Manager Manufacturing Operation Drug Substance (f/m/d) – 100%

Plus d’informations et postuler

von: Kelly Services (Schweiz) AG | localité: BernN: KellyServices(Schweiz)AG

For a multipurpose biomanufacturing site in Lengnau BE, we are looking for a

Manager Manufacturing Operation – Drug Substance (f/m/d)
Temporary position, 100%

You will co-lead a manufacturing area (upstream, downstream, solution preparation and support) to ensure the operational activities to produce recombinant products.
You will support project teams in the design, commissioning, qualification and validation of new production lines for recombinant products.
You will support new product introduction for recombinant products.

Main responsibilities

  • Daily operations of upstream processes in manufacturing sites, including schedule, shift rotations
  • Leads and develops Manufacturing Team in order to run areas robustly and efficiently, ensuring appropriate succession planning
  • Participates in defining robust process parameters during routine manufacturing campaigns
  • Builds cross functional teams and interacts with other support functions such as QA, QC, MS&T, Engineering, Validation and other relevant functional areas
  • Works closely with the PMO, Engineering, Quality and Business Technology to support the design, procurement and commissioning of production equipment and automation systems in accordance with process requirements and compliance
  • Participates in technology transfer and operational readiness activities to implement new production processes and new lines
  • Supports CVQ, PQ, Process Validation execution
  • Ensures implementation of and adherence to current GMP rules, quality policies, procedures and instructions for area of responsibility
  • Ensures implementation of and adherence to EHS legal requirements, rules, policies, procedures and instructions for area of responsibility
  • Takes personal accountability for their presence, performance, and productivity for the achievement of defined objectives
  • Attracts and develops talent to deliver exceptional performance and achieve their full potential

Profile

  • Bachelor's or master's degree (e.g. in chemistry, biochemistry, biology, food science)
  • >10 years' experience in pharmaceuticals operations in a GMP relevant environment
  • Experience in biotech or pharma processes: 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
  • Required languages: English and German
  • Flexibility with regard to working hours

General information

  • Start of work: asap
  • Type of contract: temporary, for the time being planned for 1 year
  • Place of work: Lengnau, BE
  • Workload: 100%, on-site
  • Remarks: occasional weekend work according to need of production planning, potential shift work to be expected on occasion, on-call support

Your application

If you are interested in this position, please send your CV in English to Nicole Blum:

If you have any questions in advance, you can also contact us by phone:
Nicole Blum: +41 (0)79 204 36 85 or +41 (0)61 270 80 14

We look forward to hearing from you!

  • Bern

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