Associate Director, Technical Operations Validation Lead
Associate Director, Technical Operations Validation Lead
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$ 166000 - 208000
1 Vacancy
Job 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. 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: Summary
Director of Validation Cell Therapy Technical Operations reports to the Senior Director Cell Therapy Technical Operations within the Cell Therapy Development and Operations (CTDO) organization. This Technical Leadership role will provide Technical oversight to drug product and vector sites covering process validation for commercial cell therapy products manufactured globally via internal and external manufacturing sites.
This role will serve as the Global Technical SME for Drug Product and Vector Validation. The lead will develop global technical standards for cell therapy validation and deploy the standards to site MS&T at internal and external sites. The validation lead is accountable for developing equipment facility and process validation standards. This person is also responsible for qualification strategy and framework for all cell therapy processes continuous process verification (CPV) strategy and implementation of these programs in a consistent manner across all products in the network. Given the broad scope of validation for the expanding cell therapy global network this role will work across the broader CTO organization to ensure alignment of priorities develop a strategic vision.
The Cell Therapy Validation Lead will cover process equipment and supporting elements of manufacturing validation for all cell therapy products in the portfolio internal and external manufacturing processes/facilities for the plasmid viral vector and drug product. The person will own the accountability for the Validation function by providing oversight of all the validation activities including providing SME assessment for proposed process life-cycle changes. The lead will serve as the Global Point of Contact for sites and will work with the sites to provide oversight and drive activities utilizing site personnel.
This role will also support validation activities needed during the design and build of new manufacturing plants to make sure the engineering approaches consider our harmonized validation framework that is compliant with the global health authority expectations and scientifically sound.
Key Responsibilities
Lead develop and implement scientifically sound and fit for purpose validation standards and procedures based on current regulations industry standards and industry best practices for cell therapy.
- Create maintain and deploy global cell therapy validation technical standards via the quality system.
- 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.
- Serve as global consultant for update and revision of existing site validation master plans.
- Develop and guide process validation qualification and process monitoring strategies and framework.
- Guide the teams to storyboard and present the cell therapy global validation framework standards and approaches during major health authority inspections.
- Ensure timely technical support for validation-related questions for routine manufacturing lifecycle process changes quality audits and health authority inspections.
- Provide oversight via review and approval of network site-level deliverables including Validation Master Plans process validation protocols impact assessments and risk assessments.
- Author or review CMC summaries of validation for worldwide regulatory submissions for initialization and life-cycle changes.
- Design qualification strategies to support novel applications of fill filtration sterilization and single-use disposable technologies.
- Facilitate cell therapy harmonization for existing manufacturing sites and adoption of industry best practices.
- Work with process development and analytical development to ensure early pipeline assets have a robust process for future validation when in pivotal trials.
Qualifications & Experience
- B.S/MS.S/Ph. D in Chemical Engineering or Life Science with 12 years of relevant experience in the biopharmaceutical company with most of that experience demonstrating progression of leadership responsibilities and scope.
- Previous experience should be a combination of technical operation functions such as manufacturing quality MS&T or Technical Development. At least 10 years of direct experience in GMP environment is necessary.
- The leader should have the ability to define the right processes for the teams maturity level balancing agility and discipline. Career track record and industry reputation should be competitive at the highest level among industry peers.
- Leader should have demonstrated the skill to lead large complex technical organizations with a global scope and build people processes and technology in a growing organization. Strong leadership track record especially in the areas of leading in a global and matrix environment working cross-functionally and developing strong technical talent Leader should have excellent communication skills and be able to strategically influence the direction of the company in the scope areas mentioned above. This leader will have strong leadership values and be an internal and external facing ambassador of the company in the stated areas of scope in this function. Experience leading regulatory inspections regarding validation and extensive knowledge of regulations current industry practices and experience with the interpretation and application of guidelines and regulations.
- Experience with Quality Management System. Additional 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/platform
The starting compensation for this job is a range from $166000 - $208000
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 the geographic location where work is performed. Final individual compensation is decided commensurate with demonstrated experience. For more on benefits please visit our BMS Careers Site. Eligibility for specific benefits listed therein may vary based on job and location.
Benefitofferingsare subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical pharmacy dental and vision care. Wellbeing supportsuch asthe 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 -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 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 a supportive culture promoting global participation 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 an 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 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.
If you live in or expect to work from Los Angeles County if hired for this position please visit this page for important additional information: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Required Experience:
Director
Employment Type
Full-Time
