WuXi Biologics is a premier provider of biologics services (from discovery to commercialization) with global customers in the biopharmaceutical and healthcare industries. We´re one of the world's top three contract development and manufacturing companies for biopharmaceuticals, we provide our clients with a world-leading open access technology platform. We enable our clients to research, develop and manufacture drugs from the concept phase to commercial manufacturing.

Our mission is to accelerate and transform discovery, development, and manufacturing in the rapidly growing field of biologics to benefit patients worldwide. We have sites/offices in China, the US, the EU, and Asia. We currently employ over 10,000 people and provide services to more than 600 customers worldwide, including the top 20 biopharmaceutical companies.

Key Responsibilities

Lead the Raw Materials and Compendial testing teams, including hiring, onboarding, mentoring, and performance evaluations.
Supervise, plan, and coordinate daily work schedules and resource assignments for staff.
Partner with the QC Head to manage budgeting for manpower, supplies, and equipment.
Oversee all RM and compendia testing activities to ensure product quality and timely delivery of results.
Establish and monitor Operational Metrics and Service KPIs to ensure department objectives are met.
Direct continuous improvement initiatives focused on quality, cost savings, and process efficiency.
Provide guidance on analytical method qualification/validation and troubleshoot laboratory issues.
Review and approve SOPs, validation protocols, investigations (OOS/OOL), and specifications.
Ensure all laboratory procedures comply with GDP, cGMP, CFR, and/or PIC/S guidelines.
Draft and review relevant CMC sections for regulatory submissions (e.g., BLAs).
Serve as the Site Point of Contact (POC) and SME for RM and Compendia topics.
Participate in Global Center of Excellence (COE) meetings to align site practices with global standards.
Develop and oversee QC training programs to ensure team proficiency in cGMP and specialized testing techniques.

Requirement

Bachelor of Science degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
6 - 8 years of relevant experience in QC in biopharmaceutical industry and 2 years of Management experience is required. .
Knowledge of GMP regulations, ICH regulations and pharmacopoeia (EP/USP/ChP, etc) for Incoming materials/Raw material (RM)/Compendia specification generation.
Subject matter expertise (SME) and hands-on proficiency with all aspects of pharmaceutical RM control.
Experience and understanding RM regulations and guidelines with in-depth understanding of cGMP.
Experience in validating and executing RM testing methods, identification methods, and evaluating new technology or methods.
Be proficient in technique and principle of compendial testing, including pH, Osmolality, Clarity, extractable volume, visible particles, Color, Subvisible particulate Matter, etc.
Experience with application of root cause analysis tools for investigation execution.
Experience with Quality Systems (e.g. Document/Quality/Learning management system, Change Control, Deviations, and CAPA programs).
Able to rapidly pivot between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.

APPLY NOW

As we extend our global reach, we are looking for talent interested in change, in challenge, and in building a new future together. Reach beyond yourself and discover your true potential.

If you have the ability to thrive in a dynamic and fast-paced environment and feel that the moment has come for you to be part of such an exciting journey towards accomplishing our vision - Any drug can be made, and any disease can be treated - don't miss out on this opportunity to join us and reach beyond yourself and discover your true potential.

Quality Control Principal Specialist, Raw Materials & Compendial