Technical Lead Manufacturing, Cell Therapy, Leiden

Working with Us Challenging. Meaningful. Life‑changing. Those aren’t 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. You’ll 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.

Location Netherlands: Utrecht and Leiden Bio Science Park, The Netherlands.

Position Summary Our Technical Lead performs 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.

Duties / 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 lead 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

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 / Experience / Licenses / Certifications

Associate or bachelor's degree in related field is preferred.

A minimum high school diploma and/or equivalent combination of education and experience is required.

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

Working Conditions

Must be able to stand/walk for extended periods of time

Must be able to work in a cleanroom environment and perform aseptic processing in ISO 5 biosafety cabinets, which require gowning and personal protective equipment (PPE), including by not limited to safety shoes, safety glasses, aprons, face shields, powered air purifying respirators (PAPR), lab coats, full body gowns, hairnets, gloves, and hearing protection

Required to carry and/or lift up to 30 pounds / 15 kg, several times a day, while handling production equipment and/or materials

Required to push and/or pull up to 50 pounds / 15 kg, several times a day, while handling production equipment and/or materials

Work in areas that may have strong magnets

Must be able to work in a BSL2/ML1 work environment handling human blood components

Work in areas with exposure to vapor phase liquid nitrogen

Must be able to work assigned shift (Day, Evening, Night, Weekends and/or Holidays)

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