QC Raw Materials & Compendial Scientist

WuXi Biologics; Leinster; On-site; EUR 65,000 - 90,000; Full time

Job summary

WuXi Biologics is seeking a QC Raw Materials and Compendial Scientist to support GMP/GLP compliant testing and release of raw materials, contributing to quality systems and regulatory readiness.

The role requires experience in QC labs within biopharma, knowledge of pharmacopeia methods, and ability to work in a fast-paced team while coordinating with cross-functional groups. Shift work and travel may be required.

Qualifications

• University degree in related science/quality discipline required.
• Experience in a Quality Control/GMP environment is required.
• Familiarity with pharmacopeia testing methods and regulatory requirements is desirable.

Responsibilities

• Ensure startup and routine operations of the QC lab are performed safely.
• Support lab setup, equipment installation, and qualification.
• Develop and maintain quality systems to ensure GMP/GLP compliance.
• Lead QC test method validation and development of testing strategies.
• Author technical documents including protocols and SOPs.
• Handle regulatory inspections and client audits; participate in internal audits.

Skills

GMP knowledge

Regulatory awareness

Analytical testing

Team collaboration

Education

Bachelor's degree in science

Job description

As QC Raw Materials and Compendial Scientist, you’ll will be responsible for carrying out tasks and supporting projects related to the QC testing and release of raw materials ensuring that the highest standards of GMP, GLP and Regulatory are strictly adhered to.

Organisation Description

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.

Department Description

As QC Raw Materials and Compendial Scientist, you’ll be joining an organisation where people of all backgrounds and experiences are respected, and where we work together focused on changing lives. In this role you’ll be reporting to the QC Raw Materials and Compendial Associate Director.

Your Responsibilities

In this role, you will be responsible for the following:

• Ensure the tasks associated with the startup and routine operations of a QC Raw Materials and Compendial laboratory are carried out in a safe manner.
• Support QC Raw Materials and Compendial laboratory set-up, including laboratory design, equipment installation and qualification utilizing principles of Operational Excellence and Lean Labs.
• Support facility qualification, process validation, etc.
• Develop and maintain quality systems within the QC Raw Materials and Compendial laboratory to ensure compliance to GMP / GLP.
• Development of training material for the QC Raw Materials and Compendial laboratory personnel.
• Support and lead QC test method validation and development of routine testing strategies when required.
• Perform additional duties at the request of the direct manager.
• Routine monitoring of laboratory KPI’s, stock control of laboratory consumables and reagents and support for future expansion/upgrade projects.
• Support QC Senior scientist in OOS, OOL, adverse trends, any excursion investigations, change controls, and CAPAs tasks.
• Author technical documents including methods protocols, qualification/ validation protocols and reports, SOPs, etc.
• Keep abreast of current corporate and regulatory trends and requirements pertaining to laboratory operations.
• Develop and maintain high level of scientific achievements for the company; expected to be a point of contact for project coordination, including email and client meetings.
• Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
• Participate in relevant internal and external QC related audits.
• Ability to work in a team environment and independently as required.
• Train other QC analysts and manufacturing personnel in laboratory methods and procedures when required.
• Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics Policies and Standard Operating Procedures.
• Thorough understanding of current Good Manufacturing Practices
• Perform additional duties at the request of the direct manager.

Your Profile

The ideal candidate for this position, will have the following:

• Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
• Familiarity with Pharmacopeia testing methods and requirements.
• Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals; ICH and GMP guidelines desirable.
• Experience with regulatory/customer audits is desirable.

Experience

• Experience in a large-scale Biopharmaceutical/pharmaceutical facility.
• Experience with facility start-up projects (brown field or green field) is desirable.
• Experience in Training of personnel.
• Previous experience in a Quality Control/GMP environment is required.

Knowledge

• Knowledge of analytical testing in support of biopharmaceutical manufacturing is preferred but not required.

Qualifications

• University degree in related science/quality discipline required.
• Excellent communication, interpersonal and presentation skills.
• Ability to think critically and demonstrate troubleshooting and problem-solving skills.
• Comfortable in a fast-paced working environment and able to adjust workload based upon changing priorities.
• Collaborative and inclusive approach to work and your colleagues.
• Flexible approach to work and a positive attitude will be a good fit within the team dynamic.
• Engage cross functionally in conjunction with a site-based team.
• Autonomous and a self-starter who will use their initiative to drive actions forward.
• Demonstrate strong ethics in adhering to company procedures and policies, regulatory standards, and our customers' expectations.
• Shift work and business travel may be required for this position as directed by departmental management.

As we extend our global reach, we need colleagues 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.

WuXi Biologics is an equal opportunities employer.