A fast-growing biopharmaceutical company is seeking a Microbiology QC head (w/m/d). You will be leading the QC microbiology team, serving as a technical expert for microbiology and environmental monitoring, being a point of contact for project coordination, and having experience in leading and guiding teams. The ideal candidate should also be comfortable working in a fast-paced environment and be able to adjust their workload based on changing priorities.
Your responsibilities:
* Responsible for Microbiology & EM Department
* Coordinate tasks to meet project timelines
* Lead or participate biologics product projects, including in-process testing, microbial testing, environmental monitoring, viable and non-viable particles, water monitoring, compressed gas (Air and N2), pure steam, and supporting facility qualification, process validation, etc.
* Serve as a technical expert for Microbiology & EM and lead OOS, OOL, microbial contamination, adverse trends, utility and environmental excursion investigations, change controls, and CAPAs
* Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
* Provide technical expertise, trouble-shooting, training and support to the laboratory team in the qualification and execution of environmental monitoring and microbial testing
* Support other areas as manufacturing to improve training related to microbiological hygiene and contamination prevention
* Point of contact for project coordination, including email and client meetings
* Represent the Department during regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits
* Perform job specific tasks in compliance with applicable Regulations, International Standards, and company Policies and Standard Operating Procedures.
Your profile:
* Bachelor, Master or Ph.D. degree with major in Analytical Chemistry, Biochemistry, Microbiology, Biology, Molecular biology, or Biological Engineering field
* Ph.D. with minimum 3 years, MS with minimum 7 years, BS with minimum 10 years of microbiology experiences in pharmaceutical industries
* Experience in Pharmaceutical/Biopharmaceutical industry
* Experience in a Quality Control Experience in GMP and profound knowledge in FDA, EMA regulations and ICH and GMP guidelines
* Experience in leading and guiding teams
* Able to create and motivate a team
* Excellent Oral & Written communication skills (English and German)
* Ability to think critically and demonstrate troubleshooting and problem solving skills
* Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities
