Scientist/Associate Scientist, Cell-Based BioAssay (CBBA)

Job Description

Solvias is an internationally recognized provider of integrated solutions in contract analytical research, development, and manufacturing. The company offers a broad spectrum of services and solutions in the Pharmaceutical, Biotech, Medical Device, Cell & Gene Therapy (CGT), and Cosmetic industries. With headquarters near Basel, Switzerland about 800 highly qualified employees take pride in putting science at the heart of serving customers to bring safer and better products to market faster.

Located at our large molecule headquarters in Research Triangle Park (RTP), North Carolina, the Scientist/Associate Scientist position will be in the CBBA team supporting CBBA and Enzyme Linked Immunosorbent Assays (ELISA). This position is a team member in the Large Molecule & Advance Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

• Develop, validate, and transfer analytical methods for the analysis of drugs using CBBA And ELISA according to GMP requirements.
• Perform quality lab activities according to assigned schedule.
• Collaborate with the team lead and senior scientist to train, develop, and coordinate daily laboratory tasks for the team.
• Generate, interpret data, and troubleshoot assays as needed.
• Handle multiple projects at the same time and ensure on-time testing and delivery of analytical results to clients.
• Ensure compliance with GMP regulatory requirements and Standard Operating Procedures (SOPs).
• Prepare and review lab notebooks, protocols, and reports.
• Investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events.
• Train peers and analysts in the team as needed.
• Contribute to process improvements for effective and efficient workflows in the lab.
• Maintain inventory, ordering of laboratory supplies, and instrument maintenance.
• Work collaboratively with cross-functional teams and customers.

Requirements

• M.S. Life Sciences with 3+ years relevant experience or B.A/B.S. with 7+ years relevant experience.
• Experience working in GMP or GLP environment.
• Experience in method development, qualification, and validation of CBBA, ELISA, and other emerging technologies.
• Experience communicating with clients is a plus.

Reporting Structure

This job typically reports to:

• Team Lead, CBBA

Note: This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization. Estimated travel is up to 10% annually as applicable.

Disclaimer: Solvias North America does not currently offer relocation packages or sponsor work visas. All applicants must have the legal right to work in the location of the job posting.

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