WuXi Biologics · 12 hours ago
QC Senior Scientist I, Project
Cranbury, NJ
Full-time
Onsite
Senior Level
$73K/yr - $116K/yr
5+ years expWuXi Biologics is a leading global open-access biologics technology platform offering end-to-end solutions for biologics development and manufacturing. The QC Senior Scientist I will support Quality Control clients on various projects, ensuring compliance with industry standards and managing project deliverables effectively.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Supports in overseeing the Quality Control clients related integrated, standalone or related QC department projects
Lead multiple matrix teams involving Analytical development, QC testing teams to establish and accomplish method transfer and Qualification Strategy
Attends regular internal or external QC projects clients’ meetings to understand each clients’ specific requirements and needs
Able to work and collaborate closely with external departments such as PM and CMC leaders and communicate certain needs to QC internal testing functions to ensure smooth orderly management of QC methods and timelines
Provides key input and recommendation of clients’ data review or investigation process. Serves as lead for client discussions regarding project quality or investigations/deviations
Strong Technical and Scientific knowledge of protein-based assays, including HPLC, CE electrophoresis, ELISA, PCR and/or potency methods
Ensure compliance to training, testing, documentation and general lab management requirements for Industry Standards and/or Regulations
Participate in preparation of project-related audits when needed
Effective multi-tasking skills and time management required
Ability to evaluate technical data and record data accurately and legibly
Able to conduct or support clients’ site visits routinely or ad hoc basis
Supervises staff and manages staff’s deliverables to meet expectations
Ability to work effectively as part of a team and exhibit effective interpersonal skills
Support any required QC documentations such SOP, protocols, final reports, investigations, and deviations when needed
Conducts critical review of results and reports data when needed
Supports in proposal drafting, providing pricing support
Qualification
Required
Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field
At least 5+ years of relevant experience or equivalent for Bachelors', 3+ years for Master's in the Quality Control or related field or equivalent experience
Candidate must possess extensive knowledge and experience in analytical and QC operations of pharmaceutical industry, understand 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
Solid track record of working experience in quality control operation to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing
He or She should have demonstrated ability of problem solving and decision making
Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives
Preferred
Project management experience is preferred
Company
WuXi Biologics
WuXi Biologics is a open-access technology platform company offering end-to-end solutions to empower organizations to discover and develop.
10001+ employees
H1B Sponsorship
WuXi Biologics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (32)
2023 (22)
2022 (12)
2021 (17)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
unknown2017-06-13IPO
2017-01-01Series Unknown
Leadership Team
Jijie Gu, Ph.D.
Executive Vice President & Chief Scientific Officer & Global Head BD&L
Adrienne Johnson, SPHR
Sr. Human Resources Business Partner
Recent News
South China Morning Post
2026-01-23
South China Morning Post
2026-01-19
Company data provided by crunchbase