Team Lead, 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 Team Lead will lead a team in the Cell-Based bioassay department. They will oversee resource allocation (personnel, equipment, space, operating resources). The Team lead will perform operational management in consultation with the department director. The employee is responsible for the implementation of Quality Management and HSE-requirements in their area. The team lead is the Subject Matter Expert (SME) for their CBBA team supporting CBBA and Enzyme Linked Immunosorbent Assays (ELISA) and other related technologies. This position is a team member in the Large Molecule & Advance Therapy Medicinal Products Services in a Good Manufacturing Practices (GMP) laboratory environment.

• Supervises and act as SME for CBBA. Troubleshoot assays as needed.
• Oversees training, development, and coordination of daily laboratory tasks for the team.
• Has experience with the following platforms:
• ELISA
• MSD-ECL
• Luminescent or Fluorescent Reporters (Plate Readers)
• Flow Cytometry
• Ensures on-time testing and delivery of analytical results to clients.
• Communicates effectively with clients and provides scientific expertise to projects.
• Has operational leadership of the team.
• Ensures adherence to HSE.
• Participates in forecasting and budgeting discussions.
• Responsible for personnel management and development.
• Seeks out continuous improvement opportunities and resource efficiency.
• Provides LIMS support and guidance as needed.
• Provides guidance for routine and feasibility studies, method developments, improvements of methods, quality control tasks as well as validations and verifications of methods together with the team for Solvias.
• Supports CBBA staff as well as project managers in technical, methodological, organizational, and financial aspects of requests for quotations, quotation preparation, acquisition and customer support.
• Follows GMP protocols and procedures as applicable.
• Ensures Laboratory maintenance.
• Participates in longer-term planning of equipment resources.
• Ensures compliance with GMP regulatory requirements and SOPs.
• Investigates under GMP for deviation, non-conformity, OOS, change controls and other quality events.
• Trains scientists and analysts in the team as needed.
• Contributes to process improvements for effective and efficient workflows in the lab.

Requirements

• M.S. or Ph.D. Life Sciences with 3+ years relevant experience or B.A/B.S. with 8+ years relevant experience.
• Prior supervisory 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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