Associate Director-QC Micro Product and Raw Materials

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Full Time Branchburg, NJ, US

3 days ago Requisition

Salary Range: $ To $ Annually

Celltrion is a leading biopharmaceutical company that specializes in research, development and manufacturing of innovative therapeutics. We are committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. We have been at the forefront of biotherapeutic development uncovering new ways of targeting the drivers of disease by creating next-generation biologics and small molecule products. Celltrion Branchburg, LLC is a subsidiary of Celltrion USA, established in 2025 following Celltrion USA’s acquisition of Eli Lilly’s drug substance (DS) manufacturing facility located in Branchburg.

By linking robust local manufacturing capabilities with an existing direct sales network, we aim to generate greater synergies across our operations. Looking ahead, we also anticipate expanding into the global contract manufacturing organization (CMO) sector.

The QC Leader all group activities of up to 20 analytical QC staff which may include supervisory levels. 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 3-5 years of supervisory experience and 5-7 years of solid technical experience related to Chemical, Biologics, and or Microbiological testing of raw materials, drug substance and drug product of small and or large molecules.

BS is required and an advanced degree is desirable. This role will effectively represent the company with FDA and other Regulatory Agency officials related to QC expertise, as needed.

• Management and Leadership responsibilities such as:
  • Direct all group activities of up to 30 QC staff which may include management levels.
  • Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.
  • Promote a culture that pursues integrity, operational excellence, and respect for people.
  • Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s). Strategize against corporate objectives.
  • Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.
  • Evaluate, coach, and manage personnel performance. Set group objectives with management.
  • Participate in the budget process, including professional services. Monitor group spending to remain on track with budget.
  • 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.
  • Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
  • Focus on the situation and/or problem not the person. Maintain the self-esteem of staff.
• Technical responsibilities such as:
  • Represent the department as a technical expert on the methods performed in the group and the results reported.
  • Conduct thorough document reviews, including submissions to global health authorities.
  • Respond effectively to any product or method-related trends.
  • Use scientific expertise to assist direct reports with troubleshooting, investigations, and problem resolution, including contract testing. Implement process improvements with senior leadership.
  • Apply strategic-thinking and forward planning with high level of ownership/accountability.
  • Ensure that…