Scientist, Upstream Process Development
Employment Type : Full-Time
About Meridian: Meridian Life Science, a segment of Meridian Bioscience, is a first-choice solution provider of innovative immunological and molecular raw materials that accelerate discovery and diagnostic assay development. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, novel solutions to tough problems.Job Summary:Position Purpose:The Scientist, Upstream Process Development position will provide hands-on technical guidance within our Technical Operations and Development department to drive the improvement and growth of our immunological reagent offerings including recombinant proteins, native/viral antigens, monoclonal antibodies, polyclonal antibodies, blockers, and custom manufacturing. This position is responsible for leading the optimization and scale up of processes, troubleshooting manufacturing issues, improving product quality, and reducing manufacturing costs. The role will be responsible for conducting research and manufacturing related to tissue culture, virus propagation, virus characterization, insect protein expression, mammalian protein expression, and harvest unit operations. The position will be required to work independently at the bench as well as effectively collaborate through communication of scientific findings to internal and external groups. The job function requires sound scientific judgment and innovation using advanced practices and procedures to achieve solutions.Key Duties:Relationships:- The position will collaborate with Technical Operations and Development to design experiments, execute experiments, and analyze generated data for assigned projects. The position will collaborate with various groups including quality and manufacturing to complete both development projects and assigned custom manufacturing.
- The position will interact with both internal and external contacts. The position will present scientific findings to the appropriate managerial teams. The position will be responsible for communicating with custom manufacturing clients regarding progress and technical issues.
- The position reports to Manager, Technical Operations and Development.
- The position can be an independent contributor or manage Senior Research Associates and Research Associates as assigned.
- The direct reports for this position, if applicable, will be individual contributors.
Responsibilities Include:- Collaborate within multidisciplinary development and operational teams to develop and optimize upstream processes for protein expression and virus propagation, scale-up upstream processes from flasks to bioreactors, and manufacture custom products.
- Develop and characterize work flow for cell line, cell bank, virus, and virus bank maintenance. This includes growth, propagation, formulation, storage, and stability procedures.
- Develop and optimize virus upstream production procedures including cell culture optimization, multiplicity of infection studies, harvest optimization, and storage.
- Develop robust, scalable, highly productive upstream processes for mammalian and insect expression of recombinant proteins including antibodies in WAVE and stir tank bioreactors.
- Optimize and scale up protein expression through construct design, understanding of cell culture parameters, understanding of expression parameters, and media optimization.
- Develop and perform virus characterization assays/procedures to analyze concentration, infectious titer, integrity, and stability to be implemented early in the virus production workflow.
- Develop or optimize analytical methods to determine the expression levels and quality of the expressed protein to be used prior to purification unit operations.
- Document and manage experimental methods and results. Prepare routine technical progress reports to be shared at internal and external meetings.
- Assist to identify new technologies for upstream bioprocessing and characterization of recombinant proteins and viruses.
- Lead technical transfer of developed procedures to production and/or quality personnel. Includes development of batch records, design of transfer plan, and execution of transfer plan including boots on the ground training.
- Author batch records and SOPs for transferred/developed processes in compliance with current ISO13485 regulations and company SOPs.
- Assist reviewing potential custom manufacturing projects, summarizing scope of work, and providing estimated costs required to complete scope of work.
- Perform routine laboratory maintenance and management including ordering of materials, cleaning and maintenance of laboratory equipment, etc.
- Other tasks as assigned.
Qualifications:
Knowledge, Skills and Abilities- Extensive hands on experience with tissue culture, protein expression, and virus propagation required. Experience with rocking or stirred bioreactors preferred.
- Working knowledge of upstream process scale up and optimization preferred.
- Demonstrated ability to analyse and characterize biomolecules through projects or publication records. Experience with virus infectious titre assays such as TCID50 or plaque assays preferred.
- Demonstrated ability to design, document, and execute experiments. Must be able to accurately analyse and interpret generated results.
- Work effectively in collaborative environment, communicate scientific findings freely, and instruct/ train personnel as required.
- Open to learn and develop new techniques to support the development and improvement of immunological IVD reagents.
- Well-organized, able to manage multiple projects, calm under pressure.
- Proficient in technical writing, concise and accurate oral and written reporting of technical data.
Education and Experience:- A Bachelors, Masters, or Ph.D. from an accredited institution in a relevant scientific discipline such as Virology, Biochemistry, Molecular Biology, etc. is required.
- Required is 10+ years of relevant research or industrial experience with a bachelors, 8+ years with a Masters, or 0-2+ years with a Ph.D.
- A proven scientific track record with research related to virus propagation, protein expression, or upstream bioprocessing.
Requirements:
- Travel is minimal. Travel between business units, travel to scientific meetings, or travel for commercial meetings may be required.
- Primary work requirements include working in a laboratory setting.
- Must be able to perform repetitive movements including pipetting and typing.
- Ability to concentrate, analyze, and solve complex issue throughout the day.