Analytical Op&QC Lab Scientist
vor 1 Monat
Natascia Sciamanna
Estelle Kotelon
HC-GM-DDBIB Analytical Op QC Lab2 BDC
Corsier-sur-Vevey | Route de Fenil Z.I.B.
An exciting new opportunity has risen at our State-Of-The-Art Biotech Development Facility in Switzerland.
Your role:
Reporting to the “Analytical Operations & Quality Control Lab Manager” in the Global Analytical Development organization, Senior Scientist role represents an opportunity to work in a team of highly empowered employees and significantly contribute to the startup of high-tech GMP analytical laboratories. Once functional, this role will give you direct responsibilities in ensuring method qualification and tech transfer activities are compliant to regulatory, contributing to their continuous improvement, supporting investigations and reporting, to ensure the delivery of our specialty innovator Biotech pipeline to patients. This position will also be responsible for coordinating CMC projects for QC relevant topics and supporting the team with scientific expertise in troubleshooting physico-chemical including MS and/or bioanalytical methods.
Your key responsibilities in this role are:
- Act as a subject matter expert for analytical method validation, verification and tech transfer activities of traditional and advanced analytical techniques, including but not limited to: HPLC, electrophoresis, UV-Vis Spectroscopy, ELISA based methods, digital PCR, Microbiology related methods, Mass Spectrometry based techniques including data analysis.
- Knowledgeable on ADC CMC development with focus on analytics and robotics automation.
- Provide technical leadership and project management for CMC projects on behalf of QC team.
- Draft technical documents for the QC unit, including validation protocols and reports, risk assessments, and analytical test procedures.
- Interpret complex data and solve scientifically challenging problems by providing direction and leadership.
- Support the investigations of method performance and reliability, and proposes improvements as needed.
- Directly interact with our business partners on a regular basis, including analytical development, process and quality stakeholders and testing laboratories in the network.
- Manage, investigate and close events and deviations, non-conformities, investigations, change controls and CAPAs.
- Support preparation of audits and interact directly with internal HCQ auditors and external regulatory agencies.
Who you are:
- Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology. PhD is a plus.
- 7+ solid hands-on experience in method development/validation/verification and tech transfer activities within the scope of physico-chemical, electrophoretic bioanalytical (microbiological methods is a plus).
- Extensive knowledge in DoE, data analysis and statistical evaluation of qualification data sets.
- Knowledge of ADC CMC development.
- Knowledge of analytical robotic platforms in QC context is considered as a significant plus.
- Thorough understanding and practical application of cGMPs and regulatory requirements (Swiss, FDA, EU, etc.).
- Excellent investigational skills and problem-solving skills. Ability to interpret complex situations and to articulate recommendations for resolution.
- Previous direct experience in audits and interactions with healthcare authorities.
- English fluent, French is an asset.
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