• Senior Scientist, Bioproduction Process Development

Location
Gaithersburg, MD, United States
Posted
May 28, 2021
Ref
1547943636
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
About MaxCyte:

MaxCyte, the clinical - stage global cell - based therapies and life sciences company, uses its proprietary next - generation cell and gene therapies to revolutionize medical treatments and ultimately save lives. The Company's premier cell engineering enabling t echnology is currently being deployed by leading drug developers worldwide, including all of the top ten global biopharmaceutical companies. MaxCyte licences have been granted to more than 1 4 0 cell therapy programs, with more than 100 licensed for clinical use, and the Company has now entered into ten clinical/commercial license partnerships with leading cell therapy and gene editing developers. MaxCyte was founded in 1998, is listed on the London Stock Exchange (AIM:MXCT, MXCL) and is headquartered in Gait hersburg , Maryland, US. For more information, visit www.maxcyte.com .

Job Summary:

The Senior Scientist , Bioproduction Process Development position plays a key role in developing and optimizing cell culture processes related to the manufacturing of recombinant protein s in mammalian cells . This individual will work independently to optimize media formulations, integrate cell culture and processing platforms , 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:

• Supports the establishment of a PD lab, including installation of equipment and the implementation of lab SOPs
• Perform s and analyze s Design of Experiment (DOE) studies to ensure consistent, high - yielding mammalian cell culture process es for transient expression of recombinant proteins and other biologics in mammalian cells
• Op timizes mammalian cell culture parameters , including media formulations, culture supplements and bioreactor settings
• 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 department al activities as needed, by providing technical input where required. Prepares and reviews technical documents for patent applications, regulatory authorities and external contractors and collaborators
• Develop s , revise s, and review s SOPs, protocols , and 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 R esearch and Development (R&D) , Manufacturing Op erations, Engineering (ENG) Quality Assurance (QA) and Sales and Marketing (S&M) .
• C omplies with all applicable laws and Company policies regarding health, safety, and environment.

Job Requirements:

• Requires PhD in cell biology, biotechnology, chemical engineering or related field and at least 4 years of experience in the biopharmaceutical industry or a minimum of 10 years relevant experience with a master's degree
• Excellent understanding of mammalian cell biology and metabolism
• Ability to operate development and pilot scale equipment, including shake flasks, 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).
• St rong background in statistic s 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 .
• Hands - on experience with automated analytical instrumentation for measuring cellular metabolites , media composition and recombinant protein concentrations
• Working knowledge of tes t methods, such as qRT - PCR, flow cytometry, ELISA and immunological assay s
• 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 a dapt 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 MaxCyte, Inc. is an equal opportunity employer.