USP Manufacturing Team Leader

The state-of-the-art multi-purpose manufacturing facility is crafted for large-scale production of biologics and has high expansion potential. After completion of construction activities, our site in Lengnau will offer highly flexible biomanufacturing technologies, from development to large-scale production including stainless steel equipment to meet our customer needs.

Purpose

• This position leads a manufacturing team (shift in upstream, downstream, solution preparation and support) to ensure the operational activities for the production of recombinant products
• This position supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products
• This position supports New Product Introduction for recombinant products

Responsibilities

• Is responsible for the daily operations of their shift in manufacturing suites, including daily schedule, shift rotations
• Lead and develop team members in order to run areas robustly and smoothly, ensuring appropriate succession planning
• Participates in defining robust process parameters during routine manufacturing campaigns
• Build cross functional teams and work well with other support functions such as Quality Assurance, Quality Control, Manufacturing Science and Tachnology, Engineering, Validation, and other relevant functional areas
• Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their interpersonal unit to continuous quality improvement initiatives and deviation reporting and follow-up.
• Ensures implementation of and adherence to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility.
• Ensures contribution of their interpersonal unit to EHSS initiatives and issues as well as near miss reporting and follow-up.

Qualifications

• Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
• 5-7 years successful experience in pharmaceuticals operations in a GMP relevant environment
• The function requires experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
• Good knowledge and competence in the field of automated processes
• Experience in leading teams
• Language: English or German
• Shift work is expected
• On-call support