Manager, Lab Planning & Operations
Manager, Lab Planning & Operations
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$ 111890 - 135600
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: Manager Lab Planning & Operations plays a critical role in supporting the execution of bioanalytical and Companion Diagnostics (CDx) programs within the PMBATS department. You will drive operational excellence for regulated bioanalytical studies and CDx development ensuring high quality compliance and timely delivery of internal and outsourced projects. This role coordinates cross-functional activities manages project timelines and deliverables supports resource and budget planning and ensures adherence to regulatory standards (GLP CLIA CAP ISOCFR Part 11 QMSR IVDR).
You will lead project coordination for clinical bioanalytical studies including oversight of critical reagents assay timelines and deliverables working closely with external CROs and internal cross-functional teams.
KEY RESPONSIBILITIES
Project Operations
Lead and coordinate regulated bioanalytical and CDx studies including CRO oversight assay transfer and validation sample/data logistics and discrepancy reconciliation to ensure timely compliant execution.
Provide bioanalytical project management for clinical studies managing critical reagents and timelines for deliverables.
Monitor operational risks and deviations and lead implementation of corrective and preventive actions (CAPAs) in collaboration with quality teams.
Cross-Functional Coordination
Work collaboratively with scientific technical quality regulatory IT finance and legal teams to drive successful lab operations and study execution.
Support the development and management of contracts and scope-of-work with research collaborators and external service providers.
Vendor & CRO Oversight
Serve as the primary liaison with CROs and external partners managing study milestones deliverables and compliance with BMS quality systems and regulatory standards.
Compliance & Quality
Collaborate with the Lab Compliance team to maintain personnel information training records and department SOPs.
Support training program execution for the bioanalysis team ensuring training compliance is maintained tracked and audit-ready.
Coordinate SOP lifecycle management including drafting reviewing updating and routing SOPs related to bioanalysis and CDx operations to ensure compliance with internal document control policies.
Documentation & Archival
Maintain and oversee archival processes and systems for submission maintenance and retrieval of documentation under GLP GCP 21 CFR Part 11 and internal SOPs.
Ensure version control traceability and long-term accessibility of critical documentation such as validation data study reports assay protocols and SOPs.
Financial & Resource Planning
Assist in planning and tracking of project budgets resource allocation and expenses in alignment with operational needs.
Project Reporting
Prepare and deliver operational updates and project status reports for internal leadership and cross-functional stakeholders.
Continuous Improvement
Champion best practices in lab operations and project management to drive continuous improvement and efficiency.
QUALIFICATIONS
Education & Experience:
Bachelors degree in a scientific or engineering discipline required; Masters degree preferred.
Minimum 6 years of industry experience in bioanalysis and/or IVD/CDx development within pharmaceutical biotech medical device or CRO settings.
Direct experience managing regulated bioanalytical operations and assay transfer/validation with CROs.
Practical knowledge of FDA QMSR GLP ISO13485 CLIA CAP and IVDR standards.
Experience with LDTs and diagnostic platforms including LCMS ligan binding assays is highly desirable
Skills & Competencies:
Strong grasp of laboratory operations diagnostic development and regulated bioanalytical workflows including PK/PD and diagnostic studies.
Demonstrated ability to manage multiple timelines and priorities in dynamic environments with a results-driven detail-oriented mindset.
Experienced in vendor oversight and contracting including CROs central laboratories and third-party service providers.
Skilled in project planning stakeholder alignment conflict resolution and cross-functional communication and negotiation.
Familiarity with financial tracking budgeting processes and contract development.
Proficient in QMS EDMS and document control systems supporting compliance and audit readiness.
Advanced user of MS Office and project management platforms.
PMP certification or formal training in project management is a plus.
The starting compensation for this job is a range from $111890 - $135600 plus incentive cash andstockopportunities(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 ourBMSCareer Site.
Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following:Medicalpharmacydental 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 insurancesupplementalhealthinsurance business travel protection and survivor support. Work-life programs include paid national holidays and optionalholidaysGlobalShutdown days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sicktime off and summer hours flexibility. Parental caregiver bereavement and military leave. Family care services such as adoption andsurrogacy reimbursementfertility/infertilitybenefits support for traveling mothers and child elder and pet care resources. Other perks liketuition 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:
Manager
Employment Type
Full-Time
