(Sr) Director, Product Quality

Brighton

Job Description Job Description Salary:

ABOUT AURA:

Aura Biosciences is a clinical stage oncology company. We are developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively, while activating the immune system to create long lasting anti-tumor immunity.

We have a goal of developing this technology in multiple cancer indications, focusing initially on two therapeutic areas – ocular oncology and bladder cancer – with a goal to expand into other areas of solid tumor oncology. Initially we have focused our clinical development in the medical field of ocular oncology, a group of rare diseases that have no drugs approved. We are in Phase 3 with our lead VDC AU-011 in choroidal melanoma.  We are also in development in non-muscle invasive and muscle invasive bladder cancer, currently in a Phase 1 trial.

We have commenced a global Phase 3 program investigating the delivery of AU-011 for the treatment of small choroidal melanoma and indeterminate lesions.  AU-011 has to date demonstrated an excellent efficacy and safety profile in Phase 2 for choroidal melanoma, and enrolment is ongoing in the pivotal Phase 3 trial.

Position Summary:

Aura Biosciences is actively recruiting for an (Sr) Director, Product Quality.  The successful candidate will have extensive experience in the oversight and management of all QC activities including QC testing in support of raw material, 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 (Sr) Director, Product Quality 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 (Sr) Director, Product Quality, 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 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 at to ensure testing is timely and performed in compliance with cGMP, established procedures and regulatory applications

Perform QC review of in process and release data and Certificate of Analysis per internal timelines, to support lot disposition.

Responsible for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs)

Establish and implement stability program for commercial and clinical products

Establish and maintain Aura’s specifications and sampling plans for in-process, drug substance, drug product, and stability. Manage implementation and changes in specifications at partner sites.

Collaborate on preparation of justification of specification.

Select and monitor metrics to identify risks and 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 8+ years experience in Quality Control for biologics, including 4+ years in a Quality leadership role

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.

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.

Extensive experience managing cGMP contract testing labs

Proven ability to troubleshoot operational and scientific questions, maintaining direction to a final solution.

Experience working with drug substance and/or drug product CMOs and participating in global cross functional and virtual teams.

Proven ability to manage projects and work with cross-functional teams comprised of internal and/or external contacts, including CTLs

Strong organizational skills to maintain a high level of productivity, innovation, and priority-setting in order 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