About the Opportunity
We are seeking a highly skilled Senior Scientist to join our team at the State-Of-The-Art Biotech Development Facility in Switzerland. This role will play a critical part in the startup of high-tech GMP analytical laboratories and will be responsible for ensuring method qualification and tech transfer activities are compliant with regulatory requirements.
The Senior Scientist will work closely with the Analytical Operations & Quality Control Lab Manager in the Global Analytical Development organization to ensure the delivery of our specialty innovator Biotech pipeline to patients. This includes coordinating CMC projects for QC relevant topics, supporting investigations and reporting, and providing scientific expertise in troubleshooting physico-chemical including MS and/or bioanalytical methods.
Key Responsibilities
* 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, etc.
* Provide technical leadership and project management for CMC projects on behalf of the 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 propose improvements as needed.
* Directly interact with business partners, 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.
Requirements
* Graduate degree in Chemistry, Pharmacy, Biology, or Biotechnology.
* 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 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 articulate recommendations for resolution.