Process Lead

16 August 2021
SalaryNegotiable
LocationAmsterdam, Gemeente Amsterdam, North Holland
Permanent
DisciplineLife Science Careers
ReferenceBBBH466892_1629121344

Wacker Biotech is a microbial CDMO (Contract and Development Manufacturing Organization). Our products extend from strain/process development and analytical testing through to production of clinical and commercial applications in compliance with good manufacturing practice (GMP).

Wacker Biotech has currently four production sites: Jena and Halle in Germany, Amsterdam in the Netherlands and a recently acquired site in San Diego in the USA. Wacker Biotech is a world-leading partner when it comes to the manufacturing of microbial biopharmaceuticals
The Amsterdam site has over 20 years of experience in producing microbial derived proteins and vaccines and extended production capabilities to include the modern mRNA-based vaccines. Currently we are supporting one of our customers to scale up the production of a Covid19 vaccine candidate - with an initial plan to produce 100 million doses.

We need you to play your part in producing these vaccines and proteins!
and that is why we are currently recruiting Process Leads (f/m/d) for our Bioprocessing I Team.

Besides being involved in production the Process Lead Upstream/Downstream Processing is involved in the introduction of the new client processes into the manufacturing organisation. This means writing process documentation, training, and coaching of operators on the execution of the process. You will be working on all our produced pharmaceutical products (vaccines, protein, polysaccharide and live microbial). This variation in activities and the fact that operators work in both the Upstream and Downstream part of the process make that you will work on a high amount of different systems and process steps.

Your tasks:

  • You are a Subject Matter Expert (SME) with respect to client projects and directly involved in scale up, writing process documentation, training, and coaching of operators on the execution of the process;
  • Execution of activities for GMP production such as buffer preparation, washing, build-up of sterile goods according to procedure and planning;
  • Execution of routine activities on the complex systems within the departments according to the procedures and planning;
  • Perform all process activities in accordance with FDA/GMP guidelines;
  • Ownership of their own training requirements (Basic Operator, additional training on topics such as deviations, review, writing documentation);
  • Ownership regarding Health & Safety. Following procedures, wearing proper safety gears, communicate unsafe or unhealthy situations. Initiates or revise procedures to improve Health and Safety environment;
  • You are a Subject Matter Expert (SME) with respect to production equipment and directly involved in maintenance, validation, and calibration of this equipment;
  • Takes initiative to complete internal projects or deviations within the agreed timelines.



Your profile:

  • At least an MBO/HBO level of education with relevant technical and at least USP/DSP process experience;
  • Quality-conscious, flexible, and proactive;
  • Experience in working under GMP guidelines;
  • Team player with a high degree of autonomy;
  • High priority on personal hygiene;
  • Analytical, accurate and structured;
  • Willing to work in shifts (three shifts from Monday to Friday);
  • Good Dutch and English written and oral communicative skills;
  • Experience in the (bio) pharmaceutical Industry;
  • You reside in and are eligible to work in The Netherlands (valid work permit).



Sustainability is one of WACKER's corporate goals - also as an employer. We want you to remain productive, healthy and successful long term. That is why we offer, for example, comprehensive health management and a variety of advanced training programs and courses for individual development opportunities, alongside a good work-life balance. Naturally, we also have a fair compensation system and above-average social benefits.

For more details contact our recruitment partner Kelly Services:
Sari Steenhauer - 0031 (0)6 33 13 77 46 -

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Regarding this role, Kelly Services acts as the official mediator. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement

In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.