(Sr) Supervisor ELM/Automation
It's a biotech company that focuses on the development, production and marketing of vaccines, recombinant proteins and antibodies to prevent and combat infectious and other diseases.
The (Sr.) Supervisor is accountable for the personnel in Lab system Build team and their performance & development by performing the 5 conversations. Accountable for effective team performance by setting objectives in line with the ONE JSC Lab Organization business strategy.
- Ensures 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, organization, day-to-day supervision and execution of daily tasks within the team
- Ensures seamless transfer of activities to Life Cycle Management Automation/ELM team (i.e. Lab system Run)
- Deals appropriately with any deviations and notifies impacted Leiden QC teams and management.
- Improves 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 on-boarding new products
- Ensure the team is subject matter expert on automation and ELM processes and has a leading role during the GMP inspections.
- Maintains oversights 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 organization and partners with customers (e.g. CMOs, JSC manufacturing sites, PQM, testing laboratories) to ensure flawless experience.
- Supports Business Planning and capital forecast processes within Leiden QC
- Master’s degree in chemistry & biotechnology or equivalent by experience with 5-6 years’ experience in the pharmaceutical industry.
- 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
- Organizational planning and problem-solving experience
- Strong leadership & development qualities
- Experience with principles of Process Excellence, Lean manufacturing, etc.
- Good presentation skills
- Excellent knowledge of English
- Experience in managing people (direct report lines, or indirect e.g. projects)