Senior Scientist I, Quality Control

WuXi Biologics Group; New Jersey; On-site; USD 100,000 - 130,000; Full time

Job summary

A global biologics technology platform is seeking an Associate Director of Organization Development & Employee Relations. This strategic HR leader will enhance organizational culture, optimize workforce effectiveness, and manage employee relations. Candidates should have a relevant degree and extensive experience in micro assay and analytical testing. The role emphasizes driving engagement and building trust across the organization.

Qualifications

• Extensive experience in micro assay, RM assay, analytical assays.
• Ability to draft quality events and complete work within timelines.
• Able to work on weekends and support shift work when needed.

Responsibilities

• Drive initiatives that strengthen organizational culture and workforce effectiveness.
• Optimize methods to improve efficiency while adhering to Quality Control standards.
• Investigate OOS/OOT results and implement CAPA.

Skills

Micro assay

RM assay

Analytical assays

GMP guidance

Multi-tasking

Education

Full-time undergraduate degree or above in biology or related field

Bachelor's degree: 9-11 years of experience

Master's degree: 7-9 years of experience

PhD: 2-4 years of experience

Job description

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 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.

Overview

Position Overview

The Associate Director of Organization Development (OD) & Employee Relations (ER) is a strategic HR leader responsible for driving initiatives that strengthen organizational culture, optimize workforce effectiveness, and foster an engaging, high-performance workplace. This role combines expertise in organization development with deep employee relations acumen to shape programs that enhance leadership capability, employee engagement, and workplace equity while proactively managing employee relations to minimize risk and build trust across the organization.

Key Responsibilities

• Understand GMP and follow instructions on the documents.
• Perform micro, raw materials, compendia related testing including but not limited to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate, execute lab procedures according to and in compliance with cGMP guidelines and internal SOPs.
• Receive required samples, perform testing, plate reading, plate transferring, report results independently and in a timely manner.
• Conduct EM/water/gas sampling in cleanroom areas in/between the various building sites in Cranbury or other US sites (when needed).
• Support RM sample sampling and its transporting needs in/between the various building sites in Cranbury or other US sites (when needed).
• Management of raw material, EM monitoring samples, raw material sampling room, sample storage room and regulatory retain sample room, etc., and ensuring the sampling process and storage of raw material samples or incubation of EM samples are conducted properly and within control.
• Support reagents/consumables inventory/invoices management to ensure consistent QC Micro/RM/Compendia operation needs.
• Ensure that all data from the laboratory is in accordance with good GDP practices to ensure data integrity.
• Ensure compliance with training, preparation, documentation and general lab maintenance requirements for Industry Standards and/or Regulations.
• 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.
• Preparing or executing validation documents to support new materials, process changes and qualifications.
• 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.
• Any other duties assigned by the supervisor (when applicable).

Qualifications

• Full-time undergraduate degree or above, majoring in biology, chemical engineering, chemistry, pharmacy or related majors.
• Bachelor's degree: at least 9-11 years of experience in the professional field.
• Master's degree: at least 7-9 years of experience in the professional field.
• PhD: at least 2-4 years of experience in the professional field.
• Extensive experience in micro assay, RM assay, analytical assays.
• Ability to generate protocol and report independently.
• Ability to follow GMP guidance and all QC general SOPs.
• Ability to draft SOP or AMP for operating equipment and performing analytical testing.
• Ability to document and review experiments following GDP and ALCOA+ principles.
• Ability to perform and review data analysis/work independently.
• Ability to conduct basic troubleshooting.
• Ability to draft quality events, including lab investigation and deviation.
• Ability to complete work within pre-defined timeline. Effective multi-tasking skills and time management required.
• Ability to draft EM trending report independently.
• Able to provide suggestions to update and optimize AMPs/sampling plans accordingly.
• Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
• Ability to understand technical data.
• Able to work on the weekend when needed.
• Support shift work when needed.
• Basic experience in planning and ability to solve simple technical and operation problems.
• Able to raise issues immediately to supervisor and work with supervisor when doubt.

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