Associate Scientist, Quality Control Environmental Monitoring

WuXi Biologics Group; Cranbury Township (NJ); On-site; USD 50,000 - 75,000; Full time

Job summary

A leading biotech company in Cranbury, NJ is seeking an Associate Scientist for Quality Control Environmental Monitoring. The role involves ensuring compliance with GMP regulations, performing environmental sampling, and supporting laboratory operations within a dynamic team. Ideal candidates should possess a background in Chemistry or related fields and a willingness to learn in a regulatory environment.

Qualifications

• Willingness to learn about QC operations and regulations.
• Experience in planning and solving technical problems.
• Proficiency in English with strong communication skills.

Responsibilities

• Ensure compliance with GMP sampling and testing.
• Perform environmental sampling in cleanroom areas.
• Manage QC documentation and report results independently.

Skills

Problem Solving

Clear Communication

Analytical Skills

Education

High school certificate or above degree in Chemistry, Microbiology, Biochemistry

Advanced Graduate degree

Tools

Analytical Instruments

Software (e.g. Empower, TrackWise)

Job description

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

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, 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

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

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, 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 Scientist, Quality Control Environmental Monitoring

Share

Associate Scientist, Quality Control Environmental Monitoring

United States Posted 2025-05-16

Job Title – Associate Scientist, Quality Control Environmental Monitoring

Work Location – Cranbury NJ

Job Summary

The QC EM Associate scientist/scientist is responsible for the quality and on-time collection of samples, EM (Environmental sampling), Water and Gas system sampling (when required) with raw material sampling to the various testing sections. This role will also ensure QC deliverables to internal departments and external clients are accurate and consistent. Demonstrates strong oral and written communication skills and actively contributes to training, report generation and GMP documentation.

II. Job Functions

· Adhere to GMP sampling (Clean rooms, WFI, gas) and testing, follow laboratory procedures according to and in compliance with cGMP guidelines and internal SOPs.

· Able to follow and conduct EM sampling in cleanroom areas in/between the various building sites in Cranbury or other US sites (when needed).

· Able to support sample transporting needs in/between the various building sites in Cranbury or other US sites (when needed).

· Perform micro related testing including but not limit to bioburden, pH, growth promotion, endotoxin, conductivity, TOC, nitrate, plate readings, plate transferring etc (when required).

· Receive required samples, perform testing, report results independently and in a timely manner (when required).

· Able to input data and generate EM data trend charts.

· Able to initiate investigation/excursions when having OOS/OOL/Atypical results.

· Support reagents/consumables inventory management to ensure consistent QC Microoperation needs.

Operate according to the experimental or sampling plan and deliver results, testing/sampling method/SOP's

· Record and organize experimental data in accordance with "Good Document Management Practices" to ensure data integrity.

· Ensure compliance to training, preparation, documentation and general lab maintenance requirements for Industry Standards and/or Regulations.

· Assist in preparing SOP, protocols, final reports, investigations, and deviations as needed.

· Assist in investigating any Out-of-Specification results and laboratory deviations, conducting root cause analysis, and implementing CAPA.

· Assist in preparing or executing validation documents to support new materials, process changes and qualifications.

· Maintains laboratory notebooks and worksheets for QC tasks as required.

· Able to work at weekend when needed (up to 10% of the time).

· Support shift work when required by supervisor (when needed)

· Any other duties assigned by the supervisor (when applicable).

III. Qualifications

Technical Skills / Knowledge:

• Candidate must possess willingness to learn analytical and QC operations of pharmaceutical industry, understand current regulations and industry trends of biologics product development, characterization and manufacturing testing requirement including cGMP, ICH, EMA, FDA, and other global compendia regulations and guidance.
• Basic familiarity with analytical instruments and methodologies, such as TOC, conductivity meter is preferred but not mandatory.
• Basic experience with software and information systems (e.g. Empower, TrackWise, Master Control, LES, lab notebook and preferably LIMS). Ability to adapt between strategic and tactical thinking/planning and manage multiple priorities to achieve department and site objectives.
• Ability to understand technical data

Problem Solving:

• Basic experience in planning and ability to solve simple QC technical and operation problems.
• Be able to raise issues immediately to supervisor and work with supervisor when in doubt.

Communication Skills:

• Proficiency in English is required. Good communications skills (verbal, written, and presentation skills).
• Effectively exchange information or discuss clearly framed issues or ideas with colleagues.

Education and Experience:

• High school certificate or above degree and/or advanced Graduate degree in Chemistry, Microbiology, Biochemistry or equivalent field.
• High school certificate: <1 year and above working experience is preferred
• Bachelor's degree: <1 year and above working experience is preferred

The job description does not intend to list all the duties and responsibilities assigned to this position. Employee holding this position would be required to perform other job-related duties/responsibilities based on their expertise and company business needs.