Associate - Technical Quality Assurance

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:

This role will provide guidance and direction for day-to-day quality activities ensuring GMP compliance supporting the operations at Celltrion Branchburg. This role primarily provides quality oversight of site qualification and validation programs (equipment, cleaning, steaming, etc.), resolves key technical/quality problems and drives solutions that impact the site. This role will lead small/medium-scale projects or programs with small/moderate risk and/or complexity. This role will aid cross-functional groups and/or management with troubleshooting investigations and problem resolution. This position will assist in the implementation of quality improvement plans. This role provides QA presence in areas of responsibility (manufacturing, laboratories, FUME, etc.) by conducting periodic walkthroughs. Additionally, this role will ensure regulatory compliance and procedural consistency between manufacturing facilities and prepare cross-functional partners for Regulatory Inspections. Provides assistance, where necessary, during regulatory/partner inspections and ensures compliance observations associated with Celltrion Branchburg Manufacturing Facilities are adequately addressed and completed on schedule.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

Technical and Compliance Oversight:

• Provide quality oversight of site qualification and validation programs (equipment, cleaning, steaming, etc.)to ensure deliverables are achieved in compliance, and assets are maintained in a qualified/validated state.
• Review/approve standard operating procedures, specifications, validation documentation, instrument acquisitions/decommissions, job plans, work orders, as applicable. Ensure processes are harmonized across multiple business areas.
• Support floor operations: review/approve procedures.
• Participate in and/or lead self-inspection activities.
• Monitor the qualified utilities and equipment performance to ensure compliance with Quality (internal/external) requirements/regulations.
• Represents Quality in meetings as required.
• Know the Operational Control Strategy and potential failure modes of the operation.
• Know the historical deviations/gaps, trends and audit history of the process, equipment, utilities, and maintenance.
• Perform classification, review and approval of changes.
• Use statistical data to understand the sources of variability and to continuously improve.
• Serve as a liaison between supported area and other Quality areas (Labs, Incoming, etc.).
• Assess, review and approve deviations, assuring robustness of Root Cause Analysis and effectiveness of CAPA’s.
• Understand the science behind the process and equipment to facilitate science-based decision making.
• Always comply Site Safety Requirements.

Quality Systems and Business Processes Improvement

• Knowledgeable of the various areas within the QA unit (e.g. Process, Compliance, Computer Systems Qualification, Engineering…)
• Participates/represents Technical QA in plant-wide projects/initiatives, as requested.
• Uses productivity tools to drive improvements (e.g. Six Sigma)
• Understands status and defines/leads initiatives to optimize Quality Systems and Business Processes on site.

People Development

• Provides coaching and guidance to supported area personnel.
• Coaches Quality Representatives on Quality expertise as related to utilities, equipment, maintenance, and facilities.
• Educates the Operation and support groups on internal and external regulations.

Manage Relationships with Key Stakeholders and Customers:

• Directly support Site Process Teams and communication with Site Flow Teams

Basic Requirements:

• Establish positive interpersonal relationships and interact effectively with people.
• Strong communication skills and the ability to collaborate with other parts of the organization and across multiple levels.
• Work variable periods of time (short and long).
• Memorize details, ideas, and instructions.
• Work with multiple assignments at a time and within an environment with distractions.
• Lead qualification activities.
• Work under time pressure.
• Have good judgment in special situations.
• Make decisions.
• Work under minimal supervision.
• Travel to the interior and exterior of the country.
• Work irregular hours, weekends and/or holidays as needed.
• Work as a resource in other functional areas as dictated by business strategies.

Education Requirements:

• Bachelor’s degree in engineering or science with a minimum of 1-3 years’ experience in the Biopharmaceutical industry or equivalent experience.
• Previous technical experience should be in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation).

This role is exempt and the anticipated compensation for this role is $71,250 - $116,000. 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 0-10% 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.