As QC Microbiology Lead (Associate Director) you 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 product testing and Environmental Monitoring teams. Working closely with 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.
Organisation Description
WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) 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 Microbiology Lead (Associate Director) 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 Director (Head of Quality Control).
Your Responsibilities
- Key member of the QC leadership team for WuXi 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 leaders to ensure work practices and targets are achieved in line with the business targets and objectives.
- The role will require extensive liaison with counterparts and business leaders in WuXi 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.
- Provide the highest quality microbiological support for Biologics manufacturing, while ensuring compliance with cGMP guidelines/regulations, company SOPs, and safety regulations.
- Key responsibilities will include:
- Leading a large QC microbiology laboratory to support all micro activities associated with bio manufacturing process.
- Ensure all resources are planned to ensure consistent support to day-to-day activities.
- Management of micro testing including bioburden, sterility, endotoxin, water/chemical testing, microbial organism identification testing etc.
- Support of microbiology methods associated with raw material, in-process and release testing.
- Facility, utilities and laboratory equipment qualification.
- Cleaning and process validation support.
- Development and review of environmental and utilities trend reports and provide relevant technical support and guidance.
- Leads all QC micro activities associated with method transfer, validation, and troubleshooting
- Develop KPIs for the QC microbiology lab and report regularly on metrics, identify associated opportunities for improvement as necessary.
- Provide technical expert in all environmental and micro investigations including microbial contamination and adverse trends utilising an established CAPA process this will include out of spec (OOS), deviations, change controls through prescribed validation process.
- Ensure all analytical protocols, policies and procedures are developed and adhered to
- Support the development of specific aseptic techniques and microbiology awareness and provides meaningful input to processing operations in collaboration with other functional areas.
- Perform and participate in any required Quality Risk Assessments for projects and business innovation initiatives from a microbiological perspective.
- Communicate, collaborate, and cooperate with QC functional teams and other departments to support lab start-up and routine operations
- In conjunction with manufacturing, help improve training related to microbiological hygiene and contamination prevention
- 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.
- Ability to handle regulatory inspections from FDA, EMA, etc. and cGMP audits from clients, as well as internal audits.
- Anticipating and planning for future requirements in both Manufacturing and the QC area
- 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.
- 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.
- Perform all duties in accordance with GMP requirements, SOPs and controlled documents
- Flexibility to take on additional tasks and responsibilities at the discretion of the QC Director
- Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values and PROUD culture.
Person Specification
Technical Competencies
- Ideally, experienced in establishing a QC function and building a team in a ‘greenfield’ context of similar size and scale.
- Technical expertise in tech transfer, validation, and troubleshooting Biologics product-testing methods, including Bioburden and endotoxin testing, sterility testing and microbial identification, etc. to support QC release and stability testing in a GMP-environment according to USP, EP, and ChP requirements.
- Demonstrating direct experience as QC Micro Lead in regulatory inspections from FDA, EMA, etc. and GMP audits from clients, as well as internal Quality Assurance.
Experience
- Demonstrated strong experience working within a Quality Control environment, with a well-rounded exposure to all areas in this field.
- Experience working in the Biologics manufacturing industry is preferred.
- Experience leading a large team of QC professionals during startup is preferred and sustaining phase a key requirement for this role is essential.
- Experience with LIMS, Empower, ECM, Master Control, Trackwise or similar systems is required.
- Experience with Microsoft Word, Excel, Powerpoint, Visio, and Project
- Managing and leading a group of employees with particular attention to schedules and shifting priorities is required and demonstrating leadership competencies.
- Demonstrate Microbiology SME within a Quality Control/GMP environment is required
- 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.
- Possesses detailed knowledge of routine and non-routine testing and sampling methods, techniques and related equipment.
Qualifications
- University degree in related science/quality discipline is required.
- Chemistry, Analytical Chemistry, Biochemistry, Biology, Molecular Biology is preferrable qualification, other related and equivalent qualifications will be considered.
Behavioural Competencies
- Excellent interpersonal, verbal, and written communication skills
- Ability to think critically and demonstrate troubleshooting and problem-solving skills
- Self-starter and self-motivated; organised 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
Onerous requirements
- Up to 15% domestic and international travel
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 can 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 mission - 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/
WuXi Biologics is an equal opportunities employer.
