions where appropriate. * Partner with leadership and technical leads to deliver solutions that meet engineering and business requirements Qualifications Qualifications Requirements * Bachelor's degree or higher in computer science / engineering, or equivalent work experience * 2-5+ years as a TPM, engineering leader, product manager (technical domain), or related discipline * Experience working with several different development methodologies and productivity tools * Consistent track record of shipping products at scale, with broad customer impact * Experience building or managing work on highly-available, scalable software products and services * Proven ability to identify and resolve systemic issues in both software and people systems * Interest and capacity to mentor TPMs and champion growth * Passionate interest in Twitter's products and mission Additional information We are committed to an inclusive and diverse Twitter. Twitter is an equal opportunity employer. We do not discriminate based on race, ethnicity, color, ancestry, national origin, religion, sex, sexual orientation, gender identity, age, disability, veteran, genetic information, marital status or any other legally protected status. San Francisco applicants: Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records. Engineering hiring process Step 1 Once your application is received, a recruiter will reach out pending your qualifications are a match for the role. Step 2 If your background is a match, you may have 1-2 technical phone interviews or be given the chance to provide a work sample depending on the role. Step 3 If the phone interviews go well or your work sample is strong, the final step includes interviews with 5-6 people via a video conference call.

Sr Director Global Validation And Tech Services Cell Therapy

Bristol Myers Squibb

Posted 2 weeks ago

VIEW JOBS At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS's continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible. Come and join Celgene for this key leadership role to be part of the team building a leading CAR T Platform that serves our patients with novel Celgene CAR T Therapies. At BMS, we are developing novel cellular immunotherapies based on two distinct and complementary platforms - Chimeric Antigen Receptors (CARs) and T Cell Receptors (TCRs) technologies. Our goal is to revolutionize medicine by re-engaging the body's immune system to treat cancer. This role will report to the Vice President of Cell Therapy Global Manufacturing Science and Technology and is a key leadership role within BMS Cell Therapy Development and Operations (CTDO) Division. Reporting to this role will be team leaders/SMEs responsible for various sub-functions such as gene delivery/editing validation, drug product process engineering, packaging and shipping validation, labeling and global automation. Role will also have a dotted line oversight of validation activities managed by the site MSAT validation leads across cell therapy manufacturing network to ensure harmonized approach. This senior leadership role will lead validation programs across the entire manufacturing network in CTDO (Cell Therapy Development and Operations) covering process, equipment and various supporting elements of manufacturing validation. The scope will range across all cell therapy products in the portfolio, internal and external manufacturing processes/facilities for the plasmid, viral vector and drug product. The process responsibilities include developing process validation standards, process qualification strategy and framework for cell therapy processes, continuous process verification (CPV) strategy and implementation in a consistent manner across products and sites and ensuring that these standards are reflected in the quality system. The equipment validation responsibilities include developing validation standards, framework for harmonized validation strategies for similar equipment and unit operations across plants and IQ and OQ activities during the commissioning stages of new equipment. This team will also support validation activities needed during design and build of new manufacturing plants to make sure the engineering approaches consider our harmonized validation framework that is complaint with the global health authority expectations and scientifically sound. This leader is expected to work across various CTDO functions, internal and external manufacturing sites and collaborate closely with local MSAT validation groups, quality and regulatory functions to shape the process, equipment and validation program and policies that are harmonized and defendable with the global health authorities. Furthermore, this leader will interface with the validation counterparts in the BMS Biologics and small molecule network to leverage expertise and knowledge across modalities. Candidate is expected to participate and network in the external industry forums and conferences to influence and contribute to the evolution of cell therapy manufacturing and validation practices. The head will develop a team of technical experts who understand the cell therapy manufacturing process to develop fit for purpose and scientifically sound validation strategies. In addition to developing strategies and standards, the team will participate in execution activities across the network to ensure expertise is integrated within the different work centers and our validation standards and master plans represent the continuous learning from the manufacturing experience. The scope of this group also includes packaging, shipping validation and commercial labeling for late stage clinical programs, launch and commercial operation. This head will also establish global automation function the scope of which will evolve as we commercialize our first CAR T products. This scope will include development of automation lifecycle guidance standards and policy, establishing data gathering systems and repositories across sites and products, leading and contribute to projects focused on the design, development, and qualification of automated processes, equipment, and systems into GMP manufacturing Job Description: Major job duties include: * Lead, develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations, industry standards and industry practices for cell therapy. * Promote innovative and efficient approaches to validation incorporating risk-based elements and considerations unique to cell therapy production. * Lead, develop and implement the master validation plans for process, equipment and facilities, in collaboration with the validation and technical SME network. * Develop and guide process validation, qualification and process monitoring strategies and framework. * Guide the teams to storyboard and present cell therapy global validation framework, standards and approaches during major health authority inspections. * Shape and review the technical content in the validation sections of the dossier * Support Quality and IT for validation of computer systems, as needed * Provide validation expertise for issue resolutions to support deviations or CAPAs and audit findings * Develop/approve cGMP documents including, but not limited to, Master Validation Plans, protocols. * Collaborate with QA to monitor and respond to audit observations related to GXP regulations * Work with MSAT network, to assess impact of changes to facility/processes validated state * Mentor a team of validation engineers and professionals and enable their individual growth * Establish performance goals and strategic/operational objectives for direct reports * Track department performance metrics and provide progress reports to stakeholders * Lead global validation team providing oversight of internal programs and with direct responsibility for validation activities at contract manufacturing organizations, including validation gaps assessments during CMO selection and tech transfers * Provide oversight via review and approval of network site level deliverables, including Validation Master Plans, process validation protocols and risk assessments. * Design qualification strategies to support novel applications of fill, filtration, sterilization and single-use disposable technologies * Facilitate harmonization amongst sites and adoption of industry best practices * Partner with Quality Assurance to maintain high standard of compliance in all program deliverables. * Work closely with process and analytical development and MSAT network during process characterization and validation stages of the late stage development to ensure that the process validation framework is consistent with our overall strategy * Expand automation lifecycle to enable phase appropriate implementation, realizing benefits of technologies in manufacturing network Basic Qualifications: * Bachelor's degree in a life sciences or Chemical Engineering discipline and a minimum of 15 years of relevant biotechnology or pharmaceutical industry (operations, technical development, MSAT) * 10+ years of direct experience in GMP validation activities, and 7+ years of people management * Proven record with successfully managing validation programs in support of GMP operations * Experience leading regulatory inspections regarding validation * Extensive knowledge of regulations, current industry practices, and experience with interpretation and application of guidelines and regulations * experience with Quality Management System (e.g. Deviations, CAPAs, Change Management) * Strong leadership track record especially in the areas of leading in a global and matrix environment, working cross functionally and developing strong technical talent * Excellent written and verbal communication skills at all levels in the organization Preferred Qualifications: * 2-3 years of experience in cell therapy process development and or manufacturing. * Combination of experience in process development, MSAT and quality. * Experience with manufacturing automation systems/platforms If you want to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients' lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today. BMSCART Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. 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.

Cell Therapy Associate Science & Technology (Activate Program)

Bristol Myers Squibb

Posted 2 weeks ago

Apply