Associate Director-QC Micro Product and Raw Materials

About the role

Celltrion Branchburg, LLC, a subsidiary of Celltrion USA, is seeking a QC Leader to oversee a group of up to 20 analytical QC staff (including supervisory levels), plan work in response to changing priorities, and maintain a safe, orderly, and cGMP-compliant work area.

Responsibilities

• Management and Leadership
  • Direct all group activities of up to 30 QC staff, which may include management levels.
  • Prioritize and reprioritize laboratory workload to ensure task completion.
  • Promote a culture of integrity, operational excellence, and respect for people.
  • Identify analytical projects needed to meet group and corporate objectives; plan and coordinate implementation.
  • Work independently while communicating critical information upward and securing senior-management buy-in for key decisions.
  • Evaluate, coach, and manage personnel performance; set group objectives with management.
  • Participate in the budget process (including professional services) and monitor group spending to remain on track.
  • Take initiative to improve company outcomes; lead by example and build collaborative relationships.
  • Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.
  • Focus on situations/problems rather than individuals; maintain staff self-esteem.
• Technical responsibilities
  • Serve as the department’s technical expert on methods performed and results reported.
  • Conduct thorough document reviews, including submissions to global health authorities.
  • Respond effectively to 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 a high level of ownership and accountability.
  • Ensure all lab operations and documentation meet quality and regulatory requirements.
  • Provide oversight and drive reduction of analytical investigations and deviations while striving for operational excellence.
• Compliance responsibilities
  • Assure adherence to acceptable cGMP practices by staff during execution of all work tasks.
  • Review departmental documentation for conformance with global corporate policies and regulatory guidance.
  • Represent the company in interactions with regulatory officials as needed, relating to QC expertise.
• Stakeholder and customer management
  • Interact with local and global functional areas and external suppliers/agencies; influence, negotiate, and make decisions through those interactions.
  • Drive cross-functional alignment and integration with the Process Team.
  • Act as liaison between the Process Team and other site functional leaders.
• Staff development and management
  • Develop employees and future leaders; coach and mentor internal resources.
• Resource management
  • Foster an inclusive workplace and engaged workforce.
  • Ensure effective hiring and staffing (right person for the right role).

Requirements

• Supervisory position with 3–5 years of previous management experience.
• 5–7 years of solid technical experience related to chemical, biologics, and/or microbiological testing of raw materials, drug substance, and drug product for small and/or large molecules.
• BS required; advanced degree preferred.
• Excellent working knowledge of cGMP regulations for QC laboratory applications.
• Excellent teamwork and communication skills; attentive to detail; good computer skills.
• Ability to take initiative, be assertive, lead by example, and build relationships.
• Strategic thinking and forward-planning capabilities with a high level of ownership and accountability.
• Ability to effectively represent the company with FDA and other regulatory agency officials regarding QC expertise.

Benefits

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

Pay

The anticipated compensation range is $135,000 – $180,000, with placement within the band determined by experience, skills, internal equity, and market considerations.

Schedule

• This role may require 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.