QC Team Lead

QC Team Lead, (f/m/d) 100%. Visp (VS), CH

Bacthera is leading contract development and manufacturing partner (CDMO) for biotech and pharma customers. We enable our customers to bring life-changing treatments to patients. We operate from our headquarters in Basel (CH) and have production facilities in Denmark and Switzerland. We bring together best-in-class, complementary capabilities and we are the first CDMO globally to provide a full supply chain that offers manufacturing of live bacteria strains for therapeutic use.

For our site in Visp (VS) we are seeking a motivated, open minded and experienced person as:

QC Team Lead (f/m/d) 100%

The QC Team Lead, a member of the Quality Control unit, is responsible for the Quality Control department including all analytical capabilities needed to support the manufacturing of LPBs. He/she must ensure that the analytical requirements are defined in compliance with emerging and established national/international requirements and GMP standards. He/she implements Quality Control capabilities that positively impact the quality strategy of the company. As QC Team Lead you will report to the Global Head of QC. He/she will be responsible for microbiology and physico-chemical labs.

Your Profile

  • Bachelor or master’s degree in pharmacy, chemistry, biotechnology or life science
  • More than 10 years of experience in the cGMP regulated pharmaceutical industry, preferably in a quality and compliance role in quality control
  • Strong background of QC laboratory processes and GMP requirements in clinical phase and commercial, is an asset
  • Strong leadership skills; very good communication skills and interaction with all kind of interfaces within the organization, customers and with health authorities (Swissmedic, FDA etc.).
  • Ability to prioritize and manage work to critical project timelines in a fast-paced environment
  • Good knowledge of analytical methods (e.g., microbial contaminant, qPCR, flowcytometry, enumeration) and Pharmacopeias (EP, USP)
  • Very good communication and negotiation skills in German & English
  • Structured, focused and well-organized working attitude; open-minded for new ideas and suggestions; agile, highly motivated and dynamic drive

Role and Responsibilities

  • Acts as Quality Control Team Lead
  • Build/Recruit the team of highly skilled specialists/analysts, with the right flexibility and competences, able to handle multiple products/ analysis, in close interaction with Bacthera’s customers and the rest of the organization
  • Establishes and reviews documents, procedures, methods and specifications that impact identification, strength, quality, and purity of raw & packaging materials, Cell Banks, Drug Substances and Drug Products
  • Responsible for raw & packaging material management relevant to sampling, testing and release to production
  • Responsible for the release of Cell Banks, DS, DP according to relevant analytical procedures and specifications.
  • Responsible for stability management of Cell Banks, DS, DP relevant to defining stability study, storage of samples, and testing
  • Has the oversight of analytical testing conducted as in-process control and all analytical activities delegated to production
  • Responsible for retain/reference samples management according to regulatory requirements
  • Responsible to ensure Validation and transfer of Analytical Method processes are in place and properly executed
  • Ensures that QC lab equipment is properly qualified and maintained according to company’s internal requirements
  • Responsible for environmental monitoring program by reviewing and assessing the results and trend reports
  • Ensure that errors, out-of-specification analyses, deviations, change request, and quality complaints related to analytics are investigated and documented; assist in determining appropriate CAPA; and communicate with internal and external stakeholders
  • Define the required analytics and the acceptable limits, where the pharmacopeias do not provide guidance
  • Participates regulatory inspections and client audits as well as audits to external labs or as required
  • Trains and supervises staff and works cooperatively with Bacthera leadership to achieve quality and compliance goals
  • Set the Quality Control strategy and direction across cell bank, drug substance, drug product, raw materials, excipients, packaging materials analytics together with Development and Operations
  • Ensures a thorough information exchange from other management levels to his/her team and leads by influence and collaboration in relevant business areas and works in a matrix environment to reach effective decisions
  • Implements the Bacthera culture via openness for change and new ideas, cooperative teamwork and continuous improvement even outside his/her own area of responsibility. Implements a vision as important contributor to the organization’s success
  • Ensures and manages the respective interfaces to the Manufacturing teams, QA, Support Functions, Project- and Site Engineering

Are you interested to work for an innovative, dynamic and future oriented start-up company? Are you looking for a new challenging role where you can create things and leave your footprint? If you can answer those questions with YES, then send us your full application to Ms. Sandra Gamboni, Global Head of Human Resources; HR@bacthera.com.