WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Sterility Department for an Associate Lab Technician.     Position Details: - Schedule: - Monday - Friday 7AM to 4:00 PM -

 Responsible to ensure assistance with the day-to-day operation, maintenance, and repairs of the mechanical and utility systems associated with the STA San Diego facility. This includes the building HVAC and chiller systems, house vacuum pumps, compressed air system, liquid nitrogen tank and distribution system, electrical system, boiler system, laboratory and Kilo Lab fume hoods, and associated utilities/equipment in the Pilot Plant. This may include assisting with maintenance/repairs as well as working with various external contractors and service providers.

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening in our Quality Department for an Associate Compliance Analyst.   Tuesday to Saturday 8 AM to 5 PM

Job Summary:   The Validation Technician, Validation Operation Services performs validation and qualification activities. They assure compliance of these activities with cGMP as well as with internal policies and procedures. The Validation Technician is authorized to direct external vendors performing work in this field.

This position is responsible for leading the business development activities in The EU within STA, WuXi’s CMC small molecule development and manufacturing division. The position works closely with STA’s other BD team members and senior management team in China to develop and execute the most effective strategy to increase small molecule Drug Substance, Drug Product, API and intermediate sales in their area of geographic responsibility. This position manages sites for key accounts and is also responsible for business development for any new accounts. This position works...

The Senior Application Scientist is primarily responsible for designing, developing, validating, and conducting complex qualitative and quantitative chemical analyses and experiments using LCMS, HPLC, GCMS, HS-GCMS, and other chromatography/spectroscopy instrumentation as needed. The individual will troubleshoot, maintain, run instruments and will lead, oversee, and execute R&D experiments to address regulatory gaps and solve compliance issues.

The Application Scientist will help develop and conduct qualitative and quantitative chemical analysis and experiments using the appropriate equipment and analytical techniques for medical device testing. The individual will perform a variety of analytical tests, prepare samples/standards/reagents, troubleshoot, maintain and run instruments. The position will also include techniques such as solvent exchange, concentration or dilution; standards and reagent preparation as needed to support laboratory operations. Additionally, this position is responsible for processing samples for assigned tests in compliance...

The Senior Chemistry Specialist position involves performing routine and non-routine tasks in a regulated analytical chemistry laboratory environment. Personnel in this role are expected to be able to handle samples, demonstrate proficiency in wet chemistry techniques, perform research and development (R&D) and process improvement activities, and acquire data in instrumentation such as, but not limited to, Liquid Chromatography-Mass Spectrometry (LC-MS), Gas Chromatography-Mass Spectrometry (GC-MS), Ion Chromatography (IC), and/or Inductively Coupled Plasma-Mass Spectrometry (ICP-MS). This role requires maintaining laboratory equipment. Additionally, this role includes implementing a functional medical device extraction process with a strong focus on...

Develop, validate, and provide support for sterilization, cleanroom, and contamination control related processes between various facilities, supporting testing and contract manufacturing.   Position Details: - Full-Time - Monday to Friday Standard Business Hours - Location(s): St Paul, MN (preferred) or Atlanta, GA -

With supervision serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab LM Bioanalysis assays issues and assist in training of LM analysts on wet lab LM systems. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.   This is a contingent (temporary) position that is not eligible for employee benefits. 

The incumbent will lead a team to cultivate business relationships and opportunities to generate revenue with prospective and existing clients for WuXi TIDES, a WuXi AppTec company, in particular to support the growth of the rapidly growing oligo and peptide (O&P) Contract Research, Development and Manufacture (CDMO) business. The candidate will work closely with the U.S. and Europe business development leaders to pursue new business leads; follow up on critical issues and aid in attending to customer inquiries. Assists marketing in delivering content and driving the success of new and existing services.

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 EHS Specialist will be responsible for maintaining and managing day-to-day health, safety, emergency response, environmental compliance and security activities. The EHS specialist will also be responsible for the overall environmental compliance for two different sites in Saint Paul, MN and Atlanta, GA and will serve as Safety and Radiation Officer. Therefore, time will be split between the two sites at approximately Saint Paul, MN (80%) and Atlanta, GA (20%) The EHS specialist will monitor and improve processes to prevent and eliminate injury and illness to employees and ensure the company complies with safety and environmental laws.  

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 accountable for the Quality Control activities at the OSD drug product manufacturing site of Couvet, Switzerland, including method transfer / verification, the analytical & microbiological testing of incoming materials, packaging components, in-process testing, drug product & drug substance release testing and stability testing, as well as equipment cleaning residual testing and support the manufacturing related area operation such as environment monitoring.  You will ensure activities meet cGMP requirements and customers’ expectations.

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is seeking a highly skilled and motivated Scientist to lead our histology lab in in vivo pharmacology team for various projects.

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 Senior Analyst is part of the Quality Control (QC) department of STA Pharmaceuticals Switzerland. He/She is responsible for executing protocols for method validations, verifications and transfers for the QC Laboratory. The position will also perform all testing of both material and finished product in support of the larger product introduction activities e.g. testing of samples for stability registration studies, process validation or cleaning validation. Additional duties includes participation to investigations in case of deviations, cleaning validation, preliminary testing, and preparation or review of documentation

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.