Senior Analyst/Analyst, 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 Senior Analyst/Analyst position will be one of the primary lab analysts for the CBBA team supporting CBBA and Enzyme-Linked Immunosorbent Assays (ELISA). This position is a team member in the Large Molecule & Advanced Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

• Perform quality lab activities according to assigned schedule.
• Process samples for release and stability testing, including complex sample preparation, according to GMP requirements.
• Document experiments, sample tracking, and raw data according to Standard Operating Procedures (SOPs) and GMP requirements.
• Support development and validation of CBBA and ELISA.
• Generate, perform data analysis, and interpret data for assays as needed.
• Ability to execute protocols ensuring compliance with GMP regulatory requirements and SOPs.
• Demonstrate good pipetting skills and aseptic techniques in the lab.
• Collaborate with scientists and team lead to investigate under GMP for deviation, non-conformity, Out of Specifications (OOS), change controls, and other quality events.
• Train peers 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

• B.A/B.S. in Life Sciences with 2+ years relevant experience.
• Experience working in GMP or GLP environment is preferred.
• Experience in release testing, supporting method development, qualification, and validation of CBBA and ELISA is encouraged.

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.
• Experience with different cell cultures and plate-based assay.

Reporting Structure

This job typically reports to:

• Team Lead, CBBA

This job description is not intended to be all-inclusive. Individuals may perform other related duties to meet the ongoing needs of the organization.

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.

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.

Apply Now