WuXi Biologics Hiring for Senior Scientist I, Quality Control job in Cranbury Full Time

The QC Testing Senior Scientist is a senior member of the QC department to support method transfer, validation, deviation support, and investigation projects. This role is responsible for the quality and on-time delivery of test results, validation data and other QC deliverables to internal and external clients and will be the Subject Matter 

Job Functions

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

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
Investigate any Out-of-Specification results and laboratory deviations, conduct root cause analysis, and implement CAPA.

Prepares validation documents to support new products, process changes and qualifications.Participates in project team meetings.
Train junior staff on new methods from tech transfers.

Job Requirement

Technical Skills / Knowledge:

• 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, such as HPLC, UPLC, CE, iCE, ELISA, and Bioassays.
• Ability to evaluate technical data
• 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, Softmax; including validation of templates within these systems.
• 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.

Problem Solving:

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.

Communication Skills:

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.

Education and Experience:

• Bachelor or advanced Graduate degree (MS/PhD) in Chemistry, Microbiology, Biochemistry or equivalent field.
• A least 8+ years of relevant experience or equivalent for Bachelors’, 5+ years for Master’s in the Quality Control or related field or equivalent experience.