Sr. Scientist - QC Microbiology

Celltrion Branchburg, LLC•Branchburg Township, NJ

2d•$87,000 - $147,000•Hybrid

About The Position

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.

Requirements

Strong problem-solving skills with experience in Root Cause Analysis
Skilled in authoring technical documents.
Demonstrated proficiency in complex laboratory analysis, including, but not limited to bioassays, chromatographic, spectroscopic, and/or microbial assays
Strong quality and safety mindset
Understanding of compliance requirements and regulatory expectations
Strong oral and written communication skills
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

Nice To Haves

Experience with a broad range of analytical techniques applicable to monoclonal antibodies
Knowledge of ICH guidelines applicable to biotech drug substance
Knowledge/experience in regulatory submissions and analytical method validation
Strong statistical skills
Strong technical writing skills

Responsibilities

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.
Performs periodic review of method performance within the QC Laboratories, including practice matches procedure and simplification support.
Trained as Qualified Lead Investigator supports QC on minor and moderate investigations.
Authors, reviews and approves technical protocols, reports, and risk assessments. May support Annual Product Review, Annual Report, and YBPR.
Supports analytical monitoring, compliance, and campaign readiness for specific products.
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.
May own responsibility for the management of site reference standards and assay controls program.
Performs routine data trending review and shares across relevant teams within and outside of the department.
Technical reviewer of Analytical Investigations and advises on test plans.
Works with Regulatory Affairs to provide information and data supporting regulatory submissions.
Supports and participates in regulatory inspections and commitments.
Participates in method transfer activities, including advising on validation strategies and technical review of reports.
Evaluates and recommends new technologies for the QC Laboratories.
Support equipment evaluation and qualification studies.
Performs routine safety walkthroughs in the QC area.