QC BioassayBiochemical Assay Lead

As QC BioAssay/Biochemical Assay 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 teams including bioassays and biochemical assays.

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.

Organisation Description

WuXi Biologics is a premier provider of biologics services (from discovery to commercialisation) with global customers in the biopharmaceutical and healthcare industries. Were one of the worlds 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 10000 people and provide services to more than 600 customers worldwide including the top 20 biopharmaceutical companies.

Department Description

As QC BioAssay/Biochemical Assay Lead (Associate Director) youll 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 youll 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 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 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.
• Develop/build a world-class Biologics QC bioassays and biochemical assays product-testing team including planning recruiting/hiring coaching/mentoring and training for 15-20 total headcount.
• Provide the highest quality analytical support for Biologics manufacturing while ensuring compliance with cGMP 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
• Prepare review and approve technical documents including method protocols qualification and validation protocols and reports etc.
• 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 WuXi Biologics global sites
• Will be flexible 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 the wider organisation in adherence to the WuXi 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.
• Technical expertise in tech transfer validation and troubleshooting Biologics product-testing methods including cell based bioassay PCR ELISA enzyme activity Western Blot SDS-PAGE etc. to support QC release and stability testing in a GMP-environment according to USP EP and ChP requirements.
• Ability to handle regulatory inspections from FDA EMA etc. and GMP audits from clients as well as internal Quality Assurance.

Experience

• 15 years 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
• 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 5-8 years of experience or Masters with 7-10 years of experience in Chemistry Analytical Chemistry Biochemistry Biology Molecular Biology Engineering IT or another 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 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- dont 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 Biologics is an equal opportunities employer.