The Role
The Quality Control Analyst will conduct release testing for clinical products, analyze data, guide junior staff, and engage in method validation and troubleshooting.
Summary Generated by Built In
Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
Note to Recruiters and Agencies
All recruiter and agency inquiries must go through Adverum’s internal Talent Acquisition team. Unsolicited resumes sent to Adverum will be considered Adverum's property. Adverum’s Talent Acquisition team must expressly engage agencies for any requisition. Direct contact with hiring managers by agencies will not be tolerated and may affect your ability to work with Adverum in the future.
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. Experience in some QC analytical assays such as qPCR, Potency, ELISA, SEC, DLS, Gels are preferred.
- 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+ years of experience 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.
Top Skills
Ce-Sds
Dls
Elisa
Empower Software
Hplc
Mass Spectrometry
Qpcr
Sec
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The Company
What We Do
Adverum Biotechnologies (NASDAQ: ADVM) is a clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary, intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies, designed to be delivered in physicians’ offices, to eliminate the need for frequent ocular injections to treat these diseases. Adverum is evaluating its novel gene therapy candidate, ixoberogene soroparvovec (Ixo-vec, formerly referred to as ADVM-022), as a one-time, IVT injection for patients with neovascular or wet age-related macular degeneration. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.
