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Analytical Development and Transfer Engineer

Kelly Scientific Genève — Suisse romande
29.03. | Temporary | 100%


Kelly Scientific is looking for its biotech partner localized in Switzerland an Analytical Development and Transfer Engineer (6 months mission - could be extended)

 MISSIONS 
 

  • You...

Analytical Development and Transfer Engineer


Kelly Scientific is looking for its biotech partner localized in Switzerland an Analytical Development and Transfer Engineer (6 months mission - could be extended)

 MISSIONS 
 

  • You will be responsible for method transfers, method improvement, remediation, method validation/verification and/or troubleshooting of commercial products (API and drug product) within the QC laboratory.
  • You will serve as a Subject Matter Expert
  • You will be responsible for investigating commercial product complaints at all manufacturing sites, domestic, international and CRO.
RESPONSABILITIES

Perform Validation of Analytical Methods or Tech transfer:
  • Responsible for monitoring and managing the life cycle of assigned analytical methods.
  • Design and perform experiments to evaluate analytical methods associated with commercial products for feasibility, method improvement, remediation and/or troubleshooting.
  • Write formal analytical documents such as validation protocols, method transfer protocols and investigations reports.
  • Conduct analytical method transfer to internal and/or external commercial manufacturing/testing facilities.
  • Support laboratory investigations, deviations, CAPA's, Change Controls
  • Ability to troubleshoot method and/or equipment issues to the root cause
  • Capable of resolving non-routine laboratory issues and problems expeditiously
  • Interact with CSPs, reviews raw data generated by CSPs and supports their lab investigations as needed
  • Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS)
  • Participate in audits and interacts and answers questions from Heath Authorities
Oversight of external Analytical Service Providers:
  • Support the approval and qualification process
  • Review raw data (QC peer review)
  • Participate in the inspection/audit at Contract Service Providers
  • Provide support to Service Providers during Health Authority inspections
Performs general administrative and organizational activities:
  • Subject Matter expert for internal/external audits
  • Develop strategies for method transfer and implementation for new products and excipients
  • Perform QC oversight of commercial CSP's
  • Acts as functional area expert
PROFILE
 
  • Master or Technical Bachelor Degree in Biotechnology, Biology, Biochemistry
  • Experience with small molecules and/or biologics in oral dosage and/or sterile injectables
  • Good knowledge of cGMP
  • Understanding of analytical validation and technical transfer concepts and requirements
  • Ability to interface with Regulatory Authorities and Contract Service Providers
  • Knowledge of international regulatory requirements, ICH, and Good Automated Manufacturing Practice (GAMP) 
  • Advanced knowledge of laboratory and aseptic processes
  • Advanced knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio
APPLICATION

Thans to apply online

Your contact at Kelly: 
Mrs Karine Legerot
Consultant Professional Staffing Life Science
Kelly Scientific Geneva

ABOUT KELLY

Kelly Services® is a global leader in providing staff solutions and active in more than 40 countries.
Together with its subsidiaries, Kelly offers a wide variety of outsourcing and consulting services as well as staff services,
from permanent and management positions to temporary positions.
For over 70 years, we have worked with passion and commitment to connect talents with companies.
With more than 200 employees in over 40 branches and specialist departments,
Kelly Services (Switzerland) AG has been active in Switzerland since 1979.

www.kellyservices.ch
 

29.03.2020
Employee, 100%

Contact

Kelly Scientific Genève

Karine Legerot

Rue du Rhône 114

1204 Genève

Phone: +41 22 737 12 00

Fax: +41227371213


Kelly Scientific Resources

rue du Rhône 114Geneve

Industry

Human resources / Personnel services
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