A true single-source provider from concept to commercialization for biologics produced from mammalian cell culture.
Discover information about the various drug development services we provide for this product type.
Recombinant Proteins / Enzymes / Cytokines.
High quality, expert services for biologics produced from microbial fermentation.
Industry-leading expertise, state-of-the-art facilities, and multiple antibody generation technology platforms for the discovery of novel monoclonal, bispecific and multispecific antibodies, immunocytokines and other biologics.
Specializing in monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and other biologics, we offer our customers high productivity and high quality antibody and protein production services for all of your research needs.
We unite expert protein engineering capabilities with our high throughput and high productivity research-scale protein production services to enable all of your R&D initiatives.
Provided as either a standalone service offering or as part of our integrated CMC development platforms, WuXi Biologics provides extensive expertise and industry-leading timelines for cell line engineering and strain development across a wide range of biotherapeutics.
Our extensive analytical testing services offer top-tier expertise in method development for in-process, release, and stability assays, and support of cell line, process, and formulation development activities, product characterization, developability assessments and other key IND- and BLA-enabling studies.
Multiple upstream and downstream PD labs facilitate the establishment and scale-up of fed-batch, intensified fed-batch, and continuous manufacturing approaches for diverse biotherapeutic modalities in both early and late-stage development.
Late-Stage Development and Process Characterization
We provide late-stage development and manufacturing services with advanced technology and a global network that ensures GMP manufacturing and rapid BLA filing.
We provide advanced drug product development services spanning biologics, vaccines, and small molecules, with expertise in formulating clinical and commercial products in liquid, frozen, and lyophilized forms, compatible with various container closure systems such as vials, prefilled syringes, and other combination product types.
Offering in-house, one-stop cell banking and cell line characterization services, compliant with global GMP regulations and ICH guidelines, we operate over 20 cGMP cell banking suites ensuring capacity availability and timely execution of this critical CMC development activity.
Our extensive experience and expertise, along with EMA, ISO (CNAS), and CMA-certified laboratories, and exceptional track record for IND- and BLA-enabling viral clearance study acceptance by global regulatory agencies, form the cornerstones for this pivotal aspect of any CMC development program.
Our experienced regulatory affairs team supports drug filing and registration with over 370 INDs/CTAs, 20+ BLAs/MAAs/NDAs/EUAs, and 150 Module 3 CMC packages since 2015.
Operating multiple high-quality, state-of-the-art clinical-scale cGMP facilities for biologics drug substance (DS) production utilizing both mammalian and microbial expression systems.
Multiple, highly flexible clinical-scale drug product (DP) manufacturing facilities for the formulation, fill, labelling and packaging of biologics and parenterals under Current Good Manufacturing Practice (cGMP) conditions as defined by global regulatory agencies.
We provide a global dual source manufacturing network that employs multiple large-scale drug substance (DS) GMP manufacturing facilities for the production of biologics utilizing our world-class operations and regulatory agency-approved quality systems.
Multiple large-scale drug product (DP) manufacturing facilities located across the globe for the high-quality formulation, fill, labelling and packaging of biologics, parenterals and placebo into a wide array of container closure systems.
High quality, in-house and EMA, ISO (CNAS) and CMA certified biosafety testing facilities for adventitious agent screening of raw materials, cell lines and unprocessed bulk along with our extensive viral clearance capabilities is available to provide our clients with a single-source biosafety testing service offering.
We offer an extensive array of assay development and analytical testing services, including bioassay development and forensic investigation analysis, along with other key characterization and IND and BLA-enabling studies throughout the various phases of drug development – all tailored for your unique product and project needs.
Our CoEs support projects with specialized testing throughout the product lifecycle, expediting project timelines and ensuring analytical readiness for commercialization.
Regulatory compliant, in-house, QC labs support all clinical and commercial GMP sites pre- and post-production, ensuring top-quality testing for products and oversight of other critical functions (e.g., environmental monitoring, cleaning validations, instrument life-cycle and sample/retain management and audits).
Oversees global quality system and audit, IT quality, internal compliance, and risk analytics functions. This team embeds quality and compliance across the entire organization to ensure the products we manufacture are of the highest efficacy and safety standards and in line with your expectations.
Global systems meet regulatory standards, ingrained commitment to quality from CEO to employees, harmonized QA across worldwide sites for biologics and vaccines production.
Our experienced regulatory affairs team supports our client’s CMC dossier, drug filing and registration needs. Since 2015 this team has supported 550+ INDs, CTAs, BLAs, MAAs, NDAs and EUAs, and written 200+ Module 3 CMC packages on behalf of our global clients.
Providing expertise, highly efficient tailored solutions, state-of-the-art technologies and world-class facilities for the engineering, generation, and optimization of antibodies and other biologics from target identification to final lead selection.
Providing industry-leading 10-month (or less) DNA to IND timeline for biologics by leveraging our single-source, high-quality, and well-vetted development platform across all CMC activities.
Streamlined late-phase development and manufacturing services, ensuring BLA filing in 15 months or less, with global commercialization support through our highly-vetted development platforms.
Bispecific & Multispecific Antibodies - WuXiBody
The WuXiBody platform for the generation of bispecific (bsAb) and multispecific (msAb) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of mAb sequence pairs into various formats with different valency.
Advanced Hybridoma Platform - WuXiHybrid
Using advanced technologies to generate diverse monoclonal antibodies (mAb) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality mAbs to our clients worldwide.
VHH-based Multispecific Antibody Platform - SDARBody
Novel technology platform to enable the development of multispecific proteins. Highly flexible platform capable of generating multispecific antibody and protein therapeutics with high affinity, low immunogenicity risk and excellent developability characteristics.
ScFv-based BsAb & MsAb Antibody Platform - SKYBody
An innovative scFv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves scFv stability providing bsAbs and msAbs with strong developability characteristics.
VAST-B Single B-Cell Antibody Discovery Platform
An advanced, high speed, high throughput and high resolution antibody screening strategy using Beacon technology for the rapid discovery of monoclonal antibodies (mAb) from any host species.
Ultra-intensified fed-batch bioprocessing platform
Utilizes an intermittent perfusion approach to achieve 3-6-fold higher productivity and 60 – 80% reduction in manufacturing cost of goods compared to traditional fed-batch processes.
Custom protein generation services, producing high-quality, research-grade proteins/antibodies by using our industry-leading team of cell culture, purification and analytical experts and high-throughput, cost-effective production technologies.
Proven, high-yielding (up to 11 g/L) and high-quality cell line development platform, accepted by regulatory agencies worldwide.
This ultra-high productivity continuous bioprocessing platform achieves 5-15X greater productivity, delivering high-yield, quality drug products with flexibility and cost-effectiveness through intensified perfusion culture, continuous harvest and optional downstream continuous product capture step.
Our drug-to-antibody ratio and enrichment technology greatly enhances DAR4 (four payload molecules per mAb) percentage in the final ADC product and improves conjugation efficiency.
High Concentration & HTP DP Platform - WuXiHigh
Advanced high throughput formulation platform for development of high concentration biologics drug products using distinctive viscosity reducers and synergistic excipient combinations to enhance formulation stability and reduce viscosity.
We operate several of the world’s largest single-use bioreactor facilities for biologics manufacturing, leveraging the risk reduction, flexibility, cost-effectiveness, and eco-friendliness offered by these systems.
Helping to pioneer this biomanufacturing strategy for higher volume production, we can help you reduce risk and increase manufacturing flexibility across the entire product lifecycle by using multiple, same-scale bioreactors to meet clinical and market demand.
Reducing manufacturing risk through the use of this fully programmable, robotic, gloveless, isolator-based technology for advanced aseptic drug product fill processing. These systems provide extensive flexibility to support complex fills across a wide range of biologics and container closure systems.
Combining intensified perfusion culture (IPC) and continuous direct product capture (CDPC), and advanced equipment for increased productivity and cost reduction.
We offer CMC-compliant, one-stop solution for animal health, to support taking drug substance and drug product from research to manufacturing.
As QC Equipment Specialist, you will be responsible for supporting Equipment Introduction and Qualification in the QC Analytical workstream and to deliver tasks on time as per the project schedule.
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, providing 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 Equipment Specialist, 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 Equipment and Systems Team Lead.
Your Responsibilities
* Execute all aspects of QC instrument and equipment validation support throughout the validation lifecycle including URS, RTM, IOQ etc.
* Preparation and review of required validation documentation including protocols and reports.
* Ensure data integrity requirements are included and met as part of the new instrument qualification.
* Establishment of procedures for management and maintenance of the validated system.
* Authoring, review and approval of qualification/validation protocols and reports and status reports.
* Periodic review of instrument qualification packages as required.
* Initiate Change Controls for any new equipment identified as part of the NPI (New Product Introduction) programme and for changes on existing equipment.
* Manage Instrument and equipment validation, calibration and maintenance scheduling.
* Liaise with Vendors, Calibration, EHS, QA and QC to deliver instrument qualification and re-qualification schedules.
* Deliver on equipment Release timelines.
* Support the QC investigation process by providing accurate and concise information in a timely manner and raising investigations, where required.
* Participate in cross functional teams as required to provide support on, and resolution of, QC instrument and equipment validation requirements/issues.
* Partner closely with customers and stakeholders to understand QC instrument and equipment validation requirements and escalate when necessary.
* Proactive engagement with customers and key stakeholders.
* Maintain the QC laboratories in a state of audit readiness at all times.
* Participate in and drive the continuous improvement of all aspects of the group.
* Ensure compliance with cGMP, corporate standards, site policies / procedures, and regulatory requirements.
* Attend tier meetings providing updates on QC Equipment and escalations where applicable.
* Identifying and monitoring key milestones and addressing issues that may impact the critical path of the schedule.
* Manage other QC schedules as required e.g. Equipment PM/PV, periodic reviews, calibrations to ensure there is no impact to the QC Laboratories.
* Support the Continuous Improvement process to eliminate procedural and scheduling inefficiencies.
* Engage and manage stakeholders effectively, resolving issues and understanding drivers/needs. Being aware of potential risks and escalate if necessary.
* Perform all duties in accordance with GMP requirements, SOPs and controlled documents as required.
* Will be flexible to take on additional tasks and responsibilities at the discretion of the QC management team.
* Will act as a role model for the QC function and also the wider organisation in adherence to the WuXi corporate core values.
Your Profile
The ideal candidate for this position, will have the following:
* A strong knowledge and experience of validation or qualification experience with laboratory instrumentation, validation and project lifecycle, ideally within a pharma / biopharma FDA regulated environment.
* Excellent planning and organizational skills, prioritizing abilities and work efficiently.
* Excellent communication and interpersonal skills.
Experience
* 3+ years’ experience working in a fast-paced environment.
* Experience in a GMP facility, in a lead or project manager role is desirable.
* Experience with facility start-up projects (brown field or green field) is desirable.
Knowledge
* Knowledge / experience in the operation of GMP Pharmaceutical Sites would be an advantage.
Qualifications
* Collaborative and inclusive approach to work and your colleagues.
* Excellent problem solving and troubleshooting skills.
* 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.
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.
WuXi Biologics is an equal opportunities employer.
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