Senior Quality Assurance Specialist (Operations)

Oncorus is a clinical-stage biotechnology company focused on developing next-generation viral immunotherapies to transform outcomes for cancer patients. Based in the Andover, MA biotech ecosystems and backed by a group of leading institutional life sciences investors, we are advancing a portfolio of intravenously and intratumorally administered viral immunotherapies based on our viral RNA constructs using our lipid nanoparticle (LNP) delivery system (our vRNA/LNP immunotherapy platform) and our oncolytic herpes simplex virus-1 (our HSV platform) for multiple indications with significant unmet needs. Our team is driving innovation and engineering multiple candidates with both platforms to enable the full potential of this exciting therapeutic class. We believe every cancer patient deserves a better outcome. And we’re working with urgency to make that happen. Please visit www.oncorus.com to learn more.

The individual in this position is responsible for Quality Operations support of both internal clinical manufacturing at the Oncorus GMP manufacturing facility (located in Andover, MA) as well as external contract manufacturing organizations (CMOs). Specific responsibilities include, but are not limited to, Quality support/oversight and leading initiatives related to: tech transfer and facility start-up, system implementation, floor operations, master batch record (MBR) and standard operating procedure (SOP) generation/revision, review and approval, record and investigation review, controlled document generation, material/batch disposition, training, etc.

This position is an onsite role. 

• Support the organization in maintaining inspection readiness by enforcing adherence to cGMPs, standard operating procedures, and industry best practices.
• Support the Company’s GMP manufacturing facility in Andover, MA as a member of the Quality Operations team.
• Provide on-the-floor Quality support to manufacturing and make quality decisions and/or escalate issues to management that may impact operations.
• Perform routine walkthroughs of the manufacturing suites partnering with the manufacturing team on suite maintenance, Quality best practice implementation and troubleshooting when issues arise.
• Support visual inspection activities as needed.
• Author, review, and approve GMP documentation (SOPs, master batch records, executed batch records, testing records, protocols and associated summary reports, test methods, specifications, deviations, change controls, corrective/preventive actions, out-of-specification/atypical investigations, etc. to ensure GMP compliance, that all steps have been executed correctly, and that all limits and specifications have been met).
• Perform batch disposition of incoming raw materials, consumables, Cell Bank, Plasmid, Drug Substance, Drug Product (including labeled and packaged materials).
• Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
• Independently handle complex investigations in cross-functional areas.
• Anticipate issues and escalate to appropriate management attention immediately.
• Exercises judgment in resolving moderate to complex quality issues.
• Act as QA liaison to site personnel to provide quality system expertise to help identify solutions and ensure compliance to cGMPs.
• Plan and execute work independently and consult with supervisor as needed.
• Assist with internal and external audits as required.
• Support generation of metrics for Management Review.
• Support quality functional groups on an as needed basis.
• Provide QA oversight for cGMP activities outsourced to contract organizations.
• Practice safe work habits and adhere to Oncorus’ safety procedures and guidelines.
• May be asked to provide support for a morning or evening shift schedule as business needs dictate.
• Other duties as assigned by management.

• Bachelor’s degree in biology, chemistry, or other life science and at least 8 years relevant industry experience in Quality Assurance in a Pharmaceutical/Biotech GMP environment or Master’s degree in biology, chemistry or other life science with at least 6 years’ relevant industry Quality Assurance experience.
• Excellent verbal and written communication skills.
• Experience supporting Quality Operations required. Experience with both early and late phase clinical manufacturing preferred.
• A working knowledge of cGMP requirements for Clinical Trial Material in both the US and EU including sterile manufacturing strongly preferred.
• Experience with cell, protein, RNA, and/or viral products preferred.
• Experience with cell culture, single-use technologies, and aseptic processing preferred.
• Understanding of regulatory guidance on cell and gene therapy products.
• Expertise working within cGMP compliance and providing GMP documentation.
• Strong communicator and collaborator who possesses a flexible approach to problem solving and ability to apply risk-based decision making.
• Proven ability to work independently as well as to collaborate with peers and work effectively in a team-oriented environment; highly organized.
• Experience with GMPs in a working manufacturing environment strongly preferred.
• Investigational skills including Root Cause Analysis and Product Impact Assessments.
• Ability to manage multiple projects with minimal oversight in an evolving environment.
• Previous experience gowning.