Associate Director-QC Micro Product and Raw Materials

Job Description

Job Description

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.

Position Brand Description:

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.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Management and Leadership responsibilities such as:

a. Direct all group activities of up to 30 QC staff which may include management levels.

b. Prioritize laboratory workload, re-prioritize as needed and ensure completion of all tasks.

c. Promote a culture that pursues integrity, operational excellence, and respect for people.

d. Identify analytical projects required to achieve group and corporate objectives. Plan and coordinate implementation of desired outcome(s). Strategize against corporate objectives.

e. Work independently but ensure communication of critical information upward with buy-in from senior management for key decision-making.

f. Evaluate, coach, and manage personnel performance. Set group objectives with management.

g. Participate in the budget process, including professional services. Monitor group spending to remain on track with budget.

h. 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.

i. Build a strong, responsive team that is reliable, responsive, and flexible to shifting demands.

j. Focus on the situation and/or problem not the person. Maintain the self-esteem of staff.

2. Technical responsibilities such as:

a. Represent the department as a technical expert on the methods performed in the group and the results reported.

b. Conduct thorough document reviews, including submissions to global health authorities.

c. Respond effectively to any product or method-related trends.

d. Use scientific expertise to assist direct reports with troubleshooting, investigations, and problem resolution, including contract testing. Implement process improvements with senior leadership.

e. Apply strategic-thinking and forward planning with high level of ownership/accountability.

f. Ensure that all lab operations and documentation meet all quality and regulatory requirements.

g. Provide oversight and drive the reduction of analytical investigations and deviations while striving for operational excellence.

3. Compliance responsibilities such as:

a. Assure adherence of acceptable cGMP practices by staff during execution of all work tasks.

b. Review departmental documentation for conformance with global corporate policies and regulatory guidance.

c. Represent the company through effective interactions with all regulatory officials, as needed, related to QC expertise.

Manage Relationships with Key Stakeholders and Customers:

1. Interacts with local and global functional areas and external suppliers/agencies. Influences, negotiates, and makes decisions through those interactions.

2. Drives cross functional alignment and integration with Process Team.

3. Liaison between the Process Team and other site functional leaders.

Staff Development and Management:

1. Responsible for developing employees and future leaders.

2. Coach and mentor for internal resources.

Resource Management:

1. Fosters an inclusive workplace and engaged workforce.

2. Ensures effective hiring and staffing (right person for the right role).

Basic Requirements:

1. Supervisory position with previous management experience.

2. Proven competence with related technical experience. Experience in monoclonal antibody is not required but a definite asset.

3. Excellent working knowledge of cGMP regulations for QC laboratory applications is required.

4. Excellent teamwork and communication skills. Attentive to detail. Good computer skills.

5. Ability to take initiative, to be assertive, to lead by example and to build relationships.

6. Strategic thinking capabilities. Forward planner. High level of ownership/accountability.

7. Ability to effectively represent the company with FDA and other Regulatory Agency officials related to QC expertise.

Additional Preferences:

1. Supervisory position with 3-5 years of previous management experience.

2. Proven competence with 10+ years of related technical experience. Experience in monoclonal antibody is not required but a definite asset.

Education Requirements:

1. BS is required. Advanced scientific degree is preferred.

This role is exempt and the anticipated compensation for this role is $135,000 - $180,000.

This is a banded role, and candidates will be placed within the range based on experience, skills, internal equity, and market considerations.

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.