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Associate Director, Process Development

Oncorus, Inc. is an early-stage biotechnology company developing a next-generation immunotherapy platform to treat cancer. Oncorus was founded by MPM Managing Director, Mitchell H. Finer, PhD, a well-known biotechnology entrepreneur. Oncorus is a leader in corporate philanthropy, and has taken a pledge to donate a portion of product sales to fund promising cancer research and to support cancer care in the developing world. We are located in Kendall Square, Cambridge, MA.

We are looking for a highly motivated and innovative candidate for the role of Associate Director of Manufacturing and Process Development. Reporting to the Sr. Director of CMC Operations, this is a fantastic opportunity to make a significant impact as a scientifically motivated self-starter capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision.

Day to Day Accountabilities and Opportunities

  • As a leader of the Process Development team, the Associate Director of Manufacturing and Process Development will be responsible for overseeing process development, characterization and GMP manufacturing activities for Oncorus’ innovative oncolytic viral therapy platform
  • Direction of technical activities for upstream, downstream and formulation development activities to ensure scalable and commercially viable processes are developed
  • Responsible for all aspects of process scale up, technology transfer and GMP manufacturing
  • Participate or lead cross functional teams and report progress to senior management
  • Author CMC sections of regulatory documents
  • Provide tactical and strategic plans to prioritize and meet project milestones using a risked based approach to the development process
  • Ensure process development group best practices that are aligned with current GxPs
  • Collaborate with immunology, molecular biology, virology, and pharmacology/toxicology to identify efficiencies needed to meet critical corporate objectives, encompassing the area of oHSV development

Previous Experience

  • Ph.D. or M.S. degree in life sciences, chemical engineering, biochemical engineering, biochemistry, or closely related field is required
  • At least 5 – 8+ years of experience in industrial process development or manufacturing
  • Biotech experience is required (cell and gene therapy, virology or biologics preferred)
  • Understanding of upstream bioreactor production and downstream purification operations such as centrifugation, ultra-filtration and chromatography from pilot to GMP scale is required
  • Direct experience leading clinical or commercial stage programs and cross-functional team
  • Strong understanding of GxPs, process characterization/validation and technology transfer is required
  • Experience working in a regulated environment is a plus
  • Ability to work independently lead a cross-functional team to support corporate goals.
  • Ability to adapt to frequent change and thrive in a dynamic and entrepreneurial early-stage environment
  • Strong communication and organization skills, good working knowledge of MS office, data plotting and graphing software and DoE
  • Displays a high degree of maturity, honesty, trust and integrity Our Ideal Candidate
  • A scientifically motivated self-starter, capable of independently conceiving, conducting, and critically analyzing his/her own work with minimal supervision
  • A strong presenter and communicator, with the ability to work in a fast-paced and team- oriented environment
  • Someone who thrives on making a difference, as well as living with some ambiguity and change as we get off the ground
  • Someone who gets excited by a lean organization and never says or likes hearing “that’s not my job”
  • Someone who enjoys a transparent, respectful and innovative environment ​
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