Sr. Scientist - QC Microbiology

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 Senior Scientist – QC (Responsible Scientist) performs holistic data reviews, interprets results, and releases data for the QC Laboratories. The Responsible Scientist utilizes their experience and technical skills to assist laboratory analysts with problem-solving and to lead critical investigations, which may include control limits or specification excursions (OOS) and Out of Trend (OOT) results. The Responsible Scientist performs periodic evaluations of method performance, pharmacopeia reviews, and assesses/approves the impact of proposed method changes or modifications. They may also lead commercialization and technical agenda projects such as method validations, qualifications, method transfers, and equipment evaluation and qualification. The position is responsible for working collaboratively with lab staff and advising on best technical and compliance practices within the working group and across network laboratories.

Key Objectives/Deliverables:

Manage for Results /Strategic Planning:

1. Performs in-depth second-tier holistic review, including data integrity and technical assessment of all analytical testing associated with the batch, stability, reference standard characterization, and production testing support prior to the release of individual test data and issuance of CoT.

2. Performs periodic review of method performance within the QC Laboratories, including practice matches procedure and simplification support.

3. Trained as Qualified Lead Investigator supports QC on minor and moderate investigations.

4. Authors, reviews and approves technical protocols, reports, and risk assessments. May support Annual Product Review, Annual Report, and YBPR.

5. Supports analytical monitoring, compliance, and campaign readiness for specific products.

6. Interacts effectively with business partners to communicate and resolve QC Compliance related issues. Understands the business requirements of the other functions. Participates as a core member of QC process teams.

7. May own responsibility for the management of site reference standards and assay controls program.

8. Performs routine data trending review and shares across relevant teams within and outside of the department.

9. Technical reviewer of Analytical Investigations and advises on test plans.

10. Works with Regulatory Affairs to provide information and data supporting regulatory submissions.

11. Supports and participates in regulatory inspections and commitments.

12. Participates in method transfer activities, including advising on validation strategies and technical review of reports.

13. Evaluates and recommends new technologies for the QC Laboratories.

14. Support equipment evaluation and qualification studies.

15. Performs routine safety walkthroughs in the QC area.

Manage Relationships with Key Stakeholders and Customers:

Manufacturing, Quality Assurance, Technical Services, Regulatory Affairs

Basic Requirements:

1. Strong problem-solving skills with experience in Root Cause Analysis

2. Skilled in authoring technical documents.

3. Demonstrated proficiency in complex laboratory analysis, including, but not limited to bioassays, chromatographic, spectroscopic, and/or microbial assays

4. Strong quality and safety mindset

5. Understanding of compliance requirements and regulatory expectations

6. Strong oral and written communication skills

Additional Preferences:

1. Experience with a broad range of analytical techniques applicable to monoclonal antibodies

2. Knowledge of ICH guidelines applicable to biotech drug substance

3. Knowledge/experience in regulatory submissions and analytical method validation

4. Strong statistical skills

5. Strong technical writing skills

Education Requirements:

Bachelor's/Master’s in Chemistry, Biochemistry, Biology, Microbiology or equivalent experience.

Demonstrated relevant experience (3-5 years) in a GMP (analytical or microbiology) environment

This role is exempt and the anticipated compensation for this role is $87,000 - $147,000.

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.