The Scientist II will assist in the development and licensure of viral, bacterial, parasitic and/or recombinant vaccines as well as new label claims or product improvement research of the licensed vaccines.
Responsibilities and Key Duties:
Obtaining USDA Licenses and/or Claims
- Conduct, plan, coordinate and assist Project Leader with all R&D activities to meet timelines of new viral, bacterial, parasitic and/or recombinant vaccines per USDA CVB licensing procedures. Activities include but are not limited to:
o Conducting independent research projects as assigned by Project Leader
o Utilizing project management programs to monitor R&D project timelines; assist in identifying targeted label wording
o Assisting in seed isolate evaluation, selection, preparation and transfer to Quality Assurance department
o Contributing to adjuvant selection and preparation of emulsions; develop disease challenge models
o Conducting vaccine feasibility and efficacy studies
o Conducting data analysis
o Develop and transfer antigen production procedures
o Assist in development, validation and transfer of test procedures (antigen in-process assays, inactivation assurance tests, final product potency tests, and antigen and product stability assays)
o Communication with the USDA and CROs on project specific matters
- Extend pre-existing label claims for licensed products
- Assign work to lab technicians as required to meet timelines
- Supervise the propagation of viral, bacterial and/or recombinant stocks, performance of titrations and biological and/or molecular assays
- Plan and participate in animal trials and necropsy
- Plan and participate in executing small R&D projects and/or portions of large R&D projects
- Write drafts of USDA protocols and reports
- Contribute to Research and Development monthly reports
- Write drafts of USDA protocols and reports, assemble data and records and prepare data for analysis
- Identify and evaluate novel technologies including literature and patent searches as it pertains to vaccine research and development
Team Work with other R&D groups, Production Departments and Scientific Support/Product Support Personnel
- Primary involvement in transfer and training of projects and new technology to Production, Quality Control and other departments as appropriate
- Lead projects related to Research and Development/Industrial Operations (RADIO) and/or Scientific Support/Product Support
- Create training and/or reporting materials and provide training to R&D employees as well as other internal departments as appropriate
- Communicate with and provide technical input to Regulatory Affairs on assigned submissions and projects as requested
- Communicate on project related matters with both internal and external partners, including meeting updates at corporate meetings, regulatory agencies and CROs as needed
- USDA Regulations, Documentation and Internal Quality Assurance
- Maintain complete and accurate bench records for each project
- Review bench and study records of others
- Comply with USDA Regulations
- Contribute to, write and review SOPs, bench record forms, Outlines of Production and Special Outlines
Laboratory Maintenance
- Lead or assist with multiple intra- and inter-departmental activities including the following: weekly team meetings, common/shared labs, timeline(s), intra/inter-departmental issue(s), biosafety and transfer projects
- Mentor and develop junior colleagues within the department
- Ensure that laboratory personnel are trained about and adhere to appropriate safety requirements, equipment operation, laboratory maintenance and study protocols
- By audit, ensure that laboratory notebook records and document keeping are in compliance with the USDA CVB guidelines
Professional and Scientific Development
- Maintain and establish collaborations with outside (academic and research) institutions for potential sources of new reagents, pathogen isolates, technologies for new disease models and assays
- Attend professional and scientific meetings to stay up to date on science, technology and innovations
- Assist in writing and publishing scientific papers and/or patent applications
- Deliver scientific presentations at professional meetings to bolster and promote company products
- Actively interact with Ceva international groups on global projects, information exchange and expertise/knowledge sharing
Core Competencies and Attitudinal Characteristics:
- Shape solutions out of complexity - Work to evolve immediate environment
- Client focus - Make sure needs and requests are treated equally and in a positive way
- Collaborate with empathy - Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions taken
- Engage and develop - Open to share knowledge and to receive feedback from others
- Drive ambition and accountability - Ensure accuracy of work the use of KPI's and a responsible commitment
- Influence others - Show structure and confidence while speaking
Technical / Functional Competencies:
- Technical writing experience (USDA report, protocol and research reports)
- Strong data analysis and statistics skills
- Microsoft Word, Excel, Bioinformatics
- Time management, prioritization and planning skills with demonstrated ability to execute on multiple projects simultaneously
- Strong ability to work independently with minimal supervision
- Excellent communication, presentation, collaboration and organizational skills
Education – Ph.D. and/or DVM in Microbiology or Biology or equivalent, with 2 years of experience
o Or
- Masters in Microbiology or Biology or equivalent, with 5 years of relevant experience
o Or
- BA/BS in Microbiology or Biology or equivalent, with 8 years of relevant experience
Work Experience –
- Advanced knowledge in microbiology, chemistry, virology, bacteriology, parasitology, immunology, vaccinology and/or molecular biology
- Advanced knowledge with molecular biology techniques
- Experience in assay development and validation (e.g. PCR, antibody/antigen ELISA and Western blot)
- Experience in USDA CVB commercial licensing procedures
- Experience in animal disease model development
- Experience in veterinary biological development
- Experience with Flow Cytometry
- Other (consider certifications, specialized knowledge and/or training, etc.) – 9 CFR, USDA Vet. Memorandum 800s, SAM, CVB Notices; experience with tissue culture; knowledge of specific animal infectious diseases, animal and laboratory study designs and data analysis; Biosafety in Microbiological and Biomedical Laboratories (BMBL)
- Ability to read, write legibly and understand English
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This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.