Oncorus Principal Scientist, Synthetic Virus Process Development in Cambridge, Massachusetts
Principal Scientist, Synthetic Virus Process Development
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, MA biotech ecosystem 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 a stellar candidate for the role of Principal Scientist, Synthetic Virus Process Development to lead technical CMC activities of our oligonucleotide and lipid nanoparticle based synthetic oncolytic viruses. Reporting to the Director of Process Development, this individual will be a technical and development leader for our novel lipid nanoparticle programs. Along with the CMC, Research and Clinical teams, this individual will work both internally and externally to identify the appropriate CMOs that will be able to deliver cGMP material to our clinical team and support future IND submissions. This individual will play an enormous role helping us to realize the full potential of our synthetic oncolytic virus programs, starting with the first clinical candidate. Additionally, this individual will be a motivated leader, with a passion for bringing new treatments forward, a strong presenter and communicator, with the ability to work in a fast-paced and team-oriented environment. This individual will be excited by a lean and changing organization, by the opportunity to ?wear multiple hats?, have a proven track record of taking pre-clinical programs from development to clinical proof of concept and beyond, all while enjoying a transparent, outcomes-oriented, respectful, and innovative environment.
This is also an opportunity to grow as a leader in the CMC Operations group and to be a part of a groundbreaking, growing company.
Duties And Responsibilities:
Partnering with the Research and Process Development Teams and external consultants to translate our science into an efficient GMP manufacturing process
Contributes to process definition, CMO selection, facility fit assessment, and development of batch production records
Using risk-based approaches and a deep understanding of chemistry and engineering principles, design and conduct experiments to identify and optimize critical process parameters and characterize early and late stage drug product manufacturing processes
Manage relationships with CMOs and other vendors
Work with the analytic assay development team to establish methods for oligonucleotide and lipid nanoparticle characterization
Prepare and review GMP and regulatory documents such as batch records, deviations, investigations, and IND sections
May provide supervision to junior staff contributing to process development and technical operations for Oncorus Synthetic Virus programs
Required Education, Skills and Experience
Bachelor?s or Master?s degree (+10 years) or PhD (+6 years) experience in research, development, or manufacturing of biologics
Degree in Chemical Engineering, Chemistry, Biomedical Engineering or Pharmaceutical Sciences or related field required. Advance degree preferred
Demonstrated leadership in process development, scale-up, tech transfer, and external manufacturing
Familiar with cGMPs as applied to large biomolecule production and purification
Knowledge of bioprocess purification unit operations as applied to protein, viruses, DNA, RNA, or similar biomolecules
Experience developing oligonucleotide therapeutics and/or lipid nanoparticle drug products preferred
Deep understanding of analytical methods required for development and characterization of oligonucleotides, and lipid nanoparticles desired
Experience in authoring and reviewing regulatory documents and preparing CMC sections
Strong interpersonal and collaboration skills
Excellent written and oral communication skills
Strong mentorship abilities
Benefits and Perks
Oncorus, Inc. is an Equal Opportunity Employer, and offers a comprehensive benefits package including health, dental, life insurance, 401k, unlimited vacation and much more.
Job Type: Full-time
Travel: up to 25% of time
Salary: commensurate with role and experience