The Manager of Biologics oversees the operations and activities of the Biologics team, providing expert guidance in the development and execution of a broad range of methods for Biologics analysis. The role requires extensive knowledge and experience in analyzing primary, secondary, and tertiary protein structures using techniques like amino acid analysis (AAA), N-terminal sequencing, circular dichroism (CD), FTIR, DSC, and LCMS, as well as quaternary structure and aggregate analysis using SEC-MALS, svAUC, and DLS. The Manager will design and manage analytical plans to advance Biologics throughout various development stages and ensure smooth project execution, working closely with technical and project management teams. This is a client- and internal-facing position that requires a high level of multitasking, deadline management, and commitment to delivering quality results.

Responsibilities:

• Lead and oversee activities within the Biologics department, supervising team leads to ensure efficient test scheduling, preparedness, execution, and reporting.
• Act as a technical authority in Biologics, providing guidance and leadership to relevant teams.
• Establish and maintain systems to ensure exceptional client service in the Biologics department.
• Address client requests for Biologics information, quotes, or other services promptly and effectively.
• Devise, execute, and oversee all studies related to Biologics.
• Foster long-term client relationships built on scientific expertise, technical proficiency, and professional integrity.
• Oversee and manage both routine and specialized large molecule testing requested by clients.
• Ensure comprehensive understanding and adherence to all laboratory SOPs, as well as GMP/GLP and ISO requirements relevant to laboratory work.
• Provide scientific leadership in all technical areas, especially large molecule analytical development, stability and release testing, test method development and validation, and specification establishment.
• Participate in department or company-wide projects aimed at enhancing client services.
• Ensure that scientists in the Biological Services laboratory have all necessary resources to complete their studies successfully.
• Inform the Quality Assurance department of regulatory issues related to testing.
• Communicate with Project Coordinators regarding any special requests, sample log-in, reporting, or billing issues.
• Lead department or company initiatives to improve internal efficiency and overall work quality.
• Promote a collaborative and positive team environment within the lab.

Qualifications:

• Master’s degree in Biochemistry, Analytical Chemistry, Biology, or a related field is required.
• A minimum of 8 years of experience in advanced testing, analysis, and data interpretation within a regulated, commercial laboratory setting is required.
• At least 3 years of supervisory experience.
• Ph.D. in Biochemistry, Analytical Chemistry, Biology, or related field is preferred, or an equivalent combination of education and experience.