Key Duties
Major Duties and Responsibilities
Design, execute, and optimize upstream processes for virus propagation and recombinant protein expression, primarily using mammalian cell culture, from laboratory-scale vessels through rocking and stirred-tank bioreactors.
Develop scalable seed-train and production workflows, including cell-line and host-cell selection, culture expansion, inoculation strategy, media and feed optimization, process monitoring, harvest timing, and primary recovery.
Develop and optimize viral production processes by evaluating host-cell performance, multiplicity of infection, infection conditions, harvest criteria, clarification, formulation, storage, and stability.
Develop robust mammalian expression processes for recombinant proteins and antibodies using adherent or suspension culture; support insect-cell, yeast, hybridoma, or other expression platforms when required by the project.
Apply risk-based experimental design and appropriate statistical tools to identify and characterize critical process parameters and their effects on yield, productivity, product quality, and process reproducibility.
Develop and characterize workflows for maintaining cell lines, cell banks, virus seed stocks, and virus banks, including propagation, storage, stability, documentation, and traceability.
Establish and use fit-for-purpose in-process and characterization methods for cell growth, viability, metabolites, protein expression, viral concentration, infectious titer, identity, integrity, and stability.
Partner with downstream and analytical scientists to define harvest and clarification conditions that protect product quality and enable efficient purification of cell-culture-derived materials.
Troubleshoot manufacturing and product-performance issues using structured root-cause analysis; recommend and implement scientifically justified process improvements and corrective actions.
Learn and apply protein purification techniques for the purification of cell culture-derived proteins.
Plan and document experiments, analyze and interpret data, maintain complete technical records, and prepare concise reports and presentations for internal and external stakeholders.
Lead or support technology transfer of developed processes to Production and Quality Control, including transfer plans, readiness assessments, training, and on-floor support during initial manufacturing runs.
Author and revise development protocols, technical reports, SOPs, batch records, and other controlled documents in accordance with company procedures and applicable ISO 13485 requirements.
Evaluate new upstream technologies and potential custom-manufacturing projects; contribute technical scope, feasibility, resource, timeline, and cost estimates.
Maintain a safe, organized, and inspection-ready laboratory, including equipment upkeep, material management, biosafety practices, and compliance with established procedures.
Perform other duties as assigned.
Other Duties/Physical Requirements
Physical
Work is performed primarily in a laboratory environment and may involve biological materials handled under established biosafety procedures (BSL-2 and below).
Must be able to perform repetitive movements, including pipetting and computer work.
Must be able to concentrate, analyze data, and solve complex technical problems throughout the workday.
Other
Occasional work outside normal business hours, including evenings or weekends, may be required to support time-sensitive cultures, production activities, or other business needs.
Qualifications
Minimum Education or Equivalent Experirence Required/Preferred
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 demonstrated scientific track record in mammalian cell culture, virus propagation, recombinant protein expression, or upstream bioprocess development is required; experience in diagnostics, biologics, or another regulated life-science environment is preferred.
Competencies Required or Preferred
Extensive hands-on experience with mammalian cell culture to produce viruses, viral antigens, recombinant proteins, or antibodies is required.
Demonstrated experience developing and optimizing adherent and/or suspension cell-culture processes, including culture expansion, media optimization, infection or transfection, and harvest.
Working knowledge of upstream process scale-up and operation of rocking and/or stirred-tank bioreactors is strongly preferred.
Ability to design statistically sound experiments, analyze multivariable data, identify process drivers, and convert results into practical process controls and recommendations.
Experience with relevant characterization methods, such as cell growth and viability measurements, protein-expression assays, and viral infectivity assays (for example, TCID50 or plaque assays), is preferred.
Understanding of cell-bank and virus-bank lifecycle management, aseptic technique, contamination control, and biosafety practices.
Ability to learn and perform downstream bioprocessing unit operations for the purification of cell culture-derived proteins.
Ability to collaborate effectively across development, manufacturing, and quality functions and to train or provide technical direction to laboratory and production personnel.
Strong organization and project-management skills, with the ability to prioritize multiple assignments and respond calmly to changing business needs.
Proficient technical writing and clear, accurate oral communication of scientific data, conclusions, risks, and recommendations.
Required Travel
Travel is minimal. Travel between business units, travel to scientific meetings, or travel for commercial meetings may be required.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*
