Senior Associate, GMP Quality

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 Senior Associate, GMP Quality. The successful candidate will have extensive experience in batch record review and disposition, Quality Systems (Change Control, Deviations, CAPAs, etc.) and proactive GMP support of ongoing trials in all phases. Ophthalmology and/or oncology and medical device experience desired, but not required. This candidate will support the Director, GMP Quality in supporting the GMP activities in the execution of Aura’s drug development programs.

Responsibilities include but are not limited to:

  • Conduct and/or assist in internal audits (systems, processes, etc.)
  • Conduct external audits (includes, but is not limited to, CMOs).
  • Track and review audit responses and ensure acceptability of CAPAs.
  • Review batch records and associated documentation for drug substance, drug product and primary and secondary packaging.
  • Keep informed on changes to US and EU regulations as they pertain to manufacturing and distribution of product.
  • Provide GMP guidance to other functional areas, as applicable, based on interpretation of current regulations to ensure best practices including risk-based management.
  • Assist in the development of Inspection Readiness program and assist senior staff during regulatory inspections.
  • Work closely with CMC to provide proactive GMP compliance support and guidance.
  • Assist with departmental metrics trending and reporting.
  • Support creation or revision of SOPs, WIs, templates and forms.

Minimum Requirements:

  • BS in a life science field required.
  • Minimum of 5 years direct GMP pharmaceutical/biotechnology manufacturing experience; QA experience required.
  • Solid understanding and application of FDA regulations, ICH/GMP, GLP, MHRA, EMA, Health Canada.
  • Experience working within an electronic quality management system
  • 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

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