Technical Lead Manufacturing, Cell Therapy

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:
Our Technical Lead perform a crucial role in driving our novel cell therapy programs by supporting routine manufacturing operations. We are searching for innovative intellectually curious individuals with a general understanding of Good Manufacturing Practices (GMPs) to support routine manufacturing operations for Cell Therapy. Successful candidates must be goal-oriented and flexible with the ability to work effectively and efficiently on a team while demonstrating safety quality and GMP compliance at all times.

Responsibilities:

Execute operations described in Standard Operating Procedures (SOPs) and batch records
Lead the matrix FLS (frontline support team) a cross departmental team (QA QC F&E IT MFG MSAT SC&L)
Responsible for schedule adherence cycle time and issue resolution. Report variances and communicate/mitigate impact to cross functional groups
Own deviations and leads investigations / CAPA development
Qualified as a deviation Lead investigator responsible for medium and high complex investigations across all manufacturing unit operations.
Lead investigator (medium and complex investigations >technical compliance and EHSS investigations)
Qualified trainer for all GMP operations closed and open operations including all grade B aseptic handling.
Owner of GMP documentation controlled documents and batch records.
Responsible for manufacturing operating procedures that are technically sound promote effective and efficient operations and comply with cGMP requirements
Solve complex problems; takes new perspectives using existing solutions. Operational trouble shooting
Production planning to execute daily unit operations schedule that includes people product and material flow across multiple shifts as needed
Maintain manufacturing environmental conditions (Non-Viable Particulate(s) and Viable microbial levels per controlled area classification specifications) by performing area disinfection regiment as required to meet global Health Authority requirements
Demonstrate a strong practical and theoretical knowledge in their work and guide team members in issue resolution
Execute operations described in Standard Operating Procedures (SOPs) and batch records
Executes transactions and process in all electronic systems
Demonstrate a strong practical and theoretical knowledge in their work
Perform tasks in a manner consistent with the safety policies SOPs quality systems and GMP requirements
Complete training assignments to ensure the necessary technical skills and knowledge
Proficient in process systems and supporting business systems

Setting up manufacturing areas and equipment/fixtures as needed

Collaborate with support groups on recommendations and solving technical problems.
Ensure the shift works effectively in a team based cross-functional environment to complete all production tasks required by shift schedule
Collaborate closely with Managers to ensure seamless pass down and communication of operational status
Completes change actions for change controls or investigations
Initiates and facilitates triage calls
Identify and propose innovative solutions
Drive right first time (RFT) execution of manufacturing unit operations by providing direct training guidance and problem solving
Aid in daily work coordination and distribution as demanded through the production schedule
Ensure shift notes and hand over communication is complete and accurate as needed
Leads Tier 1 and Tier 2 meetings
Delegate for manager
Drives positive attitude in team

Qualifications

Education:

MBO 3 of 4 in science related field and/or equivalent

Experience:

4 years of cGMP cell therapy manufacturing bioprocessing manufacturing or relevant experience and education
Extensive knowledge of cGMP regulations and FDA guidance applicable to cell therapy manufacturing
Peer-level on the floor leadership experience which demonstrates proficiency and compliant schedule adherence is highly desired.
Demonstrated aptitude for engineering principles and manufacturing systems.
Demonstrated proficiency in common computer tools such as word processing spreadsheet and web-based applications.
Demonstrated good interpersonal skills is attentive and approachable.
Maintain a professional and productive relationship with area management and co-workers.

Preferred Experience:

Experience in cell therapy manufacturing including Cell washing processes and automated equipment. Cell separation techniques and automated equipment. Cryopreservation processes and equipment.

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.