Oncorus Associate Director, Analytical Development in Andover, Massachusetts
Oncorus is a clinical-stage biotechnology company focused on developing next-generation viral immunotherapies to transform outcomes for cancer patients. Based in the vibrant Kendall Square and Andover, MA biotech ecosystems and backed by group of leading institutional life sciences investors, we are advancing a portfolio of intratumorally and intravenously administered viral immunotherapy candidates based on our oncolytic herpes simplex virus-1 and synthetic virus platforms for multiple indications with significant unmet needs. Our team is driving innovation and engineering multiple candidates with both platforms to potentially enable us to deliver on 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.
Oncorus is looking for an Associate Director to lead the team responsible for the development of analytical methods to characterize both HSV-1 and Synthetic oncolytic viruses. This individual will join an early-stage, multidisciplinary team of scientists and engineers and contribute to a variety of CMC activities in a highly collaborative environment. The right individual will play an enormous role helping Oncorus realize the full potential of our oncolytic virus programs, including Oncorus? first clinical candidate ONCR-177. This is an opportunity to grow as a leader in the CMC group and to be a part of a groundbreaking, growing company.
Day to Day Accountabilities and Opportunities:
Selecting, developing, and qualifying phase-appropriate test methods for the characterization of HSV and Synthetic oncolytic viruses
Interfacing with contract research organizations (CROs) and collaborators to lead method transfer and method qualification activities
Building and managing a high performing team of analytical scientists with a focus on quality results, career growth and culture
Leveraging regulatory guidance and Quality-by-Design principles to develop robust analytical methods
Authoring SOPs, method and instrument qualification protocols, reports, certificates of analysis, and CMC sections of regulatory filings
Serving as a subject matter expert and aiding in the investigation of out of specification or out of trend analytical results
Work closely with Quality Control to transfer, qualify and troubleshoot analytical methods used for product characterization and release testing.
Planning, executing, documenting, and analyzing experiments, and presenting results thereof to a multidisciplinary team
Bachelor?s or Master?s degree (+10 years) or PhD (+6 years) experience in analytical development or quality control of biologics, viral products, or gene therapy products
A strong background in characterization of biologics, viral products, or gene therapy products, including chromatographic, electrophoretic, spectroscopic, and biophysical characterization techniques
Deep understanding of analytical methods required for development and characterization of viral products desired
Experience transferring methods and managing relationships with CROs or CMOs
Excellent critical thinking abilities plus exceptional verbal and written communication skills
Demonstrated ability to work independently and manage team members in a fast-paced R&D environment
Experience in authoring and reviewing regulatory documents and preparing CMC sections
Our Ideal Candidate
A motivated leader, with a passion for bringing new treatments to the bedside
A strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment
Someone who is excited by a lean and changing organization, and by the opportunity to ?wear multiple hats?
Someone who wants to help usher in the next step change in outcomes for oncology patients
A proven track record of taking pre-clinical programs from development to clinical proof of concept and beyond
Someone who enjoys a transparent, outcomes-oriented, respectful, and innovative environment
Job Type: Full-time
Salary: commensurate with role and experience
Oncorus, Inc. is an Equal Opportunity Employer, and offers a comprehensive benefits package including health, dental, life insurance, unlimited vacation and much more.