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.

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. 

The Project Manager will be responsible for managing projects within STA, WuXi’s API and Drug Product development and manufacturing division. Leads the orderly progression of projects from the proposal stage through project completion by interacting with the client, technical team and business development team. The incumbent will also participate in business development activities such as visiting existing or new clients and promoting STA’s services in conferences/trade shows. Please note this is a remote (work from home) position within the EU, and that English and Mandarin language skills are required.

As a Sr QC Analyst, with a CDMO organization, you will perform a wide variety of chemical or biological analyses on products, in-process materials, or samples in support of the company’s quality assurance and quality control program.

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.

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its Plate-based Pharmacology team. We’re seeking a highly skilled and motivated Scientist to develop assays in biochemical and cell based formats that are suitable for SAR screening in 96 or 384-well formats. Deep understanding of molecular biology and cell biology and experience in mammalian cell culture and compound handling techniques. Experience with methods such as luminescence, fluorescence, absorbance and radiometric detection is preferred.

This position is responsible for leading the business development activities in Scandinavia and key accounts in the European Union within the WuXi Discovery Chemistry Division. This position works closely with technical team, other BD team members and senior management team in China to develop and execute the most effective strategy to increase services along with project management in assigned area of geographic responsibility.    This position manages some key accounts and is also responsible for business development for new accounts.  This...

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 Aide.     Position Details: - Schedule: Tuesday - Saturday 9:00 AM - 6:00 PM (Saturday shift could start earlier) - Hours: Full-Time, 40 per...

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 -

Investigate and review non-conforming laboratory analytical chemistry testing results to determine root cause and product impact using root cause analysis, DSC, HPLC/UPLC; Conduct analytical chemical testing and laboratory investigations of OOS/OOT results for compliance with FDA regulations; Review and troubleshoot technical issues associated with biological laboratory testing, including ELISA, PCR, and virus testing; Provide cGMP guidance to ensure all non-conformances are closed to meet defined product release dates using Master Control, LIMS, Blue Mountain RAM; Develop and track CAPA plans for quality assurance; Evaluate trends in investigations and CAPA to identify major areas of...

HD Biosciences, Inc. (San Diego), a WuXi AppTec Company, is expanding its in vivo Pharmacology Division. We’re seeking a highly motivated Research Associate II to join the team.

As the Business Development Manager, you will spearhead activities to identify and nurture client business opportunities, leading to the expansion of the client base and revenue growth for OXGENE and WuXi Advanced Therapies.

The Business Development Manager will cultivate growth of WuXi AppTec’s Medical Device Business. The role calls for dedicated and passionate candidates with strong communication and analytical skills, as the position will be central to developing sales initiatives, garnering support directly from clients through traditional sales channels, as well as working with internal stakeholders within multiple business & departmental functions to maintain a foundation for effective business collaboration and enhanced customer experience. Strategic planning, sales, sales-support processes, marketing & promotions will be routinely engaged in this role.

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:  This is a night shift role.  Schedule is Monday - Friday and hours from 6:00pm - 2:30am

This individual will be responsible for performing the technical aspects of assigned tests in compliance with GLP, USDA and AAALAC guidelines.   Position Details: - Sunday to Thursday 7 AM to 3:30 PM (Training on Monday to Friday) - Anticipated Compensation: $19 per hour - Full-time position offering competitive benefits including Health, Vision, and Dental Insurance, 401K matching, and paid time off

HD Biosciences, a WuXi AppTec company is searching for a Director- In Vivo Pharmacology to manage team and project operations. The candidate must provide leadership, scientific, and operational support for a diversified research staff. This role requires experience and an established track record in working with multi-functional teams outside their reporting structure and presenting research strategies and results. Along with scientific strength, the successful candidate must have a proven track record of instilling teamwork and operational excellence while successfully executing against objectives. This key position will report directly to the head of In Vivo Pharmacology Department.

This position is responsible for processing samples for assigned tests in compliance with GMP, ISO, and other standards including test sample log in and accountability. The position also includes the ordering and receiving of supplies and reagents used by the laboratory.

The Chemistry Specialist position involves performing routine and non-routine tasks in a regulated chemistry laboratory environment. Individuals in this role are expected to demonstrate proficiency in wet chemistry techniques, lead complex sample extractions, perform research and development (R&D) and process improvement activities, and collect data using Fourier Transform Infrared Spectroscopy (FTIR) and Ion Chromatography (IC).

Pharmaceutical Manufacturing: The EHS Specialist II will be responsible for supporting EHS compliance and risk management within the PHL Campus. The EHS specialist will monitor and improve processes to prevent and eliminate injury and illness to employees and assist the company to comply with safety laws.

Works closely with Quality Assurance Management, Quality Assurance Managers and support functions in providing direct oversight and leadership in the support of Late Phase and Commercial Manufacture of Cell Therapy Products according to current Good Manufacturing Practices (cGMPs).  Direct department employees, resources and programs to ensure compliance with all regulatory requirements; specifically Good Manufacturing Practice (cGMP), Code of ederal Regulations (CFR), EU Guide to Good Manufacturing Practice, International Conference on Harmonization (ICH), Good Tissue Practices (GTP) and relevant foreign regulatory guidelines for biopharmaceuticals. Ensure compliance of critical functions for the site, monitor, trend and report on all...