Careers

QC Senior Manager/Associate Director, Stability

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 QC Sr. Manager/Associate Director of Stability.  The successful candidate will have extensive experience in the oversight and management of stability programs.  This individual will be responsible for leading all CMC stability studies for all phases of product development including commercial products as well as leading the Reference Standard program including qualification/requalification, storage, and distribution.

 

Responsibilities include but are not limited to:

  • Reporting to the Director of Quality Control, the Sr. Manager/AD of Stability is responsible for the implementation and execution of Aura’s stability program and reference standard program
  • Oversight and generation of stability SOPs, review and approval of protocols and reports
  • Manage and ensure timely completion of stability timepoint pulls as per relevant protocols and stability program SOPs. Manage stability sample inventory and related metrics.
  • Generate and present metrics for QC Stability in support of Quality Management Review and investigations.
  • Participate in the development and revision of product specifications; provide scientific input and statistical analysis of results.
  • Analyze stability studies for DS and DP for tracking and trending of quality attributes. Must be well versed in statistical analysis and ICH guidelines for expiry extension.
  • Maintain all Stability and Reference Standard data in a state of control, in compliance, and ready for inspections support.
  • Establish in-house reference standard program. Oversee the testing and qualification of reference standards.
  • Oversight and support stability sample shipments to contract laboratories and/or sample storage vendors
  • Perform QC stability data review as needed
  • Work closely with Manufacturing, Quality Control, Quality Assurance and Regulatory staff to resolve quality issues
  • Serve as SME for the review and approval of laboratory investigations, out of specifications, deviations, CAPAs, data interpretation/presentation, statistical analysis, and trending.
  • Actively support the preparation of CMC regulatory filings. Ensure compliance with stability requirements for CMC regulatory submissions.
  • Ensure timely notification and escalation of stability related issues.

Minimum Requirements:

  • BS or MS degree in a life sciences discipline with a minimum of 5 years’ experience in a GMP-regulated Biologics or Pharmaceutical environment 5+ years of experience managing Stability Programs for Biologics (both Biologics and small molecule a plus)
  • In-depth knowledge of ICH stability guidelines, method validation, expiry/re-test dating, excursion management and establishing specifications
  • Experience working with external contract testing labs is essential
  • Strong statistical analysis skills. Experience with statistical analysis software (JMP)
  • Proven ability to manage multiple projects and work with cross-functional teams comprised of internal and/or external contacts, including CMOs and CTLs
  • Strong technical writing skills with experience preparing: SOPs, analytical test reports, summary reports to support FDA/EMA filings. 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
  • Ability and willingness to travel domestically and internationally for audits as needed

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

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