External QC Manager

Location
Redwood City, CA
Posted
Mar 18, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
Adverum is looking for External QC Manager to join our team in our Redwood City office. This position reports to the Director of Quality Control.  This role is responsible for supporting the planning, execution, and management of external or transfer projects in the Quality Control team through collaboration with external/CDMO Quality Units.
 
This role will be responsible for overseeing method transferring activities between multiple internal parties (Quality control and Assay Development) and to external CDMO parties in partnership with the External Manufacturing and Supply Chain groups. As such, the ability to quickly create strong working partnerships with peers and members of these groups, as well as with Analytical Development, Manufacturing, Quality Assurance and Program Management, will be key for success.
This role requires a strong attention to detail, but also the capacity to see the larger picture, the ability to work collaboratively and efficiently with many cross-functional partners, and a strong organizational mind.  Prior experience carrying out method transfer activities for a viral gene therapy process is a plus.
What you'll do:
  • Manage transfer of analytical methods for drug substance and drug product formulations to established and prospective, domestic and international, CDMO partners.
  • Review executed QC test records for product release, including the investigations, OOS and OOT observations from CDMO partners
  • Author/Review analytical method and technical reports, validation protocols, validation reports, stability protocols and related documents from CDMO partners.
  • Coordinate with the Quality Assurance Department for timely review and approval of documents
  • Serve as a QC subject matter expert and partner with External Manufacturing to support and manage our external CDMO partners (when safe to travel, an estimated 10-15% travel will be required).
  • Provide input, authorship, and review on relevant CMC sections of various regulatory submissions as needed.
  • Work with QC management and project manager to identify and mitigate risks to meeting QC milestones and goals.
  • Participate in continuous improvements of quality systems (procedures and systems) to improve organization effectiveness, quality assurance compliance, and regulatory and other requirements
  • Responsible for development of direct reports
  • Assist in sample shipment coordination activities from CDMO to contract testing laboratories
  • Other responsibilities may be assigned as needed

About you:
  • 5 to 7 years in a GMP environment (pharmaceutical or biotechnology industry) with at least 3 years in QC management role or equivalent
  • 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 or Quality Control to CDMO partners is a plus.
  • Experience with oversight of vendor relations is required
  • Experience in assay qualification and validation strongly desired. Experience with viral vector (adeno-associated virus) product is a plus.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Must have knowledge in 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.

About Us
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