QC Analyst II/III
Adverum is seeking a dedicated Quality Control Analyst to be a part of our vibrant team based in our Redwood City office. Reporting variably to the Quality Control Manager, Quality Control Lead, or as a part of a project hierarchy, this role will engage collaboratively with the QC team and other cross-functional teams. As a vital member of the Quality Control unit, the analyst will play a significant role in advancing and performing Quality Control (QC) techniques, systems, policies, processes, procedures, and controls pertinent to the analytical examination of clinical materials.
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.
- 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.
Adverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum’s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.
At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation