Pharma

Pharma

Car-T Operations Technical Lead -Clean Room

9052 ZWIJNAARDE
Optie vast contract
Bachelor
35 u/week
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Functieomschrijving

The Operations Technical Lead Clean Room is an exempt-level position within the Technical Operations team, responsible for coordinating specific aspects of daily personalized cell therapy production in a sterile cGMP environment. This role involves leading and co-executing process operations, ensuring compliance with standard operating procedures, and maintaining a safe manufacturing environment. The Technical Lead Clean Room will collaborate with cross-functional teams to address production issues, support quality aspects, and contribute to continuous improvement initiatives.

Responsibilities:

  • Lead CAR-T process units, ensuring SOP and cGMP compliance.
  • Build partnerships with cross-functional teams, addressing production issues.
  • Manage quality aspects, review documentation, and act as an SME for audits.
  • Communicate KPIs related to quality in Production.
  • Provide guidance on the production floor, supporting Tech Transfer plans.
  • Contribute to process development and continuous improvements.
  • Assist in investigations and personnel training.
  • Lead daily shift meetings, assign tasks, and collaborate for personnel development.
  • Ensure safe and compliant manufacturing operations within a team environment.

Profiel

Requirements:

  • Bachelor’s or Master’s degree in Science, Bio-Engineering, Pharmacy, or related field, or equivalent experience.
  • Minimum 2 years of operations experience in cGMP or ATMP environments.
  • At least 2 years of aseptic/grade C GMP manufacturing experience.
  • Minimum 1 year of team or project leadership experience.
  • Familiarity with cGMP regulations, EMEA guidance for cell-based product manufacturing, and cleanroom behaviors.
  • Strong leadership, communication, and influencing skills.
  • Ability to work independently, prioritize tasks, and manage multiple responsibilities.
  • Organizational skills for managing shifting priorities in a dynamic environment.
  • Analytical, problem-solving, and pragmatic critical thinking skills.
  • Positive "Can-Do" attitude, Right-First-Time mentality, and hands-on approach.
  • Tenacity to drive issues to resolution and deliver results.
  • Self-motivated, enthusiastic team player with a desire to learn and train juniors.
  • Clear verbal and written communication skills with attention to detail.
  • Proficiency with Microsoft Office tools required; MES/EBR proficiency is a plus.
  • Willingness to work shifts, including evenings, weekends, and unplanned overtime.

Aanbod

  • You will join an exciting pharmaceutical company with opportunities for growth.
  • You will work within a strong and respectful diverse team where everyone is welcome.
  • You will receive an attractive salary package including meal vouchers and eco vouchers.
  • Hospitalization insurance, group insurance and bonus are part of the package.
  • You work in a 2-shift system (6h - 16h / 14h - 00h) in a regime in which you work 4 days, have 4 days off, etc. This gives you a good balance between work and private life.
  • You will work in an environment where loyalty and team spirit are highly valued.

Bedrijfsinfo

Onze klant, een biotech bedrijf, gevestigd in Zwijnaarde, is een wereldwijd biotechnologiebedrijf dat de innovatieve celtheraptie naar Gent brengt. Het team maakt hiermee dagdagelijks het verschil in het leven van vele patiënten die lijden aan kanker en andere levensbedreigende ziektes. Ze zijn momenteel in een fase van sterke groei en zoeken gemotiveerde en toegewijde teamleden. 

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Start People Gent GT
+32 (0)9 269 37 20
gent@startpeople.be
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