Quality Control Lead
Redwood City, CA /
Research & Development – Quality Control /
Adverum is looking for a Quality Control Lead to join our team in our Redwood City office. This position reports into the Director, Quality Control. This person will be working with the QC team and cross-functionally. This individual will be a crucial member of the Quality Control team, contributing to the development and performance Quality Control (QC) methods, systems, policies, processes, procedures and controls as they relate to the analytical testing of clinical materials
What you'll do:
- Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
- Perform routine QC testing as needed
- Write, organize and review QC analytical result tables, protocols and reports.
- Work in conjunction with Assay Development department to qualify, validate and transfer QC analytical methods as applicable
- Manage and build sample control processes for GMP release, stability, and/or additional test samples
- Lead routine cell culture, reagent preparation, and other laboratory testing support activities
- Lead and/or review equipment/instrument IOQ/PQ (vendor)
- Implement and manage equipment/instrument maintenance/calibration
- Work with QC management to identify and mitigate risks to meeting QC milestones and goals.
- Coordinate with the Quality Assurance department for required review and approval of documents
- Oversee and provide direction to the direct reports under the guidance of the QC Management
- 5 to 7 years in a GMP environment (pharmaceutical or biotechnology industry)
- Solid knowledge and understanding of US and international regulations and guidance applicable to Quality Control and method validation
- Experience in quality control required. A strong background in molecular biology is desired.
- Experience transferring assays from Assay Development to Quality Control is required.
- Experience in assay qualification and validation strongly desired. Experience with viral vector (adeno-associated virus) product is a plus.
- Experience with adherent and suspension cell culture is required. Experience with HEK293 and Sf9 cells is a plus.
- Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Must have laboratory experience with a variety of analytical techniques including, but not limited to, quantitative PCR, ELISA, and cell-based methods.
- Knowledge of statistical methods applicable to the analysis of data.
- Proficient in general and non-routine laboratory skills.
- Experience working with contract testing labs.
- Excellent interpersonal, communication and organizational skills.
- Flexibility in problem solving, providing direction and work hours to meet business objectives. Good oral and written communication skills. MS Office skills; equipment related software such as Soft Max Pro 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