Manufacturing Technical Writer

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 Manufacturing Technical Writer supports the Manufacturing Process team (s) in authoring, reviewing, and approving of GMP documentation, i.e. Process Batch Records, Standard Operating Procedures (including procedures that support the execution of Electronic Batch Records) and Forms, to support the manufacture of commercial and clinical products in the BB50 Manufacturing Facility. This position plays a key role in the success of product re-introductions as well as new product introductions. This position will routinely interact

with Operators, Process Engineering, TS/MS, Quality Assurance, Quality Control and Logistics departments. Working knowledge of cGMPs, manufacturing operations and documentation support systems, such as Regulus and Trackwise is essential.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Responsible for ensuring production documentation, such as Process Batch Records, Standard Operating Procedures (including procedures that support the execution of Electronic Batch Records) and Forms, are accurate as compared to relevant Technology Transfer Documents and available for use, i.e. authored, reviewed, approved, and released, in a timely manner to support manufacturing operations.

Facilitate PmatchesP exercise as needed.

2. Ownership of the Manufacturing Document Revision Tracking Spreadsheet(s) and responsible for ensuring modifications to batch records that apply to multiple products are integrated into each applicable production process as each product is introduced/re-introduced into the facility.

3. Provide visibility of documentation review/approval schedule to Process Team and drive Process Team to meet documentation review/approval timelines.

4. Support continuous improvement efforts both from a quality and efficiency perspective by streamlining batch records and standard operating procedures as well as review and approval process.

5. Responsible for owning document related change control implementation summaries for manufacturing department as required.

6. Author, review and approve technical reports as required.

7. Subject matter expertise and execution of routing and managing documents in the controlled quality documentation system.

8. Contribute and adhere to safety, environmental, quality standards of the Corporation.

9. Provide guidance on the document revision process for the local Document Management System.

Basic Requirements:

1. Must have a technical proficiency of operations within an area and be willing to acquire technical proficiency of operations within all areas of manufacturing.

2. Must be able to write effectively as demonstrated through authorship of batch records, standard operating procedures, and observations / deviations.

3. Must exhibit a team first attitude.

4. Must possess excellent organizational, communication, interpersonal, and written skills.

5. Must be able to prioritize work, drive projects to completion and collaborate with cross functional groups to drive decisions to support documentation completion.

6. Must meet the physical requirements of the job; must have the ability to:

a. Wear appropriate clean room attire.

b. Walk down systems when writing documents to ensure completeness.

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 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.