WuXi AppTec

Associate Director, Peptide/Oligonucleotide Analytical

Job Locations CN
Job ID
2021-8558

Overview

STA Pharmaceutical Co., Ltd., a WuXi AppTec company (WuXi STA), is a global leading small molecule pharmaceutical development and manufacturing capability and technology platform company serving the life science industry, with operations in China and the United States. As a premier Contract Development and Manufacturing Organization (CDMO), STA offers our worldwide partners efficient, flexible and high-quality solutions for small molecule Active Pharmaceutical Ingredients (APIs) and finished dosage forms.

  • A Leading Company of Contract Development and Manufacturing Organization(CDMO)
  • The World’s Largest Process Chemistry Team
  • To learn the most cutting edge technologies in the pharmaceutical development field
  • To work with 200+ global new drug development companies
  • Systemic and Multiple Training Programs(Technical/Soft skills/Management)
  • Diversified Career Development and Promotion Trails

 

Job Location: Wuxi City, Jiangsu Province

Responsibilities

  • Play a leading role in the analytical method development and validation for peptide/oligonucleotide drug products utilizing a variety of analytical techniques.
  • Implement analytical methods for in-process testing, release and stability testing of peptide/oligonucleotide drug products.
  • Lead mass spec characterization of peptide/oligonucleotide drug products at various stages of development.
  • Design and execute experiments with a high level of independence. Analyze, interpret, and deliver results in timely fashion.
  • Assess in-house equipment and propose/assess outside technologies that can benefit projects.
  • Provide qualified technical guidance to junior staff members.

Qualifications

  • Ph.D. in Analytical Chemistry or related discipline with at least 5 years, or M.S. with at least 8 years or B.S. with at least 10 years of industry experience.
  • Solid understanding of GLP and GMP requirements and their application in a phase appropriate manner.
  • Strong understanding of method development for peptides and oligonucleotides.
  • Experience in a wide variety of analytical techniques including liquid chromatography, mass spectrometry, UV, SEC, etc.
  • Familiarity with USP monographs and chapters, and ICH/FDA guidance documents related to analytical method transfer and validation, impurities, mutagenic impurities, etc.
  • Strong communication skills and ability to provide cross-functional leadership and guidance.
  • Excellent technical writing skills and attention to details in authoring methods, specifications, technical reports and regulatory filing documents
  • Demonstrate a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.

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