To apply, please also email your resume to MFG18Careers.US@wuxibiologics.com
The following job description applies to the position, department and business unit as stated below:
Job Title: Scientist – QC Analytical Testing
Location: New Jersey , US
Site/Department: Cranbury MFG 18/QC
Business Unit or Division: WuXi Biologics Development
Line Manager: QC Manager or higher, MFG18
II. Job Summary
The QC Testing Scientist is responsible for the quality and on-time delivery of test results, validation data and other QC deliverables to internal and external clients. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and documentation.
III. Job Functions
- Work cross-functionally with Analytical Development to qualify and transfer developed assays.
- 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
- Prepares SOP, protocols, final reports, investigations, and deviations as needed
- 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.
- Maintains a laboratory notebooks and worksheets for QC tests as required; reviews and signs laboratory notebooks and worksheets
- Receives minimal instructions on routine work and detailed instructions on new assignments.
IV. Job Requirement
Technical Skills / Knowledge:
- Candidate must possess knowledge and experience in analytical 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.
- Strong technical and scientific knowledge of general analytical testing.
- Ability to use proficiently advanced laboratory equipment
- Hands-on experience in modern analytical instruments, such as HPLC, CE, iCE, ELISA, qPCR, and cell-based assays.
- Experience with a wide-variety of software and information systems (e.g. Empower, GxP Softmax Pro, and Statistical analysis).Ability to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
- Ability to evaluate technical data
- Provides training on areas of technical expertise and compliance issues relevant to the lab setting.
- 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.
- PhD of science degree in Chemistry, Microbiology, Biochemistry or equivalent field.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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.