WuXi Biologics
Senior Associate Scientist, QC Testing - Raw Materials & Compendial
WuXi Biologics, Cranbury, New Jersey, United States,
Scientist II – QC RM FL / Testing - Raw Materials & Compendial (RMC)
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
The QC RM FL (Functional Leader) /Testing Scientist is responsible for the quality and on-time delivery of test results 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.
Responsibilities:
Able to conduct Raw Materials (RM) and Compendia assays and execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs.
Able to lead the team to prepare and track the schedule of raw material activities and ensure that the raw material part of the project is carried out and released timely.
Able to participate as RM FL (Functional leader) and attend assigned RM projects meetings in the CMC team meetings internally and externally with clients anytime.
Oversee and manage raw material-related projects; plan and execute RM analytical method development, verification/validation, and transfer; release testing as well as other work within the scope of RM.
Management of Raw Material analytical testing lab daily work with supervisor (when needed), including staff development, daily operation and cGMP compliance, audit/inspection by regulatory agencies such as FDA/EMA/CFDA etc.
Ensure that all analytical data from the laboratory is accurate, precise, robust, and contemporaneous and is generated by following GMP methods, specifications, and procedures.
Being compliance with training, testing, documentation, and general lab maintenance requirements for Industry Standards and/or Regulations.
Draft and prepare 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.
Maintain laboratory notebooks and worksheets for QC tests; uphold good GMP reviews in these GMP documents.
Support raw material sampling (when necessary) according to sampling plan and specifications.
Any other duties assigned by the supervisor (when applicable).
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 requirements including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Solid track record of working experience in quality control operations to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
Introduce established work processes and standard operations to new employees to help them complete their tasks. Able to train others on basic assays.
Ability to proficiently use advanced laboratory equipment.
Hands-on experience with analytical instruments and methodologies, such as HPLC, Densitometer, Colorimeter, Turbidimeter, HIAC/Subvisible particles, FTIR, pH, Karl Fisher, and potentiometric titration.
Experience with a wide variety of software and information systems (e.g. Empower, TrackWise, Master Control, and preferably LIMS). 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.
Problem Solving:
Ability to identify and solve routine problems based on past experience. Able to make suggestions for improvement of specific tasks or operating procedures and implement them.
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.
Be able to raise issues immediately to the supervisor when in doubt.
Communication Skills:
Proficiency in English is required. Excellent communication skills (verbal, written, and presentation skills).
Effectively exchange information or discuss clearly framed issues or ideas with colleagues.
Qualifications:
Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
Bachelor's degree: 4+ years of experience in the professional field.
Master's degree: 2+ years of experience in the professional field.
Familiar with theory, practice, and procedures required to complete work tasks.
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.
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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
The QC RM FL (Functional Leader) /Testing Scientist is responsible for the quality and on-time delivery of test results 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.
Responsibilities:
Able to conduct Raw Materials (RM) and Compendia assays and execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs.
Able to lead the team to prepare and track the schedule of raw material activities and ensure that the raw material part of the project is carried out and released timely.
Able to participate as RM FL (Functional leader) and attend assigned RM projects meetings in the CMC team meetings internally and externally with clients anytime.
Oversee and manage raw material-related projects; plan and execute RM analytical method development, verification/validation, and transfer; release testing as well as other work within the scope of RM.
Management of Raw Material analytical testing lab daily work with supervisor (when needed), including staff development, daily operation and cGMP compliance, audit/inspection by regulatory agencies such as FDA/EMA/CFDA etc.
Ensure that all analytical data from the laboratory is accurate, precise, robust, and contemporaneous and is generated by following GMP methods, specifications, and procedures.
Being compliance with training, testing, documentation, and general lab maintenance requirements for Industry Standards and/or Regulations.
Draft and prepare 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.
Maintain laboratory notebooks and worksheets for QC tests; uphold good GMP reviews in these GMP documents.
Support raw material sampling (when necessary) according to sampling plan and specifications.
Any other duties assigned by the supervisor (when applicable).
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 requirements including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
Solid track record of working experience in quality control operations to support clinical and commercial scale manufacturing product testing and regulatory IND/BLA filing.
Introduce established work processes and standard operations to new employees to help them complete their tasks. Able to train others on basic assays.
Ability to proficiently use advanced laboratory equipment.
Hands-on experience with analytical instruments and methodologies, such as HPLC, Densitometer, Colorimeter, Turbidimeter, HIAC/Subvisible particles, FTIR, pH, Karl Fisher, and potentiometric titration.
Experience with a wide variety of software and information systems (e.g. Empower, TrackWise, Master Control, and preferably LIMS). 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.
Problem Solving:
Ability to identify and solve routine problems based on past experience. Able to make suggestions for improvement of specific tasks or operating procedures and implement them.
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.
Be able to raise issues immediately to the supervisor when in doubt.
Communication Skills:
Proficiency in English is required. Excellent communication skills (verbal, written, and presentation skills).
Effectively exchange information or discuss clearly framed issues or ideas with colleagues.
Qualifications:
Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
Bachelor's degree: 4+ years of experience in the professional field.
Master's degree: 2+ years of experience in the professional field.
Familiar with theory, practice, and procedures required to complete work tasks.
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.
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