As a QC Separations Lead, Associate Director, will play a pivotal role in ensuring the highest standards of professional excellence, regulatory adherence and quality within the business, with overall responsibility for the management of separations product-testing teams, including HPLC, CE, and c IEF. Working closely with senor leaders in all areas of the business, this position will play an integral role in the development of the local QC strategy/business planning, aligned closely with the global QC function.

Organization Description

Wu Xi 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 a QC Separations Lead, Associate Director, you’ll be joining an organization 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 Director.

Your Responsibilities

• Key member of the QC leadership team for Wu Xi Biologics Ireland. Will play an integral role in the strategy and business planning processes, ensuring cross functional collaboration and leadership execution.
• Work closely with all senior leaders to ensure work practises and targets are achieved in line with the business targets and objectives.
• The role will require extensive liaison with counterparts and business leaders in Wu Xi Biologics corporate to include the highest level of professional representation of the local site QC organisation.
• From a QC functional capacity support the design, construction, and commissioning of the new facility for the production of drug substance.
• Develop/build a world-class Biologics QC separations product-testing team (HPLC, CE, and c IEF) including planning, recruiting/hiring, coaching/mentoring, and training for approximately 15 total headcount.
• Provide the highest quality analytical support for Biologics manufacturing, while ensuring compliance with c GMP guidelines/regulations, company SOPs, and safety regulations.
• Interact with internal and external partners, clients, and inspectors and maintains high quality standards and services
• Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations
• Serve as a technical lead supporting applicable non-conformances, atypical/OOS investigations, change controls, deviations, and CAPAs
• Lead the group to meet the pre-determined goal/budget of the department through streamlining/optimizing the workflow and maximizing the operation efficient while maintaining full compliance
• Provide effective communication and play a leading role in project management interaction with internal and external clients such as Quality Assurance, Regulatory Affairs, and Analytical Development
• 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.
• Introduce new technologies and seek opportunities for continuous process improvements/improved operational excellence
• Ensure QC staff receive appropriate GMP training and maintain compliance and high-quality standards
• Create a safety culture, enforce safety measures and ensure QC staff working in a safe environment
• Ability to work in a team environment and independently as required
• Ensure the tasks associated with the start-up and routine operations applicable to the role are carried out in a safe manner
• Enhance collaborations by sharing knowledge and experiences across Wu Xi Biologics global sites
• Will be flexible to take on additional tasks and responsibilities at the discretion of the Engineering Director.
• Will act as a role model for the Engineering function and the wider organisation in adherence to the Wu Xi corporate core values and local site shared commitments/behaviours.

Person Specification

Technical Competencies

• Ideally, experienced in establishing a QC function and building a team in a 'greenfield' context of similar size and scale.
• Ability to handle regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.
• Prepare, review, and approve technical documents including method protocols, qualification and validation protocols and reports, etc.
• Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including HPLC, CE, and c IEF to support QC release and stability testing in a GMP-environment according to USP, EP, and Ch P requirements.

Experience

• 15+ years of experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field. Experience working in the Biologics industry is essential.
• Experience with LIMS, Empower, ECM, Master Control, Trackwise, or similar systems is required.
• Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project is required.
• Management/supervision of personnel with particular attention to schedules and shifting priorities is required and demonstrated leadership skills.
• Previous experience in a Quality Control/GMP environment is required.
• Previous experience with regulatory inspections and internal/customer audits is strongly preferred.
• Previous experience working in a CMO is a plus.

Knowledge

• Knowledgeable of FDA/EMA regulatory requirements and ICH and GMP guidelines applicable to biologics and/or pharmaceuticals.

Qualifications

• University degree in related science/quality discipline required.
• Ph.D. with 5+ years of experience, or Masters with 7+ years of experience in Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology, Engineering, IT, or other related field, desired.

Behavioural Competencies

• Excellent interpersonal, verbal, and written communication skills.
• Able to think critically and demonstrate troubleshooting and problem-solving skills.
• Self-starter and self-motivated; organized with good attention to detail.
• Comfortable working in a fast-paced environment and able to adjust workloads based on changing priorities.
• Results oriented, with the ability to manage multiple priorities in a short period of time.

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.

Apply now!

Would you like to know more before you apply? Please visit us at https://www.wuxibiologics.com/join-us/ or contact us via talentacquisition@wuxibiologics.com

Wu Xi Biologics is an equal opportunities employer.