Associate Director Downstream Process Development

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

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

We offer customized antibody discovery platforms for monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), multispecific antibodies (msAbs), immunocytokines, and other therapeutic modalities, to accelerate biology-driven lead identification.

At WuXi Biologics, we specialize in the production and engineering of monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and novel biologics. With industry-leading expertise, state-of-the-art facilities and proprietary technologies, we offer our customers high-quality protein engineering and production services for research use.

At WuXi Biologics, we provide comprehensive protein characterization testing to help you triage and optimize your lead candidates. Our integrated protein characterization and analytics platform includes purity/impurity testing, structure characterization assessment, including MS-based protein ID and post-translational modification analysis, and function testing (e.g., SPR/ELISA/cell-based activity assays).

Leveraging advanced in vitro assay technologies such as cellular, biochemical, molecular, immune, and Fc effector function assays, we deliver reproducible, high-quality results with data interpretation to support biologics discovery and development.

Our multi-species in vivo pharmacology services provide science-driven solutions for preclinical studies, including pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, efficacy models, toxicology studies, and immunohistology.

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.

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.

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 - 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.

Offering high-quality phage display library construction and customized library selection and screening services via ourWuXiLiAbhuman 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.

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.

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

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

We offer customized antibody discovery platforms for monoclonal antibodies (mAbs), bispecific antibodies (bsAbs), multispecific antibodies (msAbs), immunocytokines, and other therapeutic modalities, to accelerate biology-driven lead identification.

At WuXi Biologics, we specialize in the production and engineering of monoclonal, bispecific, and multi-specific antibodies, fusion-proteins, cytokines, enzymes, and novel biologics. With industry-leading expertise, state-of-the-art facilities and proprietary technologies, we offer our customers high-quality protein engineering and production services for research use.

At WuXi Biologics, we provide comprehensive protein characterization testing to help you triage and optimize your lead candidates. Our integrated protein characterization and analytics platform includes purity/impurity testing, structure characterization assessment, including MS-based protein ID and post-translational modification analysis, and function testing (e.g., SPR/ELISA/cell-based activity assays).

Leveraging advanced in vitro assay technologies such as cellular, biochemical, molecular, immune, and Fc effector function assays, we deliver reproducible, high-quality results with data interpretation to support biologics discovery and development.

Our multi-species in vivo pharmacology services provide science-driven solutions for preclinical studies, including pharmacokinetic (PK) and pharmacodynamic (PD) evaluations, efficacy models, toxicology studies, and immunohistology.

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.

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.

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 - 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.

Offering high-quality phage display library construction and customized library selection and screening services via ourWuXiLiAbhuman 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.

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.

Associate Director Downstream Process Development

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Associate Director Downstream Process Development

United States Posted

Job Title: Associate Director, Downstream Process Development

WuXi Biologics is a is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. WuXi Biologics’ achievements are a direct result of the efforts made by our employees.

Job Summary:

Lead and manage a team responsible for downstream process development, optimization, process scale-up to non-GMP scales, and technology transfer to cGMP manufacturing. Define and execute the strategic direction of the department. Identify, evaluate, and execute process improvements to enhance existing capabilities. Balance stakeholders and interact closely with clients, Manufacturing and CMC teams to ensure timelines and expectations are met. Provide scientific and business consultation to the site and executive leadership team.

Responsibilities:

• Oversee the development of scalable processes for optimal expression, purification, and quality attributes of antibodies, recombinant proteins, and other biomolecules.
• Collaborate with Manufacturing Sciences and Technology (MSAT) group to ensure seamless transfer of processes from PD into manufacturing for early-phase through commercial manufacturing activities . Designs, executes, and authors downstream purification development, optimization, scale up and tech transfer.
• Responsible for bench scale purification process development, optimization, and process transfer studies.
• Designs and executes pilot-scale experiments to support non-GMP material generation.
• Manages project workflow to ensure on timely delivery: from initial planning, experiment execution, to data evaluation.
• Supervises or p erforms independent data analysis, interpretation, and develops strategies for optimization and troubleshooting.
• Authors study protocols and reports, and ensures all data are reported clearly and accurately ; Serves as trainer for inter - and intra - departmental staff as needed.
• Leads tech transfer to GMP manufacturing and supports deviations and investigations.
• Serves as Downstream purification SMEs to p articipates in client calls and face to face meetings. Provides project plans and updates to clients.
• Coach junior and senior scientists and staff on process development and design of experiments.
• Authors Downstream lab equipment SOPs; maintains equipment functionality and coordinates repairs and preventative maintenance.
• Performs job specific tasks in compliance with applicable Regulations, International Standards, and WuXi Biologics internal policies and guidelines.
• Completes all required training (i.e. safety, equipment etc.).
• Contributes to the overall operations and to the achievement of departmental goals.
• May be required to assist in other departments or assigned other duties.

Qualifications:

• Ph . D . in Life Sciences or related field with 8 + years, or Master Degree with 12 + years of experience in a biopharmaceutical or biological contract testing/manufacturing organization.
• Expertise , strong technical knowledge and hands-on experience in downstream purification process development and lab scale and pilot scale experimental execution, including chromatography, UFDF, viral inactivation, depth filtration, and viral filtration, etc. , for biomolecules such as mAbs and recombinant proteins.
• Experience with early-stage and late-stage CMC of different biologics modalities.
• Experience in project management, Quality by Design concepts, late-stage process development/tech transfer, control strategy is highly desirable.
• Significant experience in leading and managing a team of bioprocess development scientists or engineers, demonstrating direct involvement in developing programs from early stages through licensure.
• Proven experience in process characterization using Design of Experiments (DOEs) and Quality by Design (QbD) concepts.
• Demonstrated ability to proactively identify and implement novel technologies.
• Proven track record of scientific publications and conference presentations.
• Strong collaboration and leadership skills to drive continuous improvement and promote knowledge sharing and implementation of best practices.
• Experience in a cGMP environment is highly desirable.
• Ability to take on multiple tasks simultaneously is required .
• Proficient in Microsoft (Excel, Word, Outlook)

Physical Requirements:

• Must be able to work in Lab setting with Biohazards/various Chemicals

• Must be able to wear appropriate PPEs

• Ability to Lift 40 lbs

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability

The anticipated pay range for this position is $112,000-$190,000