Principal 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 RTP, North Carolina, the Principal Scientist will be the Subject Matter Expert (SME) for the Cell-Based bioassay department. They will oversee resource allocation (personnel, equipment, space, operating resources). Principal Scientists are scientifically renowned leaders in their representative field of work. They represent Solvias within their focused technology and field of work to the inside and outside world. Principal Scientists participate in continuous improvement processes around CBBA work, making sure that in-house developed methods and services are state of the art and of exceptional quality. Principal Scientists will attend conferences and perform talks, present posters, network, and support sales activities in road shows and customer interactions/visits. They may also actively publish scientific work performed at Solvias with the goal of increasing outside visibility of the services and quality available at Solvias. Additionally, Principal Scientists perform and/or lead other scientists to achieve excellent work results with high scientific complexity. They plan, manage, and support both Non-GMP and GMP analytical work.
The Principal Scientist ensures that the work is performed smoothly and according to scope. This position is a team member in the Large Molecule & Advance Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

• Continuously improves developed methods and services, pursuing innovation and optimization.
• Collaborates with the US Commercial team to strengthen Solvias’ brand recognition in North America.
• Represents Solvias within the CBBA team, both internally and externally.
• Oversees and supports highly complex CBBA analytical work, ensuring compliance with cGMP standards.
• Provides expertise in method development, service improvements, and automation. Leads innovation in new methodologies using cutting-edge technologies and scientific advancements.
• Develops automation and quality improvement solutions for analytical projects, addressing both internal and external customer needs.
• Prepares scientific documents, presenting results and expert recommendations to clients.
• Engages with project teams and scientific experts to foster collaboration and knowledge exchange.
• Serves as the CBBA Subject Matter Expert (SME).
• Maintains technical and scientific expertise required for role effectiveness.
• Leads the development of new methods and services, actively driving innovation.
• Applies technical expertise to support customer acquisition and retention efforts.
• Ensures compliance with GMP regulations, SOPs, and quality standards.
• Investigates deviations, non-conformities, OOS results, change controls, and other quality events under GMP.
• Trains and mentors scientists, analysts, and new employees.
• Enhances lab workflows through process improvements and automation.
• Collaborates with Team Leads, cross-functional teams, and customers.
• Provides scientific guidance for method development and optimization.
• Identifies and applies cutting-edge scientific advancements.
• Aligns activities with the CBBA Director and supports sales efforts to increase visibility.
• Adheres to Solvias’ Quality Management System and HSE requirements.
• Applies automation and operational excellence principles to ensure high-quality results.
• Reports potential bottlenecks, barriers, or complaints to the CBBA Director.
• Maintains industry knowledge and technical expertise for continuous improvement.
• Consults with the CBBA Director and project teams on method and service development.
• Ensures compliance with task specifications and instructions.
• Provides technical insights for customer quotations.

Requirements

• M.S. or Ph.D. Life Sciences with 7+ years relevant experience or B.A/B.S. with 15+ years relevant experience.
• Experience working in GMP or GLP environment.
• Strong experience in method development, qualification, and validation of CBBA, ELISA, and other emerging technologies.
• Client management experience in a CRO/CDMO is preferred.

Other Desired Skills/Abilities

• Excellent organizational skills, ability to work independently and collaboratively in a team environment.
• Strong written and verbal communication skills.

Reporting Structure

This job typically reports to:

• Director, 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.

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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