Head of Qualification and Validation

Head of Qualification and Validation (f/m/d) 100% – Basel, CH

We combine best-in-class capabilities from our two founding partners, including extensive know-how in developing, upscaling and manufacturing live bacteria, strong capabilities in pharma contract manufacturing, and outstanding formulation and drug delivery technologies, including the unique enTRinsic™ capsules.

Bacthera operates from its headquarters in Basel (CH) and has development and production facilities in Denmark and Switzerland. Bacthera is the first contract development and manufacturing organization (CDMO) to provide a full supply chain that offers manufacturing of live bacteria for therapeutic use for biotech and pharma customers.

For our site in Basel we are seeking a motivated, open minded and experienced person as:

Head of Qualification and Validation (f/m/d) 100% Basel, CH

We are looking for a motivated and experienced candidate to join our Operations team to support us in managing all validation and qualification activities across our sites in Copenhagen and Basel where we manufacture live biotherapeutic drug substance and drug product.

Your Profile:

  • A Master (minimum) or PhD degree in a relevant life science or engineering field or similar.
  • Min. 5 years’ experience in the GMP regulated pharmaceutical industry, preferably in the life science or biologics sector.
  • Experienced in supporting and-or leading facility and equipment qualification activities.
  • Experienced in cleaning verification and validation.
  • Preference: Experienced in process validation.
  • Preference: Proven experience in working with Lean tools.
  • Experienced in and comfortable with Health Authority GMP inspections (e.g. EMA, Swissmedic, US-FDA) and external (customer) audits.
  • Excellent collaboration and communication skills.
  • Proactive, solution-oriented team-player.

Role and Responsibilities

Equipment and Facility Qualification

  • Function as the lead and SME for qualification within Bacthera.
  • Works closely with the manufacturing departments and Quality organization, to prepare and deliver the site’s validation and qualification plan in accordance with our company policy, current industry guidance and practices.
  • Working with the manufacturing teams in the introduction of new equipment or capabilities to our GMP facilities and associated documentation.

Process and Cleaning Validation

  • Function as the lead and SME for product related validation activities, including process validation, cleaning verification and validation, transport validation. This will cover the range of products we make on behalf of our customers in our multi-product facilities.
  • Working closely with Quality, Development and Manufacturing Scientists on preparing validation plans and strategies for our customer programs.

General Operations

  • Support to production in response to major or critical deviations observed during manufacturing associated with validation or qualification. Will consult and work with SMEs from other departments.
  • Driving continuous improvement and a culture of Operational Excellence, ensuring Bacthera delivers on KPIs associated with Right First Time and On Time Delivery.

Commercial support

  • Represents Operations when assessing new customer programs or requests, with respect to validation and qualification expertise.
  • Provides the input to Business Development and Project Management when scoping new customer projects within the areas of validation and qualification supporting Operations in performing the ‘initial’ facility fit evaluation as part of prospect review.

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, Head of Human Resources; saga@bacthera.com.

We are looking forward to welcoming you in our new production site in the Stücki Business Center in Basel.