Sr. Manager - Quality Control

Overview

The QC Leader the day-to-day activities of up to 10 analytical staff and plans work for the group to respond to changing priorities. This role maintains a safe, orderly, and compliant work area according to company safety standards and cGMP regulations. Position requires 0-3 years of supervisory experience and 2-5 years of solid technical skills related to applied area. Assists with workload, as needed.

• Manage the day-to-day activities of the assigned laboratory group:
• Assign and monitor laboratory workload of routine and non-routine analyses by appropriate chemical, biochemical, and microbiological test methods. Performs assays as needed.
• Plan and organize analytical projects required to achieve group and corporate objectives.
• Evaluate, coach, and manage personnel performance. Set group objectives with mgt.
• Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
• Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
• Take initiative to make things better for the company, be aggressive with your work and assertive in your interactions, lead by example and build collaborative relationships.
• Be a technical resource for QC:
• Serve as a technical expert on the methods performed in the group and the results obtained.
• Use scientific expertise to provide assistance to coworkers for troubleshooting, laboratory investigations and problem resolution. Implement process improvements with management.
• Ensure QC Compliance:
• Assure adherence of acceptable cGMP practices by staff during execution of all work tasks.
• Compile and analyze data, prepare graphs, and write SOPs/reports. Conduct document reviews.
• Review test results for conformance with specifications and effective documents.
• Evaluate data to detect product or method-related trends. Write periodic trend summaries.

• BS or MS in a related science such as a Biology or Biochemistry is required.
• 0-3 (or equivalent) years of previous supervisory experience.
• Proven competence in area to be supervised with 2-5 years of technical experience in protein product. Experience in monoclonal antibody is not required but a definite asset.
• Excellent working knowledge of cGMP regulations for QC laboratory applications is required.
• Excellent teamwork and communication skills. Attentive to detail. Good computer skills.
• Ability to take initiative, to be assertive, to lead by example and to build relationships.

This role is exempt and the anticipated compensation for this role is $103,500 - $138,000.

Celltrion Branchburg, LLC offers a comprehensive benefits package that includes paid time off (holidays, vacation, and additional leave), medical, dental, and vision insurance, life insurance, a company-matched retirement savings plan, wellness programs, and short- and long-term disability benefits. This role requires up to 10% travel, on-call availability, and may involve shift work. Hybrid work flexibility may be available based on business needs;

relocation assistance is not provided.

Celltrion Branchburg, LLC is proud to be Equal Opportunity Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity or expression, national origin, protected veteran status, disability, or any other legally protected status.