Senior Scientist, Bioproduction Process Development

Location
Gaithersburg, MD
Posted
Oct 08, 2021
Hotbed
BioCapital
Required Education
Masters Degree/MBA
Position Type
Full time

MaxCyte is a leading provider of cell-engineering platform technologies to advance innovative cell-based research, development, and commercialization of next-generation cell therapies. The company's existing customer base ranges from large biopharmaceutical companies — including 20 of the top 25 pharmaceutical companies based on 2020 global revenue — to hundreds of biotechnology companies and academic translational research centers. MaxCyte has granted 14 strategic platform licenses to commercial cell therapy developers that allow for more than 75 clinical programs. Founded in 1998, MaxCyte is headquartered in Gaithersburg, Maryland, US.

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 proteins 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

• 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, 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 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, 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 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.

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).

• 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.

• Hands-on experience with automated 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

MaxCyte, Inc. is an equal opportunity employer. To apply, please send your resume and cover letter . Please reference Bioproduction Process Development in the subject line.