CLS Services

Gepubliceerd: 14 dagen geleden

(Sr) Supervisor ELM/Automation

Leiden
Gepubliceerd: 14 dagen geleden
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CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, Janssen Biologics B.V., we are searching for a (Sr) Supervisor ELM/Automation.

Company profile
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.

They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.

Department
The Quality Control is a Business Unit within the Leiden Janssen Biologics site, a biotherapeutics and vaccines manufacturing site that is part of the Janssen Supply Chain. The Leiden QC Business Unit is responsible for raw material, in-process and release testing for products manufactured at the site. Additionally, Leiden QC has a unique global responsibility and exposure by being the stability testing hub for large molecule products within Janssen Supply Chain, and by partnering with multiple CMOs to perform the release testing. The business unit is structured in different testing laboratories and supporting departments, which are divided based on specific techniques and/or expertise. All test laboratories are supported by the Stability, NPI & New Technology department, for which this exciting position is open.

Job description
We are looking for a (Sr.) supervisor who will lead the ELM/Automation team (i.e. Lab system Build) , which has a key role in supporting new products and new technologies by introducing the required automation tools, laboratory systems and equipment. The team consists of approximately 10-14 FTE’s.

As (Sr.) Supervisor, your are accountable for the personnel in the Lab system Build team and their performance & development. Additionally, you are accountable for effective team performance by setting objectives in line with the ONE JSC Lab Organisation business strategy.

Tasks and Responsibilities:
Technical and job specific:

  • Ensure on-time delivery of validated software, lab system tools and equipment qualification to support new product introduction timelines, meeting cGMP requirements and safety regulations;
  • Primary accountability for the planning, organisation, day-to-day supervision and execution of daily tasks within the team;
  • Lead for Manufacturing of the Future activities within Leiden QC, including MFF deep dive assessment;
  • Ensure seamless transfer of activities to Life Cycle Management Automation/ELM team (i.e. Lab system Run);
  • Deal appropriately with any deviations and notifies impacted Leiden QC teams and management;
  • Improve automation and equipment introduction processes to ensure lean and timely introduction while keeping cGMP and safety standards;
  • Change Agent for introduction of new technologies and tools to allow more efficient work and onboarding new products;
  • Ensure the team is subject matter expert on automation and ELM processes and has a leading role during the GMP inspections;
  • Maintain oversight over the implementation of guidelines, regulations and global standards related to automation and ELM activities;
  • Participate in management meetings, joins the quality and DPDS network organisation and partner with customers (e.g. CMOs, JSC manufacturing sites, PQM, testing laboratories) to ensure flawless experience;
  • Support Business Planning and capital forecast processes within Leiden QC.


Managerial:
  • Mentor, coach, train and develop the personnel of the team. Evaluate performance and provide opportunities for growth;
  • Manage the planning and resource allocations of the team;
  • Create a team environment for continuous improvements and critical and creative thinking.



Compliance, Quality, Safety and Health:
  • Ensure that procedures and guidelines linked to safety and health are met;
  • Ensure that the group complies with the environmental procedures and guidelines;
  • Ensure overall compliance to regulatory cGMP requirements, global standards, procedures, etc.;
  • Ensure that data are generated and maintained according to current regulatory requirements.


Who we're looking for
The ideal candidate has a Master degree in chemistry or biotechnology, with 5-6 years of experience in the pharmaceutical industry.
Experience and skills:
  • Experience in Quality Control, Method development, validation, automation/ELM, etc.;
  • Profound knowledge of pharmaceutical regulations/cGMP principles (FDA, EU, JPN, etc.);
  • General knowledge of pharmaceutical development & manufacturing;
  • Organisational planning and problem-solving experience;
  • Strong leadership & development qualities;
  • Experience with principles of Process Excellence, Lean manufacturing, etc.;
  • Good presentation skills;
  • Experience in managing people (direct report lines, or indirect e.g. projects).


Additional vacancy information
Reference: A2000098
Contract: Temporary contract with CLS Services
Education: WO/MSc.
Terms: Project for at least 1 year.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555

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