Associate - QA Manufacturing Operations Wed-Sat: 2pm-12:30am

Job Description

Job Description

Wednesday to Saturday 2nd shift: 2pm-12:30am

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 Quality Assurance Manufacturing Associate independently works within the Celltrion Branchburg Process Team environment to ensure Quality Systems and GMP compliance. This position aids and provides guidance to Process Teams in deviation investigations, change control assessments, procedure and master production record revisions, validations and MES exceptions /batch record review. Also, this role provides QA presence in Manufacturing areas by conducting periodic walkthroughs and aids, where necessary, during regulatory/partner inspections.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning

1. Support and provide guidance to Downstream Process Team(s) and other customers.

2. Evaluate deviations are raised where required and ensure appropriate root cause/likely assignable cause(s) and assess quality impact. Recommend CAPAs and ensure CAPAs implemented are effective.

3. Write/escalate Notifications to Management, as applicable.

4. Perform periodic walk-throughs and support area changeovers of Manufacturing facilities.

5. Perform Data Integrity Analysis and Audit Trail Reviews.

6. Perform MES exceptions /batch record review.

7. Perform training within group or throughout organization as needed.

8. Attend and serve as a key resource in ad-hoc meetings to provide compliance guidance to Manufacturing issues.

9. Support lot release through ensuring timeliness resolve of compliance issues, as applicable.

10. Assist in activities associated with technology transfers to and from Celltrion Branchburg facilities, as applicable.

11. Review and approve respective development and validation documentation.

12. Identify where change controls are required, evaluate change controls and associated risk assessments.

13. Support applicable on-time performance metrics.

14. Support audits performed by partners, Celltrion corporate, and/or regulatory agencies, as applicable.

15. Ensure compliance with applicable regulatory guidelines and GxP computer systems to global electronic records/signatures regulations (21 CFR Part 11, Annex 11, etc. as applicable).

16. Support floor time program and resolution of issues identified.

QA MFG (2nd Shift):

1. Escalate critical quality issues to management.

2. Coordinate with second shift Process Team representatives to resolve issues in real time and ensure

compliance to procedural requirements and proper documentation.

Basic Requirements:

1. Must possess working knowledge of domestic and international GMP regulations and other policies/regulations as applicable.

2. Must have the ability to function in a fast-paced environment and communicate effectively with management.

3. Must be able to work in a cross-functional team environment.

4. Must have demonstrate ability to work independently.

5. Must be proficient in Microsoft applications.

6. Previous technical or QA experience in biotechnology manufacturing processes and/or computer systems (large scale cell culture, purification processes, validation) is preferred.

Additional Preferences:

1. Strong understanding of data integrity principles and resolution of data integrity lapses.

2. Prior experience with quality management systems (deviation, change control, CAPA, activity planning) preferred.

3. Strong technical understanding of biotechnology processes preferred.

Education Requirements:

1. BA/BS degree in the hard sciences with a minimum of 1-3 years experience in the Biopharmaceutical industry. Preference for Chemistry, Biology, Biotechnology, Microbiology, Biochemistry, and Chemical/Biological Engineering.

This role is exempt and the anticipated compensation for this role is $71, 250 - $118,750.

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.

Wednesday to Saturday 2nd shift: 2pm-12:30am