Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Responsible for the support activities and disinfection of GMP space, equipment and associated areas involved in the manufacture of Master and Working Cell Banks, within production facilities involved in the manufacture Cell & Gene Therapy products and final product fills according to current Good Manufacturing Practices (cGMPs).

Leads the business development activities to find and cultivate client business opportunities that result in increasing revenue for WuXi Advanced Therapies (ATU) in the area of Biologics, Cell and Gene Therapy (CGT) Biosafety and Characterization Testing.

This position will oversee sales operations specialists and as team, work closely with sales, finance, operations, legal and marketing to improve the effectiveness and efficiency of the processes and deliverables used to propose and win business

Job Summary: Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents.  This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).  

The Training Associate II will have the responsibility for performing a variety of tasks related to learning and development in a Good Manufacturing Practices (GMPs) facility. The position requires providing classroom and laboratory training to site employees who produce and/or support Master and Working Cell Banks. The ideal candidate will have strong communication and leadership skills. The individual must be able to coach and mentor trainees and elevate issues to proper personnel timely.  

The Training Associate II will have the responsibility for performing a variety of tasks related to learning and development in a Good Manufacturing Practices (GMPs) facility. The position requires providing classroom and laboratory training to site employees who produce and/or support Master and Working Cell Banks. The ideal candidate will have strong communication and leadership skills. The individual must be able to coach and mentor trainees and elevate issues to proper personnel timely.   Please note the work schedule:  Monday - Friday 8:00am - 5:00pm (core business hours)

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role: Sunday - Tuesday with alternating Wednesday 7:00am - 7:30pm

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role: Monday - Friday 8:00am - 5:00pm (core business hours)

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role: Thursday - Saturday with alternating Wednesday from 7:00am - 7:30pm

Job Summary: Responsible for generating and/or review manufacturing related technical documents and manage timely closure of these documents.  This includes but is not limited to Non-Conforming Event (NCE) investigations, CAPAs, Change Controls (CC), Batch Records (BR), Technical Transfers (TT), Final Reports (FR), and Standard Operating Procedures (SOP).  

Performs any basic to complex Analytical and microbiological assay(s) according to and in compliance with Good Laboratory Practices (GLP), current Good Manufacturing Practices (cGMP), Code of Federal Regulations (CFR) and/or Points to Consider (PTC) guidelines and Standard Operating Procedures (SOPs). Completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs daily work activities with minimal supervision.  Sufficiently competent in science to initiate and carry out scientific development projects related to the development of new assays, initiation of new programs, assay validations and associated...

This position is required to work on shift and be on-site. A Specialist role to provide Quality oversight in manufacturing operations at the site and monitor processes for adherence to established procedures/regulatory compliance. High level job accountabilities included activities related to sterility assurance, manufacturing oversight, quality system and release of raw materials. Anticipated hours: 2:00PM - 12:30 AM

The Associate Quality Assurance Specialist Testing reviews Testing batch records in accordance with current Good Manufacturing Practices (cGMP).  Monitors processes for adherence to established procedures/regulatory compliance.  Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner. 

Primary Quality Assurance Representative for review of GLP Final Reports, GMP Certificates of Analysis (CoA’s), Assay Validations, deviations, and CAPAs. Reviews laboratory testing data or manufacturing batch records in accordance with current Good Manufacturing Practices (cGMP consults with QA Management to resolve complex quality issues in a timely manner.

Manages the QC Flow Cytometry operations and staff.  Demonstrates mastery of flow cytometry theory and practice on multiple platforms.  Experienced Manager that demonstrates leadership in a fast-paced industry setting and operates with minimal oversight and has a clear understanding of business and GMP regulatory demands.   Exhibits rigorous scientific and supervisory skills, a strong practical knowledge of...

Responsible for duties associated with two or more Quality System processes, including: the administration, reporting and process creation / optimization / automation, while ensuring accordance with current good Manufacturing Practices (cGMP), current Good Laboratory Practices (cGLP) and current Good Tissue Practices (cGTP). The processes comprising the Quality Systems include: Non- conformance / Investigations, CAPA, Change Control, Customer Audits, Supplier Audits, Training, and Supplier Qualification Program. Duties include effectively interacting with Testing, Manufacturing, Project Management and Quality Assurance personnel in order to deliver...

Responsible for directing all facilities functions to ensure operational business units are supplied with necessary physical property to meet company objectives including facility operation, maintenance and engineering. Specific responsibilities include preventative maintenance of facilities/systems, monitoring, coordination with metrology and validation, managing facilities change controls, troubleshooting equipment processes, supporting up-to-dates to as-built engineering drawings and Validation Master Plans, managing external contractors, writing reports and staffing and supervising a Facilities group competent in current Good Manufacturing Practices (cGMP) and cleanroom behavior. Interacts with internal departments as well as withbmaterial/equipment...

Primary resource for the development, execution, review, and approval of Computerized Systems Validation, System Life Cycle Documentation (Validation Plans, Design Specifications, Requirements Specifications, etc.), Change Controls, Decommissioning Reports, etc., in accordance with 21 CFR Part 11 and GAMP5. Provides guidance for equipment/software related issues and consults with Equipment Owners, IT and QA Management to resolve complex quality issues in a timely manner.

Responsible for providing direct oversight and leadership in the manufacture of Master and Working Cell Banks and performing activities within production facilities to support manufacture of Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs).   Please note the shift and schedule for this role:  Sunday - Tuesday with alternating Wednesday: 2:00pm - 2:30am