Head Upstream Process

Careers at Valerius Biopharma, committed to providing specialty biosimilar drugs globally
 
Are you looking to making a difference?
 
Valerius Biopharma AG is a biopharmaceutical company in Switzerland, established to provide affordable treatment options for high-priced biologics through development of specialty biosimilars. Our interdisciplinary team of professionals represents decades of experience gained in the biotechnology and biosimilar industry. Expertise in process science, a deep understanding of proteins and their underlying complexity, as well as skilled clinical and regulatory expertise, are key factors to our success.
We are committed to making treatment of severe and life-threatening diseases more accessible to all patients worldwide.
 
For our emerging development hub in the south-east of Belgium (Eupen/Liège) we are seeking highly skilled and motivated associates to join us in building a world leading center for specialty biosimilar drug development.

Activities and responsibilities

Primary objectives & goals

The Head Upstream Process (USP) is leading the USP team and designs, executes and interprets experiments to set up the development of cell lines and cell banks, the fermentations and all related processes, and manages the associated infrastructure including the according documentation (protocols, reports, SOPs), batch releases of raw material, material shipments, and laboratory equipment monitoring. 

Scope & Responsibility
  • Lead and manage the USP team.
  • Represent USP for the assigned portfolio at management and external stakeholder levels. 
  • Oversees all USP programs and projects, guides teams to ensure cross-functional integration, coordination and alignment. 
  • Ensures direct reports are actively and appropriately aligning with other teams to ensure timely and on-target results.
  • Provides leadership guidance and direction in ongoing enhancements/development of core and sub-team processes, structures, systems, tools and other resources.
Overall team’s responsibility
  • Support establishment of new platform technologies for high throughput upstream process development using mammalian cell cultures.
  • Design, plan, organize, execute and analyse experiments to develop and execute the transfer (scale up) of processes in to production facilities.
  • Supports the development of new experimental approaches and related work processes and procedures that align with company and regulatory requirements.
  • Conduct test runs.
  • Keep records in electronic laboratory notebooks, and authoring of procedures, protocols, technical reports, standard operating procedures (SOPs) and presentations.
  • Release batches, organize and oversee shipments to and from external stakeholders, support Clinical Study logistics.
  • Operate Upstream Process GMP production.

Qualification profile

Desired Professional and Technical Requirements

Education/Qualifications
  • Completed studies, preferably MSc or PhD, in Biotechnology, Biology, Chemistry, Engineering, or a comparable degree with corresponding professional experience.
Experience, Skills, Knowledge
  • At least 4-year experience in upstream process development and manufacturing techniques. 
  • Strong track record with mammalian cell cultures (e.g. CHO, SP2/0) and knowledge of cultivation techniques.
  • Experience with single-use bioreactors from mL-scale to 200 L production scale favourable
  • Leadership/management experiences.
  • Knowledge of biopharmaceutical active substance production and analytics. 
  • Good knowledge of English written and oral.

Send application to

Valerius Biopharma AG

Norbert Bleich
Stänzlergasse 4
CH-4051 Basel
Phone: +41 61 205391-334
application@valeriusbio.com
www.valeriusbio.com

While applying for the job please refer to jobvector and use the following reference number: TD101

About Valerius Biopharma AG

Careers at Valerius Biopharma, committed to providing specialty biosimilar drugs globally   Are you looking to making a difference?   Valerius Biopharma AG is a biopharmaceutical company in Switzerland, established to provide affordable treatment options for high-priced biologics through development of specialty biosimilars. Our interdisciplinary team of professionals represents...

More about Valerius Biopharma AG