QC Raw Materials & Compendial Scientist

About WuXi Biologics

WuXi Biologics is a leading global contract development and manufacturing organization for biopharmaceuticals, with customers spanning discovery to commercialization phases. The company operates worldwide with locations in China, the US, Europe, and Asia, employing over 10,000 professionals and serving more than 600 clients, including top biopharma firms. Our mission focuses on accelerating biologics discovery, development, and manufacturing to improve patient outcomes globally.

Role Overview

The position of QC Raw Materials and Compendial Scientist requires overseeing tasks and projects linked to the QC testing and release of raw materials, ensuring strict adherence to GMP, GLP, and regulatory standards in a biologics manufacturing context.

Key Responsibilities

• Ensure safe execution of start-up and routine QC Raw Materials and Compendial laboratory activities.
• Assist in setting up the laboratory, including design, equipment installation, and qualification using Operational Excellence and Lean Lab practices.
• Support qualifications of facilities and process validations.
• Develop and maintain quality management systems compliant with GMP and GLP within the laboratory.
• Create training materials for laboratory staff.
• Lead and support validation of QC test methods and routine testing strategies as needed.
• Conduct routine monitoring of lab KPIs, manage inventory of consumables and reagents, and assist future lab expansion projects.
• Assist senior scientists in investigations related to OOS, OOL, adverse trends, excursions, change controls, and CAPA activities.
• Author technical documentation including methods, protocols, validation reports, and SOPs.
• Stay updated on evolving corporate, regulatory, and industry laboratory requirements.
• Serve as a scientific liaison for project coordination including client communications.
• Manage regulatory inspections (FDA, EMA) and internal and client audits.
• Train QC analysts and manufacturing personnel on laboratory procedures when necessary.
• Maintain compliance with applicable regulations, international standards, company policies, and SOPs.

Required Skills and Experience

• Strong understanding and practical experience with routine and non-routine QC testing and sampling techniques and equipment.
• Knowledge of Pharmacopeia testing methods and regulatory requirements including FDA, EMEA, ICH, and GMP guidelines relevant to biologics and pharmaceuticals.
• Experience in large-scale biopharmaceutical or pharmaceutical environments.
• Familiarity with facility startup projects (both brownfield and greenfield) is a plus.
• Experience training personnel in QC or GMP settings.
• Prior experience working in a Quality Control and GMP environment is essential.
• Analytical testing knowledge supporting biopharmaceutical manufacturing preferred, though not mandatory.

Education

A university degree in a relevant scientific or quality discipline is required.

Behavioral Competencies

• Exceptional communication, interpersonal, and presentation abilities.
• Strong critical thinking with capacity for troubleshooting and problem solving.
• Adaptability to fast-paced environments and changing priorities.
• Collaborative, inclusive, and flexible work attitude.
• Capability to operate autonomously and take initiative.
• Demonstrated ethical standards in compliance with company, regulatory, and customer expectations.
• Effective cross-functional teamwork within a site-based team.

Other Information

• Shift work and business travel may be necessary based on managerial direction.

Joining WuXi Biologics offers the chance to contribute to a transformative journey focusing on advancing biologics manufacturing and patient treatment worldwide.