Associate Director, Warehouse

WuXi Biologics Group; Robbinsville Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

WuXi Biologics is seeking an Associate Director for Warehouse Operations in Robbinsville, NJ. The successful candidate will lead warehouse operations, ensuring compliance with cGMP standards while managing inventory and training staff. This role is critical for supporting biologics products and requires extensive experience in warehouse logistics.

Qualifications

• Minimum 7 years’ cGMP warehouse operations experience.
• Supervisory experience required.
• Strong understanding of cGMPs.

Responsibilities

• Manage cGMP and non-cGMP receiving activities.
• Oversee daily warehouse operations and staff.
• Ensure compliance with SOPs and conduct training.

Skills

Communication

Organization

Problem Solving

Tools

SAP Inventory Management

Excel

PowerPoint

MS Project

Word

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.

Job Title - Associate Director, Warehouse

Work Location - Robbinsville NJ

Company Overview:
WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, 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. Our company history and achievements demonstrate our commitment to providing a truly ONE-stop service offering and strong value proposition to our global clients. As of December 31, 2018, there were a total of 205 integrated projects, including 97 projects in pre-clinical development stage, 94 projects in early-phase (phase I and II) clinical development, 13 projects in late-phase (phase III) development and 1 project in commercial manufacturing. With total estimated capacity of biopharmaceutical production planned in China, Ireland, Singapore and US reaching 280,000 liters by 2022, we will provide our bio-manufacturing partners with a robust and premier-quality global supply chain network. The successful candidate will be responsible for conducting experiments to support client-based processes with a focus on vaccine upstream cell culture processes.

Job Summary
This is a full time position, reporting to the Associate Director, Manufacturing Support. The Warehouse Operations Manager will be a key member of the Manufacturing Support team and will work independently and in a team to management receipt and inventory of raw materials, consumables, cell banks, drug substance, etc. in a cGMP compliant warehouse. Responsible for providing direct oversight, coaching, mentoring and leadership in warehouse operations for the support of biologics products according to current Good Manufacturing Practices (cGMPs).

Responsibilites

• Understands, oversees, trains, coaches, mentors and manages performance of others on daily warehouse operations funcitons.
• Manage cGMP and non-cGMP receiving activities for raw materials, consumables, cell banks, equipment, etc. as per company SOP’s.
• Manage cGMP and non-cGMP inventory management for raw materials, consumables, cell banks, etc. as per company SOP’s utilizing an electronic inventory system.
• Manage the transfer of raw materials, consumables, etc. between on-site and off-site warehouse locations.
• Maintain the material warehouse and receiving dock in an inspection-ready state.
• Develop, review and approve SOPs regarding warehouse and inventory management.
• Completion of change control documentation and deviation investigation.
• Act as SME on all applicable equipment and procedures, participating in audits/inspections as needed.
• Identifies process and method gaps and opportunities and implements improvements across assigned programs and site specific
• Communicates with internal and external stakeholders
• Identifies, communicates, addresses and improves complex cGMP compliance and regulatory gaps and issues, champions continuous improvement ideas
• Responsible for ensuring employees are trained on SOPs, equipment, all unit operations and systems
• Accountable for schedule execution, adjustments and performance of work assignments for team to ensure adequate staffing across assigned activities
• Regularly interacts with and supports cross-functional teams.
• Develops, coordinates, and follows organizational systems, policies, procedures, and follows labor and capacity standards
• May be required to work Shifts, Holidays and weekends
• Other duties as assigned

Qualifications

• Minimum 7 years’ cGMP warehouse operations, logistics or supply chain experience.
• Supervisory and/or personnel management experience.
• Experience with ERP inventory management system.
• Strong understanding of cGMPs as applicable to warehousing and inventory management
• Strong communication and presentation skills.
• Excellent organization skills with ability to manage own work.
• This position may require driving a company vehicle; therefore, the incumbent must successfully complete a motor vehicle history check, possess and maintain a current, valid driver's license in their state of residence.
• Strong technical knowledge with demonstration of robust problem solving and continuous improvement.
• Must be able to work with a variety of teams, made up of both technical and non-technical personnel.
• 10+ years of combined experience in cGMP warehousing and/or logistics.
• Experience in SAP Inventory Management (IM) & Warehouse Management (WM).
• Demonstrated Lean / Six Sigma knowledge
• An ability to work through peers and across organizational boundaries and influence at all levels in the business.
• Ability to efficiently use current computer packages in particular Excel, PowerPoint, MS Project and Word.
• Experience coordinating cGMP and non-cGMP material and goods shipments including importing to and exporting from the United States.

Physical Requirements

• Must be able to work in an office environment with minimal noise conditions.
• Must be able to work in Lab setting with Biohazards / Various Chemicals
• Must be able to wear appropriate PPE
• Must be able to work in environment with variable noise levels
• Ability to Stand / Sit / Walk for long periods of time
• Ability to Lift / Push / Pull 50 lbs routinely
• Ability to crouch, bend, twist, and reach
• Clarity of vision and have the ability to identify and distinguish colors
• Must be able to perform activities with repetitive motions
• Ability to climb Ladders / Stairs / Scaffolding
• Ability to work in variable temperatures from high to freezing
• Ability to work in indoor and outdoor working conditions

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.
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