WuXi Biologics · 6 hours ago
Scientist II, Quality Control
Cranbury, NJ
Full-time
Onsite
Mid, Senior Level
2+ years expWuXi Biologics is a leading company in the biotechnology sector, and they are seeking a Scientist II for their Quality Control department. This role involves ensuring the quality and timely delivery of test results and validation data, while also serving as a Subject Matter Expert in various QC disciplines.
BiotechnologyHealth CareManufacturingPharmaceutical
Responsibilities
Ensure successful method transfer, including training of personnel for execution and review, review of data, and completion of documentation
Conduct assays and lab procedures according to and in compliance with cGMP guidelines and internal SOPs, including Protein Concentration by A280, SEC-HPLC, peptide mapping, N-glycan, CE-SDS NR/R, iCIEF
Ensure that all analytical data from the laboratory is accurate, precise, robust and is generated by following methods, specifications and procedures
Ensure compliance to training, testing, documentation and general lab maintenance requirements for industry standards and/or regulations
Prepares validation documents to support new products, process changes and qualifications
Handle up to 2 projects at the same time, coordinate the internal and external resources of the project, effectively control the key nodes, progress and deliverables of the project (in line with the scope of the contract)
Introduct established work processes and standard operations to new employees to help them complete their tasks. Able to train others on intermediate assays
As FL or co FL, lead a project team of 2-3 people and ensure clear division of labor and clear responsibilities
Generate documents such as, SOPs, analytical methods, and On The Job training and trains junior staff on methods
Optimize methods to improve efficiency while adhering to Quality Control standards
Troubleshoot any issues on assays, instrument, or reagents
Investigate any OOS/OOT and atypical results and laboratory investigations, conduct root cause analysis, and implement CAPA
Attend internal and external meetings and present data summary, investigation results, or trending analysis to project teams or clients
Proactively respond to and participate in scheduled audits and able to defend methodologies to auditors
Qualification
Required
Bachelor or advanced Graduate degree (MS/PhD) in Chemistry, Microbiology, Biochemistry or equivalent field
Bachelor's degree: at least 4-6 years of experience in field
Master's degree: at least 2-4 years of experience in field
PhD: No requirement
Candidate must possess 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
Strong technical and scientific knowledge of general QC testing
Hands-on experience in modern analytical instruments for protein analysis, such as Size Exclusion Chromatography, Peptide Mapping, Polysorbate 80 Quantitation, Capillary Electrophoresis, Imaged Capillary Isoelectric Focusing (iCE3 and Maurice), Protein Concentration by A280
Ability to process, evaluate and summarize technical data. Ability to draft method qualification/transfer protocols and reports, analytical procedures, data summary and data trending analysis report
Provides training on areas of technical expertise and compliance issues relevant to the lab setting
Working experience with performing industry investigations/deviations
Strong working experience with analytical method validations
Working experience with training analysts on new transferred methods
Working experience within cGMP industry
Previous experience using GMP Quality Systems (ex. TrackWise)
Experience with lab-based software systems such as: LIMS, Empower, LabX
Ability to answer audit questions and address audit comments
Ability to lead analytical support for multiple iCMC and standalone projects
Ability to manage timeline and resources for project support
Excellent communication skills with the ability to collaborate across multiple teams and projects
Experience with speaking publicly. Able to maintain control of meetings as required
Proven experience in risk mitigation planning and ability to solve complex QC technical and operation problems. Be able to make appropriate judgment and decisions based on available knowledge and data to ensure the safety and success of the manufacturing support and product testing
Proficiency in English is required. Excellent communications skills (verbal, written, and presentation skills). Must be able to collaborate with clients, internal stakeholders, and support functions to achieve alignment and work effectively
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
2026-01-14
Company data provided by crunchbase