Scientist/Sr. Scientist, Bioproduction

Description:

The Senior Scientist, Bioproduction position plays a key role in developing and optimizing cell culture processes related to the manufacturing of recombinant proteins in mammalian cells. This individual will work independently to optimize cell culture conditions, develop bioreactor scale up process, and identify novel technologies to enhance productivity of mammalian cells following transfection via scalable electroporation. We are seeking a flexible self-starter with the breadth of professional experience and drive to work effectively with both internal and external partners in a highly matrixed and cross-functional organization.

Job Responsibilities:

• Performs and analyzes Design of Experiment (DoE) studies to ensure consistent, high-yielding mammalian cell culture processes for transient expression of recombinant proteins and other biologics in mammalian cells
• Optimizes mammalian cell culture parameters, bioreactor optimization and scale up process from Ambr 250 to 50L bioreactors, and media & feed optimizations
• Transcribe Process Development reports into working Batch Records for cGMP productions
• Maintains up to date knowledge of manufacturing trends and provides recommendations regarding manufacturing process improvement initiatives
• Identifies and integrates cell culture and analytical technologies that synergize with GMP-compliant, scalable electroporation instrumentation
• Contributes to cross-departmental activities as needed, by providing technical input where required
• Prepares and reviews technical documents for patent applications, regulatory authorities and external contractors and collaborators
• Develops, revises, and reviews SOPs, protocols, process development and technical reports
• Maintains appropriate level of documentation throughout the entire development process and follows Good Documentation Practices
• Collaborates and manages relationships with cross functional internal and external stakeholders including Research and Development (R&D), Manufacturing Operations, Engineering (ENG) Quality Assurance (QA) and Sales and Marketing (S&M)
• Complies with all applicable laws and Company policies regarding health, safety, and environment

Requirements:

• Requires PhD in cell biology, biotechnology, chemical engineering, or related field and at least 8-10 years of experience in the biopharmaceutical industry or equivalent
• Excellent understanding of mammalian cell biology, metabolism, and bioreactor optimizations
• Ability to operate development and pilot scale equipment, including shake flasks, Ambr250, bench-scale stirred tank bioreactors and rocking bioreactors plus knowledge of scale up and technology transfer from lab scale to pilot scale (50 to 200L)
• Strong background in statistics including data analysis in software like JMP is highly desired
• Extensive experience in media and feed optimization and metabolite analysis
• Experience with transient transfection of mammalian cell lines, including CHO, HEK and Vero cells
• Experience with AAV, lentivirus and VLP production is a plus
• Experience with CHO cell engineering and cell line development is a plus
• Hands-on experience with analytical instrumentation for measuring cellular metabolites, media composition and recombinant protein concentrations
• Working knowledge of test methods, such as qRT-PCR, flow cytometry, ELISA and immunological assays
• Ability to independently conceive experimental designs, make detailed observations, analyze and interpret data, propose improvements to and troubleshoot experimental protocols
• Strong quantitative, qualitative, and critical thinking skills and abilities
• Ability to adapt to changing needs as experiments develop or priorities change
• Strong troubleshooting skills with the ability to “think outside the box”.
• Strong written and oral communication skills are essential; ability to present thoughts clearly and concisely
• Detail oriented with strong organization and project management capabilities
• Ability to effectively collaborate with and lead vendors, customers, colleagues, and direct reports across teams
• Demonstrated computer skills; experience using MS Office and other data analysis software and other related applications

Note: To the extent permissible under applicable law, candidates will be required to show proof of being fully vaccinated against COVID-19 upon commencing employment. Reasonable accommodations will be considered on a case-by-case basis for exemptions to this requirement in accordance with applicable law.