Job Opportunity

Job Opportunity

QC Principal Scientist

QC Principal Scientist

United States Posted 2026-01-21

Job Title - QC Principal Scientist

Work Location - Cranbury NJ

WuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, Unity, and Determination. WuXi Biologics offers exciting job opportunities and careers around the globe. We currently employ over 12,000 people and provide services to more than 600 customers worldwide, including all the top 20 biopharmaceutical companies.

Job Responsibility

Lead, manage and support the QC compendia team in accordance with cGMP requirements.
Responsible for QC compendia daily operation and management to comply with GMP, results delivery, data reliability and occupational safety protection requirements. Ensure the team adhere to successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation towards project timelines.
Responsible for reviewing and assessing compendia AMP (project specific or platform) and protocol.
Responsible for drafting QC department documents, quality standards, analytical method SOPs and application materials, as well as review of relevant documents from other departments involving QC.
May participate in drafting department in LIR (lab investigation), or lab OOS, and reviewing changes and deviations in other departments involving QC.
Provide laboratory support guidance in any related investigation of production deviations and assist in solving quality problems that arise during technology transfer and daily production (when required).
Provide compendia or required analytical QC training (in terms of activities/discussions/workshop) for QC department staff and ensure adherence to timely GMP trainings.
Ensure team is properly following DI, GDP and GMP compliance policies and regulations in QC daily work.
Ensure that laboratory reagents, consumables and related test solutions are managed and stocked sufficiently (without impacting testing TAT) as required
Participate and involve in QC department project management as Functional Sponsors (FS) or Leaders (FL) as required. Assist, resolve or advise QC FL during the project progress on possible challenges or issues.
May draft relevant CMC sections for regulatory submissions including INDs and BLAs. This also includes the reviewing and approval of project related IPT, IPC and testing protocols.
Participate in Quality Control system improvement initiatives and support the integration of WBS (Wuxi Business System) concepts and mechanisms into the SG QC daily operations. Initiatives such as managing the GEMBA process, Tier 1 accountability board review, editing/approving QC SOPs, designing and advising systems functionality (LIMS, ELN, SAP etc.), assisting the internal QC compliance team.
May participate in clients’ audits, regulatory audits and internal and external inspections. Ensure department compliance metrics are well controlled to adhere to the QA Quality council and Quality Management review metrics.
Work with QC Head in budget planning directions in terms of CAPEX and OPEX expenditure for the department as part of company-wide cost control policy.
Other duties as assigned by superior

Qualifications

Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors
Bachelor's degree: at least 9-11years of experience in the professional field.
Master's degree: at least 7-9 years of experience in the professional field.
PhD: at least 2-4 years of experience in the professional field
Having knowledge, understanding and experience in analytical and QC operations of pharmaceutical industry, current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Author, review, and approve SOPs, validation protocols, investigations, specifications, and related documents. Closely work with staff members to initiate deviations, CAPA, OOS, and OOT investigations.
Effective multi-tasking and time management skills.
Ability to use judgment as dictated by complexity of situations
Ability to work in a team environment and independently as required

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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