• Job Description

  Req#: 12266

  Overview

  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 parent company, WuXi AppTec has over 1,800 US-Based employees located with 11 facilities in 8 states. Globally WuXi AppTec spans to more than 39,000 employees with 32 facilities in 9 countries.

  The Associate Research Scientist: Designs and executes research & development Next Generation Sequencing and new technology sequencing studies, assay qualifications and test article validations under limited supervision. Drafts test methods and clearly documents all experiments according to SOPs and cGMP guidelines. Acts as a Technical Reviewer and assay trainer. Partners with Testing Operations during assay transfer and validation activities.

  Responsibilities

  • Designs and executes R&D Next Generation Sequencing, High-Throughput Sequencing and Long-Read Sequencing studies under limited supervision.
  • Performs nucleic acid isolation, prepares libraries, and operates Next Generation and Third Generation Sequencers.
  • Executes Qualification Protocols (QP) and Validation Protocols (VP) and other GMP methods. Drafts QP or VP under minimal supervision of supervisor or technical lead.
  • Drafts test methods/ reagent protocols (RPs)/SOPs. Drafts client protocols under minimal supervision.
  • Participates in assay transfers to Operations. Serves as trainer for inter- and intra-departmental staff.
  • Writes research and development reports and ensures data are reported clearly and accurately.
  • Reports observations of ongoing tests to appropriate internal staff and clients, as needed.
  • Author and execute installation qualification and operational qualification (IQOQ), author equipment SOP, as needed.
  • Conducts and directs assays and lab procedures according to and in compliance with cGMP, CFR and/or PTC guidelines and SOPs.
  • Demonstrates solid proficiency in scientific theory and rigorous practical application in the completion of lab procedures.
  • Conducts critical review of results and interprets the data. Draws conclusions and plans next steps for assay development or troubleshooting.
  • Serves as technical reviewer and LIMS tech manager.
  • Participates in client calls and face to face meetings with assistance by departmental senior staff.

  Qualifications

  Bachelor's degree and at least 4 years relevant, hands-on lab experience or Master's Degree with 2 or more years of relevant experience.

  Knowledge / Skills / Abilities:• Experience with Next Generation Sequencing and / or Long-Read Sequencing, including library preparation. Hands on experience operating Ion Torrent or Illumina or Nanopore sequencing instruments.• Experience with DNA and RNA extraction, qPCR, and molecular biology techniques.• Experience with droplet digital PCR is highly desirable.• Familiarity with gene therapy vectors and/or gene mediated cell therapy is desirable.• Experience in a cGMP environment is highly desirable.• Ability to use judgment as dictated by complexity of situation.• Ability to work under limited supervision and to handle problems of a more difficult nature.• Ability to accomplish the described duties through the use of appropriate laboratory equipment and computer equipment and software.• Ability to record data accurately and legibly.• Proficient in Oral & Written communication skills.

  Our Values:

  Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.

  Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.

  WuXi AppTec provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.

• About the company

  WuXi AppTec is a global pharmaceutical, biopharmaceutical, and medical device company.

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