Scientists (San Diego, CA) – Develop and modify efficient and safe scalable processes for producing pharmaceutical starting materials, intermediates, and APIs; Apply pharmaceutical process (dissolution, mixing and crystallization, etc.), pharmaceutical industrial engineering knowledge (pharmaceutical design, development, manufacturing, and regulatory requirements) to optimize technical transfer from lab-scale to kilo lab/pilot plant production; Implement hazard operability analysis and risk assessment skills to draft batch records and safety reports; Analyze lab and production data using NMR instrumentation, data interpretation, Chromatography to ensure FDA regulatory compliance and maintain quality standards.    

The Human Resources Information Systems (HRIS) & Data Analyst provides technical and analytical support to the Human Resources department in pursuit of HRIS initiatives and other HRIS-related responsibilities. This includes but is not limited to maintaining quality and consistency of HRIS database information; ensuring personnel actions are following current Human Resources policies and guidelines; providing HRIS technical support to Human Resources and other staff; serving as liaison to other functional areas such as Benefits, Human Resources, Recruiting, Payroll and Finance.  Supports methods to measure effectiveness of people programs, uncover insights and opportunities; and build capacity within the People organization to utilize data and analytics to drive decision-making.   This is a mostly remote position, working in-person one day per week at either the Cranbury, NJ or Philadelphia Navy Yard facility.  

WuXi TIDES, a leading Contract Research and Development Manufacturing Organization (CRDMO), is an integral part of the WuXi AppTec’s subsidiary WuXi STA. WuXi TIDES offers our worldwide partners efficient, flexible, and high-quality solutions for the drug development of oligonucleotides, peptides and related synthetic conjugates (“TIDES” drug). We greatly simplify the TIDES drug development by providing all discovery, CMC development and the entire manufacturing supply chain under one roof.   With over 1,000 scientists from 9 R&D and manufacturing sites, we offer discovery compound screening and synthesis, process development and manufacturing of novel monomers, linkers and ligands, oligonucleotides, peptides and complex synthetic conjugates at any scale. Beyond chemistry, we offer formulation development, drug product manufacturing, labeling and distribution services in a variety of injectable dosage forms and filling formats including the Lipid Nanoparticle (LNP) drug delivery platform. Our comprehensive analytical method development, validation and testing platform will support your needs in TIDES drug development from discovery through clinical to commercial. Moreover, our Regulatory Affairs CMC team is experienced in preparing CMC dossiers to support global filings for TIDES new drug applications.     Job Summary:  The incumbent will uncover and cultivate business relationships and opportunities to generate revenue with prospective and existing clients for STA Pharmaceutical, a WuXi AppTec company, in particular to support the growth of emerging Discovery oligonucleotide and peptide (O&P) Contract Development and Manufacture (CDMO) business. The candidate will work closely together with the U.S business development (BD) teams to pursue new business leads; follows up on critical issues and aides in resolving customer inquiries. Assists marketing in delivering content and driving success of new and existing services. This position will report to the Director of Business Development, Oligo/Peptide and will help to support Discovery O&P BD efforts.

This position is responsible for all aspects of receiving and internal deliveries to end users.

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Manufacturing Associate I is responsible for 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).

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Manufacturing Associate I is responsible for 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).

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Manufacturing Associate I is responsible for 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).

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Manufacturing Associate I is responsible for 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).

The Senior Manager, Business Development for the EU recruits customers, and drives sales growth of products and services. The Senior Manager, Business Development will have an additional focus on penetrating certain assigned customers with significant growth opportunity, as assigned by management. Reporting to the Executive Director of Business Development, the BD closes and implements growth opportunities with Companies in Scandinavia and other territories if assigned. The BD’s most important means of interacting with customers and prospects is through face-to-face meetings. The BD is responsible for achieving an assigned sales and profit goal. 

Execute Business Development plans in close coordination with Research Chemistry Service (RCS) leadership leading to identification, penetration and growth of business and accounts in UK/Ireland region. The (Senior) Director Business Development UK drives sales growth in close coordination with Research Chemistry Services leadership penetrating certain assigned customers with significant growth opportunity, as assigned by management. Reporting to the Executive Director, Business Development, the (Senior) Director Business Development closes and implements growth opportunities with Companies in the UK/Ireland by interacting with customers and prospects is through face-to-face meetings and is responsible for achieving an assigned sales and profit goal. The (Senior) Director Business Development will also manage other RCS BD in the UK/Ireland territory to ensure close alignment of activities to drive new business growth. Remote management of Scandinavia BD also possible.

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Manufacturing Associate I is responsible for 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).

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need. Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning. Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Bioprocessing Associate I is responsible for providing support in performance of activities within production facilities to support manufacture of Master and Working Cell Banks Cell & Gene Therapy products, and final product fills according to current Good Manufacturing Practices (cGMPs). 

The Engineer, Manufacturing is involved in the new product introduction of oral solid dosage forms (capsules and tablets) in the site of Couvet. He/she is involved in all the technical activities related to manufacturing. He/she authors, owns and leads updates of GMP documents related to new product introduction for Bulk and/or Packaging Operations. He/she trains the operational teams to the protocol/master batch record for the new product.

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more Performs Cell Culture and Cell-Based assays (BSL2 and BSL2+) 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 batch records 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.

QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products. This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required and maintaining working relationships with QA departments at contract facilities. The position will support on the floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints …) Couvet site included work in 2*8 shift if required. As a member of Quality Operations team, this position will be expected to be reliable source of information and interpretation of quality and cGMP compliance requirements. Furthermore, the position holder is responsible to identify and handle packaging, warehouse, or bulk/QC and cGMP compliance related issues. Additional tasks are quality metrics, risk assessments, as well as the support of health authorities’ inspections and corporate audits. This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished/semi-finished product, bulk product, or raw materials for production, as well as to contribute to process improvement in his/her scope of activity.

This position is accountable for all New Product Introductions at the site of Couvet, Switzerland. This includes leading the Manufacturing, Science and Technology, MS&T team. The site is currently expanding its capabilities and capacities, and there are future expansions planned.   Your strong technical knowledge and experience of transferring late clinical stage and commercial OSD projects will help you successfully oversee multiple projects in parallel.   Your excellent communication skills will ensure strong partnerships with customers, as well as internal departments.   This is a strategic role for the site and reports into the site head.

WuXi Advanced Therapies is a leading global cell and gene therapy contract, testing, development, and manufacturing organization (CTDMO) that is dedicated to advancing the development and commercialization of cell and gene therapies. Our values include innovation, excellence, and collaboration, which are reflected in our mission to accelerate the development and availability of life-saving therapies for patients in need.    Working at WuXi Advanced Therapies means being part of a dynamic, fast-paced, and innovative environment where you will have the opportunity to work on cutting-edge technology and make a real difference in the lives of patients. Our culture is collaborative and supportive, with a focus on teamwork and continuous learning.     Our benefits include: - 401K matching - PTO - Employee discount programs - Medical, dental and vision insurance - and much more The Laboratory Technician II - Mycoplasma performs basic assays to detect live mycoplasma contamination that may be present in biological samples 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). Under direct supervision, completes Test Methods and other required documentation and performs laboratory maintenance duties according to GLP, cGMP, CFR and/or PTC guidelines and SOPs. Performs additional Research & Development activities as assigned by Management 

Quality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer.   The position holder is responsible, within the frame of AS&T, of any testing-related topic to ensure the execution of new technology/product method transfer and/or validation, the creation of adequate testing methods and specifications and their associated training strategy and material, and, for the commercial testing, of owning the analytical method and of leading the investigation of any significant laboratory deviation.   As a member of the Quality Control Leadership Team (QCLT), the position holder is collaborating with the other members of the QCLT to ensure that the testing methods, processes, and techniques are maintained and improved and that any cGMP/GLP compliance issues is duly addressed in a timely manner.

After training has been completed on 1st shift, the supervisor will work the following: Quad 4: (Thurs – Sat, Alternating Wednesdays, 12hr Shifts, 2 pm - 2:30 am)   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).

Responsible for driving the company’s continued growth and carrying the sales targets for Toxicology, DMPK, and Bioanalytical service offerings from the Laboratory Testing Division. These services encompass services at discovery, development and clinical stages.  Serves as the primary commercial point of contact for the Division with key Pharma & Biotech stakeholders and decision makers, as well as key opinion leaders.  This position will be located in Southern California.