Scientist II, Quality Control - Project

Job Title – Scientist l/II, Quality Control

Job 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 Summary

Supports Quality Control clients related integrated, standalone or related QC department projects and ad hoc work. Work closely and collaborate with external departments such as PM and CMC leaders with QC internal testing functions to ensure smooth orderly management of QC methods and timelines. Responsible for overall QC projects deliverables and meeting clients’ expectations regarding projects’ completions and IND filings. Responsible as the function lead to managing specific QC projects’ communications and deliverables to clients. Demonstrates strong oral and written communication skills and actively contributes to project training, reports/COAs/COTs generation and documentation. Supports the QC Operations group in RS/Stability/inventory management.

Essential Job Functions

• Lead multiple matrix teams involving Analytical development, QC testing teams to establish and accomplish method transfer and Qualification Strategy.
• Ability to work effectively as part of a cross functional team comprising of PD, MSAT, MFG, AD, QA and PM team and exhibit effective interpersonal skills.
• Manage QC method transfer and Qualification testing in a timely fashion.
• Ensure compliance to training, testing, documentation and general lab management requirements for Industry Standards and/or Regulations.
• Prepares Sampling Plans, Specification, Release/Stability testing protocols in a timely fashion. 6. Manages in process, QC release and stability testing.
• Manages Cell bank testing with internal and external clients.
• Manages selection of external CRO and sample shipment.
• Participate in any Investigation of Out-of-Specification results and laboratory deviations, root cause analysis, and implementation of CAPA.
• Support QC sample management, reference standard management, and stability sample management, including but not limited to receiving, aliquoting, distributing, tracking, and disposing of QC testing samples/stability samples.
• Support QC sample management, reference standard management, and stability sample management, including but not limited to receiving, aliquoting, distributing, tracking, and disposing of QC testing samples/stability samples.
• Support QC lab inventory management, including but not limited to QC lab inventory ordering, receiving, storage,distribution, inventory tracking by using either paper-based forms or LIMS inventory module, and generating inventory-related monthly report.
• Acts as support for archiving QC testing worksheets, laboratory notebooks, and equipment logbooks in a timely manner
• Effective multi-tasking skills and time management required.
• Effectively communicates with internal and external clients on project related matters, lead technical discussion.
• Participate in preparation of project-related audits when needed.
• Participate in QC lab organizational excellence project.
• Able to cope with fast paced environment and being proactive.
  
  
  
  

Experience / Education

• Bachelor or advanced Graduate degree in Biology, Cell Biology, or equivalent field.
• A least 3 years of relevant experience or equivalent for Bachelors’, 2 years for Master’s in the Quality Control or related field or equivalent experience.
• PhD with 0-1 years of relevant experience
  
  
  
  

Knowledge / Skills / Abilities

• 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.
  
  
  
  

The anticipated salary range for this position is $60,200 to $96,300

WuXi Biologics is 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.