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 Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Recombinant Proteins / Enzymes / Cytokines Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type High quality, expert services for biologics produced from microbial fermentation. Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type 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, Wu Xi 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. 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 c GMP 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. 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 Co Es 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. 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). 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 - Wu Xi Body The Wu Xi Body platform for the generation of bispecific (bs Ab) and multispecific (ms Ab) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of m Ab sequence pairs into various formats with different valency. Advanced Hybridoma Platform - Wu Xi Hybrid Using advanced technologies to generate diverse monoclonal antibodies (m Ab) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality m Abs to our clients worldwide. Offering high-quality phage display library construction and customized library selection and screening services via our Wu Xi Li Ab human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries. 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. Sc Fv-based Bs Ab & Ms Ab Antibody Platform - SKYBody An innovative sc Fv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves sc Fv stability providing bs Abs and ms Abs 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 (m Ab) 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 5-15 X 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 m Ab) percentage in the final ADC product and improves conjugation efficiency. High Concentration & HTP DP Platform - Wu Xi High 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. 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 Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Recombinant Proteins / Enzymes / Cytokines Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type High quality, expert services for biologics produced from microbial fermentation. Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type Discover information about the various drug development services we provide for this product type 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, Wu Xi 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. 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 c GMP 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. 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 Co Es 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. 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). 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 - Wu Xi Body The Wu Xi Body platform for the generation of bispecific (bs Ab) and multispecific (ms Ab) antibodies speeds up drug development by 6-18 months, cuts production costs, and enables flexible assembly of m Ab sequence pairs into various formats with different valency. Advanced Hybridoma Platform - Wu Xi Hybrid Using advanced technologies to generate diverse monoclonal antibodies (m Ab) for various targets. Our experienced scientists overcome technical challenges to deliver high-quality m Abs to our clients worldwide. Offering high-quality phage display library construction and customized library selection and screening services via our Wu Xi Li Ab human naïve / synthetic phage display libraries, VHH naïve / humanized VHH synthetic libraries and antibody immune libraries. 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. Sc Fv-based Bs Ab & Ms Ab Antibody Platform - SKYBody An innovative sc Fv (single-chain fragment variables)-based platform for the generation of bispecific or multispecific antibodies from nearly any sequence pair. The platform significantly improves sc Fv stability providing bs Abs and ms Abs 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 (m Ab) 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 5-15 X 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 m Ab) percentage in the final ADC product and improves conjugation efficiency. High Concentration & HTP DP Platform - Wu Xi High 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. As Director of Business Development, Wu Xi Vaccines, you have the unique opportunity to join the Wu Xi Business Development team across Europe, to focus on our service offering for Wu Xi Vaccines as we rapidly increase our customer base in Europe. As we continue to support and enable new and existing customers, we are seeking to add to our business development team. This role is responsible for providing strong cross functional leadership within the European sales territory, while continuing to grow the business across existing and new accounts. Working closely with the Wu Xi leadership team and operations to develop the right strategies and tactics to meet the annual revenue targets for the region. To be able to stay current on competitors and competitive strategies and provide input needed for the development of future services and products. This position can be based anywhere in Europe, but preferably in UK. Reports into Snr Director, Global Business Development and Alliance Management Responsibilities  Achieve European regional sales target for Wu Xi Vaccines projects  in the European region. Grow revenue through cross selling into exiting accounts, managing the portfolio of customers and generating new business. Plan and perform the selling, proposal and contract negotiation process independently. Build strong internal relationships across functions Represents Wu Xi Biologics and Wu Xi Vaccines at key trade shows Contributes to key commercial strategies across the sales team Responsible for managing all aspects of the customer relationship. Timely update of CRM and monitoring of KPIs Qualifications At least 5+ years of life science experience in the vaccine industry or related area. At least 5-10 years of successful sales and territory management experience within the CMO / CRO vaccine market segment. Strong written and oral communication skills. Strong gravitas and relationship building skills Listening and empathy demonstrated Demonstrated ability to work under pressure. Demonstrated success at managing multiple opportunities and projects simultaneously. Ability to work effectively as part of a team in direct reports and cross functional capabilities and to exhibit effective interpersonal skills. Ability to develop and implement sales strategies and tactics Must be organized and detailed-oriented. Good command of English, written or verbal. Ability to accomplish the described duties with the use of appropriate computer equipment and software (especially Microsoft Word, Excel, Outlook, Power Point and CRM tool). Valid Passport and the ability to travel 50% of the time .
#J-18808-Ljbffr