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Sr. Manager - Quality Control jobs in United States
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Celltrion Inc · 19 hours ago

Sr. Manager - Quality Control

Celltrion Inc is a company focused on quality control in the pharmaceutical industry, and they are seeking a Sr. Manager - Quality Control to lead the analytical staff and manage the day-to-day activities of the laboratory group. The role involves ensuring compliance with cGMP regulations, managing personnel performance, and serving as a technical resource for QC operations.
HealthcarePharmaceuticalHealth Care

Responsibilities

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

Qualification

CGMP regulationsSupervisory experienceTechnical expertiseBiologyBiochemistryComputer skillsTeamworkCommunication skillsAttention to detailInitiativeRelationship building

Required

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
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

Preferred

Experience in monoclonal antibody is not required but a definite asset

Benefits

Paid time off (holidays, vacation, and additional leave)
Medical, dental, and vision insurance
Life insurance
A company-matched retirement savings plan
Wellness programs
Short- and long-term disability benefits

Company

Celltrion Inc

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Celltrion is a fully integrated biopharmaceutical company dedicated to delivering innovative and affordable medications to improve patients’ access to advanced therapies.