QC Analyst II/III

What you'll do:

• Conduct release testing in alignment with nonclinical and clinical viral vector products, adhering to GxP guidelines.
• Generating, analyzing, and interpreting analytical testing data for Drug Substance and finished products, ensuring the accuracy and reliability of the results
• Providing technical expertise as a subject matter expert in the implementation, execution, and troubleshooting of analytical methods within the testing laboratory, specifically focusing on SEC
• Develop, understand, follow, optimize, modify, and/or assist in the development of standard operating procedures (SOPs); partake in writing, reviewing, and revising SOPs.
• Carry out release, stability, and in-process testing of materials, samples, and final products.
• Execute analysis and interpretation of test outcomes, pinpoint deviations, and propose suitable recommendations.
• Engage in method and equipment qualification/validation studies; generate protocols, carry out and coordinate experiments, and draft reports.
• Possibly assist in assay development, nonclinical sample testing to support IND-path studies, and lead QC projects and investigations when necessary.
• Offer guidance to junior staff, apply technical knowledge daily, and may liaise with contract testing labs.

About you:

• Bachelor’s degree in chemistry, Biochemistry, or a related field, with a minimum of 2-3 years of experience (QC II) or 3-5 years’ experience (QC III) in HPLC, preferable in a bio-pharma analytical laboratory setting
• Proficient knowledge of calibration and operation of HPLC system with Empower software, along with hands-on experience in handling equipment like HPLC, PA800, Mass Spectrometry and others
• Laboratory experience with a range of analytical techniques including, but not limited to, SEC, CE-SDS, DLS and similar methods is required.
• Experience in quality control is desired to required based on the level; a solid foundation in molecular biology is desired. Experience with viral vector (adeno-associated virus) products is a plus.
• Must possess knowledge of cGMPs and regulatory prerequisites concerning the biotechnology and pharmaceutical sectors.
• Familiarity with statistical methods applicable to the analysis of experimental data.
• Proficiency in general and non-routine laboratory skills.
• Exceptional interpersonal, communication, and organizational skills are a must.
• Flexibility in problem-solving to achieve business goals, good oral and written communication skills are crucial. Proficiency in MS Office and equipment-related software like Soft Max Pro is desired.