QC Lead (Stability)

Location
Redwood City, CA
Posted
Apr 30, 2021
Discipline
Quality, Quality Control
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Contract
Adverum is looking for a Quality Control Lead (Stability) 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:
  • Coordinate all activities related to stability program, including but not limited to: track and receive incoming stability samples, schedule pulls and testing of stability samples, author and modify protocols for internal stability protocols; review and modify outsourced stability protocols.
  • Participate in the planning and review of stability design and/or protocol
  • Review, approve and organize product stability data and study report, address specifications or compliance challenges related to stability
  • Coordinate with supply chain and QC systems to finalize logistics for the stability protocol
  • Request, receive, properly store and stage stability samples for time point testing and/or ship samples for offsite stability testing, if needed and as described in the protocol
  • Generate interim and/or final stability reports using pre-defined template and completed stability testing
  • Review data, evaluate trending and perform statistical analysis
  • Review executed QC test records for product release, including the investigation and resolution of deviations, OOS and OOT observations.
  • Write, organize and review QC analytical result tables, protocols and reports.
  • Manage and build sample control processes for GMP release, stability, and/or additional test samples
  • 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

About you:
  • At least 5+ years in a GMP environment (pharmaceutical or biotechnology industry)
  • Proficient in analyzing data using statistical software such as JMP, MiniTab or PLA 3.0.
  • 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.
  • Knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industries required. Must have laboratory experience with a variety of analytical techniques 
  • 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.

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