WuXi AppTec

QC Analyst

US-CA-San Diego
Job ID
2017-3235

Overview

This position reports to the Analytical Chemistry Department at STA Pharmaceutical US LLC. STA Pharmaceutical US LLC, a WuXi AppTec Company, is a contract development and manufacturing organization focused on providing high quality process development, R&D, GLP Tox lots and up to P1/P2 GMP small molecule manufacturing services to the biopharmaceutical industry. The candidate will work with a team of analytical scientists/chemists in conjunction with the Chemical Research and Development Department and assist in developing, safe, efficient and easily scalable processes for producing starting materials, intermediates and active pharmaceutical ingredients (API’s). In addition, the candidate will work with Quality Assurance to ensure that high quality standards are maintained and appropriate documentation such as analytical test release packages are completed in a timely manner. The candidate will have shown proficiency in on-bench analytical work, solve analytical challenges, and have extensive experience in writing analytical reports. The position requires a strong background in drug substance/drug product analytical method development and validation, as well as thorough knowledge of analytical equipment and cGMPs ICH and relevant FDA guidelines. CMO/CRO experience is beneficial.

Responsibilities

  • Perform analytical testing in support of API manufactured at STA San Diego. This includes method transfer, method validation, as well as, IPC’s, cleaning verification, sampling and testing of raw materials, intermediates, API’s using current pharmacopoeias, any associated ‘wet’ chemistry and instrumental techniques (HPLC, GC, IR, KF), as appropriate. .
  • Preparing Quality reports, including analytical reports (for raw materials and finished products), Certificates of Analysis (CoA) (for finished products) and stability reports.
  • Writing analytical specifications using current pharmacopoeias and reviewing existing analytical specifications
  • Maintenance of analytical equipment including calibration/qualification and system suitability testing for cGMP activities.
  • Adhere to cGMP compliant procedures and data management systems to archive and track analytical activities.
  • Authors SOP’s, technical reports and sections for regulatory filings.
  • Actively communicates, consults and collaborates with colleaguesto ensure optimal execution and record of analytical activities.
  • Observing and complying with company Health and Safety Policies

Qualifications

  • Significant experience in analytical method development, validation and QC testing for small molecules.
  • Experience in supporting all phases of API/DP development, ideally spanning early development to registration.
  • Demonstrate understanding of cGMP manufacturing for biopharmaceutical products.
  • Highly proficient in the use of key analytical equipment (HPLC, GC, IR, URV, KF) and the testing of finished products.)
  • Can work independently with minimal supervision
  • Demonstrated success working effectively outside typical procedures when required
  • Ability to work accurately in a busy and demanding environment, adhering to strict deadlines/timescales
  • Self starter who can ‘hit the ground running’.
  • Ability to achieve and maintain high standards with meticulous attention to detail
  • Provide technical and trouble-shooting support for analytical instrumentation and all analytical development activities.
  • Provide regular updates, documentation and communication of analytical development results to supervisor and development team, if needed.
  • Collate and present results in various forms, such as, technical reports and oral presentations.
  • Credible and confident communicator (written and verbal) at all levels
  • BS in analytical chemistry or related field with 2-5 years of relevant experience as a QC Analyst or analytical chemist

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

 

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