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 / Changzhou City, Jiangsu Province

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.

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.