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The Operations Supervisor is responsible for ensuring operational activities are carried out in compliance with GMP regulations, hygiene rules, and safety standards. They must ensure adherence to the established production plan while following procedures defined by the pharmaceutical site’s quality system. They will also be responsible for supervising operators and technicians during operational steps. The Operations Supervisor manages and plans GMP cleaning of production areas.
This position is a leadership role, being responsible for the direct management of people managers & individual contributors. As a key leader, you are jointly responsible for the site culture by leading by example and role modeling WuXi values and competencies.
Job Summary: Lead the material supply processes related to products manufactured at the Middletown site, from the procurement of the raw materials to the shipment of finished goods, as well as manufacturing master data management.
The Portfolio Manager plays a pivotal role in managing key accounts, fostering client relationships, and coordinating program workflows to drive the growth and expansion of our comprehensive drug discovery services. Responsible for the strategic oversight and management of the assigned portfolio of projects and programs. This role involves selecting, prioritizing and optimizing initiatives to align with the business goals, maximize return on investment (ROI) and manage risks. The Portfolio Manager collaborates with senior leadership, program managers, and project teams to ensure efficient resource allocation and delivery of strategic outcomes. They play a critical role in...
HD Biosciences Inc., a WuXi AppTec company, offers biology-focused preclinical drug discovery services to biotech and pharmaceuticals. We offer our clients comprehensive service platforms around target validation, plate-based pharmacology, hit identification and lead discovery, in vivo pharmacology, as well as other research and development services.
We are seeking a highly motivated and skilled scientist to support our neuroscience platforms to find cures for the neurodegenerative and neuroinflammatory diseases. The successful candidate will be responsible for developing and executing advanced vitro assays using human iPSC-derived neuronal cells, primary neuronal cells, co-culture systems, and other cellular models to support drug...
We are seeking a skilled and experienced Utilities Superintendent to oversee the operation, maintenance, and reliability of all utilities, facilities, and grounds for our pharmaceutical manufacturing facility in Middletown DE. This role is responsible for ensuring all utilities equipment, automation & controls, and facilities are operated efficiently, safely, and maintained in compliance with Good Engineering Practices. The ideal candidate will lead a team of multi-skilled operators and maintenance technicians, manage vendor service contracts, and implement preventive/predictive maintenance programs, while working closely with cross-functional teams to...
This role will design, develop, optimize, and support GMP drug product manufacturing and packaging process, including equipment, facilities, and control systems at our Middletown, Delaware site. This may include support of CQV programs for manufacturing/packaging equipment, instruments, utilities, and processes. The Engineer is also responsible for ensuring external and internal quality standards are applied and followed.
The Quality Specialist will play a pivotal role in implementing and maintaining the Quality Management Systems (QMS) at our new manufacturing facility. This position involves ensuring operational readiness through inspections, conducting internal audits, and managing regulatory and client audits. The role also encompasses follow-up on audit findings via Corrective and Preventive Actions (CAPA), with potential support in training, batch record review, and product disposition. The ideal candidate is a detail-oriented professional with a strong background in pharmaceutical quality assurance, capable of thriving in a fast-paced, startup-like environment while adhering to GMP (Good Manufacturing...
The Senior Cost Accountant will be responsible for managing, analyzing, and reporting cost information to support decision-making within our pharmaceutical manufacturing operations. This role will focus on standard costing, cost variance analysis, inventory valuation, capex/fixed asset maintenance, and financial reporting to ensure compliance with company policies, regulatory standards, and industry’s best practices. The individual will work closely with operations, supply chain, and finance teams to optimize cost structures and drive continuous improvement in cost control processes.
Process R&D Scientist (San Diego, CA) – Research and develop safe and efficient chemical processes to produce SM (starting materials), intermediates, and APIs using Process R&D, Chromatographic/Analytical techniques, Safety Consciousness; Test and evaluate chemical reactivity hazards using reaction calorimetry, and batch process modeling tools using Experimental design and planning; Plan, execute, and document cGMP and non-GMP/GLP laboratory work supporting regulatory submissions; Assist with Scale up (multi-kg scale) tech transfers from Kilo Lab and Pilot Plant scales following cGMP compliant execution of API manufacturing processes; Research and recommend new methods and alternative synthetic sequence techniques to optimize existing processes...
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its In Vitro Immunology team. We’re seeking a highly skilled and motivated Research Associate II to support our team for cell line generation, and cell-based assays for various projects.
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its Target Discovery team. We’re seeking a highly skilled and motivated Research Associate II to support our team for cell line generation, and cell-based assays for various projects.
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its In Vitro Immunology team. We’re seeking a highly skilled and motivated Research Associate II to support our team for cell line generation, and cell-based assays for various projects.
The Business Development Manager drives sales growth of assigned region in close coordination with WuXi Biology leadership. The Business Development Manager will have an additional focus on penetrating certain assigned customers with significant growth opportunity, as assigned by management. The incumbent of this role will close and implement growth opportunities with Companies in the assigned territory. The Manager, Business Development’s most important means of interacting with customers and prospects is through face-to-face meetings and is responsible for achieving an assigned sales and profit goal.
We are seeking a skilled and experienced Equipment & Controls Maintenance Manager to oversee the maintenance, repair, and reliability of base building and manufacturing equipment in our pharmaceutical manufacturing facility. This role is responsible for ensuring all equipment, automation & controls, utilities, and facilities are operated efficiently, safely, and maintained in compliance with Good Manufacturing Practices (GMP), FDA, and other regulatory standards. The ideal candidate will lead a team of multi-skilled maintenance technicians and engineers, implement preventive/predictive maintenance programs, while working closely with cross-functional teams to support production goals and continuous improvement initiatives.
HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology team. We’re seeking a highly skilled and motivated Senior Scientist to lead/support our in vivo pharmacology team for various projects.
We are seeking a highly experienced and detail-oriented CQV (Commissioning, Qualification, and Validation) Manager to lead the execution of commissioning qualification, and validation activities at our pharmaceutical manufacturing facility. The CQV Manager is responsible for ensuring all equipment, computerized systems, facilities, and processes meet regulatory and quality standards (FDA, EMA, ICH) and are in a state of control throughout their lifecycle. The ideal candidate will manage cross-functional teams, interface with contractors and engineering teams, and drive compliant, efficient validation programs across both new and existing...
Provides support for shipping and receiving activities, R&D and GMP inventory control, and general warehouse operations. Assists with inventory stocking and ensures building supplies are properly maintained. Experienced in material handling and inventory management practices. Helps maintain accurate records, including material requests, inventory logs, and import/export documentation. Supports the safe shipment of hazardous materials in compliance with regulatory guidelines. Works effectively both independently and as part of a team, following established procedures and applying relevant technical skills.
This position you will be responsible for effective provisioning, installation/configuration, operation and maintenance of systems hardware/software and related infrastructure. Act as Tier I and II support to end users on a daily basis when required. Responsible for first level day to day onsite support of users and systems (regulated and non-regulated). Ensure hardware, operating systems, software, and related procedures adhere to organization values.
WuXi AppTec Pathologists contribute to a wide range of critical activities within Toxicology, Safety, and Biocompatibility. Testing including but not limited to study evaluation for nonclinical studies spanning all phases of drug development for pharmaceutical industries.
Ce poste est un rôle de leadership étant responsable de la gestion des superviseurs et/ou des équipes de production.
Ce poste est une garantie et un modèle pour les valeurs et les compétences de WuXi.
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