Process Development Scientist

SUMMARY:

We are seeking an energetic and motivated scientist to join GIVAX. In this role, you will be part of a team that is working on the molecular biology and immune evaluation of viral vector backbones and candidate vaccine viruses. As a Process Development Scientist, you will be responsible for supporting the team in moving the vaccine/s into clinical ready products for Phase 1 and beyond. You will have the opportunity to work with some of the world’s leading scientists in the field of vaccine development to bring our flagship program from discovery to industrialization. We are seeking an innovative mind with expertise in viral molecular biology and particularly reverse genetics technology.

Leveraging previously acquired academic and/or work experience, the Process Development Scientist will be responsible for development of a small-scale manufacturing process, formulation development and development of methods to characterize the product and process. The incumbent will report to the Technical Project Lead and will also work in close collaboration with the Head of Operations. In addition to the internal staff, the incumbent will work in close collaboration and key partners to plan and execute the research that will lead to the generation of our vaccine candidates.

Responsibilities

• Please note: The percentages listed below are related to the expected effort distribution for this role

Laboratory Research (70%)

• Develop small-scale manufacturing process based on licensed live attenuated rotavirus vaccines, optimized for maximized yield and recovery
• Source and test animal origin free, chemically defined reagents to use in manufacturing process
• Execute process development experiments to support process definition
• Plan and run experiments to select best formulation based on licensed LAV rotavirus vaccines
• Develop methods to characterize the process, drug substance and drug product
• Generate tech transfer package to support hand-off to CDMO to produce clinical material
• Interact with CRO/CDMO team members, and other SMEs as dictated by project needs
• Ensure that work is performed following current, phase-appropriate regulatory and quality compliance requirements
• Maintain knowledge of new scientific literature directly related to GIVAX programmatic priorities

Project Management (15%)

• In collaboration with Vaccine Project Head, create and monitor experimental plans, cost estimations, schedule, and resourcing plan
• Engage with external partners and other SMEs as dictated by project needs
• Monitor key milestones, decision points, and critical path activities associated with his/her function to ensure timely achievement of project deliverables
• Identify and assess risks and roadblocks, and develop mitigation plans to address risks

Internal Affairs (15%)

• Provide support to Senior Leadership to achieve the company mission
• Interact with colleagues transparently and cooperatively, contributing to an open exchange of ideas among team members
• Ensure efficient and agile communication of key information, processes, workflows, and operational elements in various circumstances.

POSITION DETAILS

• Hands-on lab role
• Reports to the Vaccine Project Head
• Title will commiserate experience
• Location: Philadelphia, PA

EDUCATION LEVEL

• PhD in life science discipline or equivalent years’ experience required
• Authorization to work in the United States required

Basic Qualifications

• PhD in a life science discipline with >1 year of postdoctoral experience
• Scientific publications in virology
• Minimum 5 years of experience in basic research

Preferred Qualifications

• Experience working in process development for live attenuated viral vaccines
• Experience in working with infectious diseases (BSL2 or above)
• Working knowledge of virology, immunology, molecular biology, and protein chemistry
• Experience in vaccine early- and/or late-stage development and manufacturing
• Ability to work in cross-functional teams effectively and to build strong relationships with partners
• Ability to work independently and take personal initiative to complete tasks
• Strong organizational/time management skills and ability prioritize tasks
• Flexibility and willingness to support the team in execution of project goals
• Excellent written and oral communication skills, fluency in English (written and spoken)