Founded in 1997 and headquartered in Basel, Switzerland, CTC is a specialist life-sciences recruitment organisation. We place specialist talent into contract and permanent positions in the pharmaceutical, biotech, medical devices and CRO industries.

An in-depth experience in life-sciences recruitment combined with an established and extensive local network means that CTC offers clients and candidates the “Gold standard” in recruitment services. With an expertise honed over many years at the cutting-edge of the life-sciences industry, we help companies find people and we help people find companies.

 

Process Validation Scientist/Engineer for Biologics DP– 6194 ASH

 

Our client, a dynamic global bio-pharmaceutical company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a  Process Validation Scientist/Engineer for Biologics DP  on a 12 months contract ( yearly Extendable)  based in the Schaffhaussen area in Switzeraland.

 

This person will provide the technical insight and support the DP leads to effectively deliver qualification of equipment, aseptic process simulation, processing/hold times, and manufacturing processes in line with the supply chain network strategy and in compliance with the regulatory framework. This role will partner with the Analytical, Process, Quality, and Regulatory technical leads to ensure DP manufacturing equipment and processes are flawlessly introduced into the supply chain network and ongoing production consistently satisfies quality and regulatory requirements.

 

 

Main Responsibilities:

 

  • Support complex technology transfers with a focus on right-first-time execution and risk management.
  • Author, review, and approval of technical and regulatory documents (e.g., SOPs, work instructions, batch records, validation protocols, control strategy, and reports).
  • Support DP Process Performance Qualification and preparation of regulatory reports.
  • Support the internal and external teams in qualification of DP manufacturing equipment.
  • Perform as SME to identify technical areas for improvement, and supply chain improvement.
  • As needed, provide SME input on change management, product impact assessment and implementation of changes to the DP manufacturing processes.

 

 

Qualifications and Experience:

 

· Relevant working/residency permit or Swiss/EU-Citizenship required.

·        Engineer or Scientist, MSc or equivalent in a technical field (Chemistry, Pharmaceutics, Biological Sciences, Chemical Engineering) with +4 years of experience in biopharmaceuticals or bachelor’s degree with + 8

years of experience

·        Expertise in late-stage biologic DP manufacturing equipment and processes. Hands-on experience in other areas such as Quality, R&D and Manufacturing Operation is highly desirable

·        Proven track record in atleast 3 of the mentioned areas: DP comparability, Equipment qualification , Pharmaceutical process development, Technology transfer, Process validation

·        Demonstrated technical competency and experience with biologic DPs.

·        Demonstrated experience in technology transfers projects.

·        Partnering with R&D and commercial supply to improve the fit for plant and commercialization of new products into the supply chain.

·        Demonstrated leadership in providing integration of activities, information across multifunctional groups and sites.

·        Planning and logistics skills capable of effective integration of deliverables at the manufacturing site level.

·        Ability to foster team productivity and cohesiveness and to work collaboratively to execute, deliver and get results through the various matrix teams.

·        Ability to influence and lead peers, superiors, and external partners, including interaction with senior management.

·        Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly.

·        Ability to manage complexity and change.

·        Collaborate and influence other functions/levels outside of own group and effectively leads cross functional and cross organizational teams to generally attain expected results for all parties.

·        Travel to the manufacturer(s) as needed to provide on-site support or oversight, especially during qualification of equipment

 

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.