Director, Quality Control

Position Title: Director, Quality Control

About Aura: At Aura Biosciences, we are developing a new class of therapies to target and destroy cancer cells selectively, while leaving surrounding tissue unharmed – an approach we call molecular surgery.  By safely eliminating cancer locally, we can treat early and transform the lives of people with a wide range of cancers that are poorly managed today.

Our lead program in ocular melanoma is designed to remove cancer cells in the back of the eye as a first-line therapy potentially long before the disease progresses and metastasizes to the liver, where it almost always is fatal. Development of a first-in-class treatment option to selectively destroy cancer cells would create the possibility of a cure in this and other cancers where the disease can be detected early.

Position Summary:

Aura Biosciences is actively recruiting for a Director of Quality Control.  The successful candidate will have extensive experience in the oversight and management of all QC activities including QC testing in support of raw materials, in-process, drug substance, and finished products. Experience in oversight of external testing laboratories and contract manufacturing organizations is essential. This position will be expected to work in a highly collaborative, cross functional team environment, and provide expert knowledge to the development, implementation, and maintenance of QC systems and activities, including testing, specifications, stability, reference standard, raw material programs.  The QC Director will provide expert technical support for method development, transfer, qualification, validation, and laboratory out of trend (OOT) and out of specification (OOS) investigations.

Responsibilities include but are not limited to:

  • Reporting to the VP of Quality, the Director of Quality Control, is responsible for the development and execution of Aura’s QC operational strategy
  • Serve as the QC subject matter expert working in collaboration with external CMOs and CTLs to ensure methods are suitably transferred, qualified, and validated to support clinical and commercial processes
  • Develop collaborative and effective working relationships with our CMO and CTL partners, external vendors, and suppliers
  • Oversee all in-process, release, and stability analytical testing to ensure testing is timely and performed in compliance with cGMP, established procedures and regulatory applications
  • Perform Certificate of Analysis review and approval per internal timelines, to support lot disposition
  • Responsible for Quality System records associated with QC testing (change control, lab investigations, OOS, deviations, and CAPAs)
  • Establish and implement ICH stability program for commercial and clinical products; and assist Analytical Development on all development stability studies
  • Establish and maintain Aura’s specifications and sampling plans for in-process, drug substance, drug product, and stability. Manage implementation and changes to specifications at partner sites
  • Collaborate on preparation of justification of specifications
  • Select and monitor metrics to identify risks, priorities, and improvements initiatives
  • Actively support the preparation of CMC regulatory filings including methods, batch analysis, and stability sections
  • Generate relevant QC and Stability SOPs
  • Lead the creation and roll out of a Product Quality Monitoring Program and Reference Standard Program
  • Assure ongoing readiness for regulatory inspection; participate in audits and inspections, and prepare responses to correspondence and findings, as needed
  • Recruit, train, and develop a team of Quality Control professionals as needed

Minimum Requirements:

  • Requires an MS or PhD in Analytical Chemistry, Biochemistry, or related field with 10+ years of experience in Quality Control for biologics, including 5+ years in a Quality leadership role
  • Experience in QC support of large molecule DS and DP manufacturing at various stages of development (preclinical, clinical and commercial preferred). Experience in QC of both large and small molecule is a plus
  • In-depth knowledge of ICH guidelines in support of cGMP operations supporting clinical manufacturing, including stability, method validation, expiry/re-test dating, and establishing specifications
  • Extensive experience managing cGMP contract testing labs
  • Proven ability to troubleshoot operational and scientific questions, maintaining direction to a final solution
  • Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs and CTLs
  • Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting to complete assignments on-time and on-budget
  • Excellent written and oral communications skills
  • A well organized, self-motivated, and independent work style with the ability to initiate and follow through on assignments
  • Excellent interpersonal skills with knowledge of basic negotiation, influencing and conflict management to assure effective interactions within and across departments
  • Ability and willingness to travel domestically and internationally for audits as needed



Interested?  Email a cover letter and a copy of your CV to referencing the position description in the subject line.