Scientist/Senior Scientist, Upstream Process Development - Rockville, MD | Biospace
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Scientist/Senior Scientist, Upstream Process Development

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Location:
Rockville, MD
Posted Date:
8/31/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Process Development, Scientist, Senior Scientist,

Job Description


POSITION SUMMARY

Reporting directly to the Associate Director of Upstream Process Development, the Scientist/Senior Scientist, will act as a technical lead for the development and optimization of novel cell culture and bioreactor processes for AAV production. Responsibilities range from cell line selection, Bioreactor process development, process scale-up, characterization studies, robustness studies, and authoring transfer documents for tech-transfer to the clinical manufacturing site(s). This position requires hands-on execution of process optimization, cell culture media/feeds screening, and improvements, along with process characterization of cell culture production processes that can be transferred to the Manufacturing group as well as to external collaborators.  Furthermore, this individual is expected to work independently on assigned tasks/projects, mentor junior associates, and provide insight to improve processes, and communicate results to the CMC team.  The successful candidate will prioritize assignments to meet departmental and organizational goals.

PRIMARY RESPONSIBILITIES

•   Develops scalable, robust, high yielding, and economically viable cell culture processes using miniature, bench-scale, and larger disposable bioreactors in the laboratory setting for the production of AAV vectors
•   Performs hands-on experiments to develop feed strategies using chemically defined medium and feeds
•   Designs scientifically rigorous experiments using statistical DoE where applicable
•   Executes experiments, analyzes and interprets data, to make process improvements, and further design next studies
•   Executes process monitoring and control strategies for robust process design
•   Ensures scalability of unit operations during process development
•   Collaborates and coordinates material needs with colleagues from research, downstream, analytical, and formulation groups
•   Manages, and trains junior associates on procedures and processes in the lab
•   Provides person-in-plant support for cGMP manufacturing of pre-clinical and clinical study materials
•   Authors Standard Operating Procedures, technical reports, process descriptions, including data interpretation and procedures suitable for inclusion in IND, BLA, or equivalent regulatory submission
•   Supports the execution of start-up, commissioning, and maintenance of equipment and processes
•   Reviews process descriptions and batch records during tech transfer
•   Keeps current with advances in upstream processes for viral vector production

Requirements


SKLLS, KNOWLEDGE AND ABILITIES REQUIRED

•   Ph.D. with 0-3 years for Scientist I, 3-6 years for Scientist II, and 6+ years for Senior Scientist or MS with 6+ years for Scientist I, 8+ years for Scientist II, and 10+ years for Senior Scientist, in an industrial setting, in Biological Sciences, Biotechnology, Chemical Engineering, or other related fields
•   Hands-on experience with mammalian and/or insect cell culture, aseptic techniques, understanding of biochemical engineering concepts, and biochemical pathways
•   Significant experience in developing and improving scalable fed-batch, transfection, and perfusion upstream processes in PD setting
•   Familiar with Bioreactor Scale-up concepts and have a proven record for scaling-up processes to disposable/stainless bioreactors
•   Ability to use Design of Experiments in JMP, Design Expert, or other for statistical experimental design, and data analysis
•   Knowledge of statistical process control, QbD, and PAT concepts preferred
•   Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts
•   Excellent record keeping abilities to adequately document process development data
•   Detail-oriented and able to prioritize assignments
•   Strong verbal and written communication skills and ability to communicate within the organization as well as externally
•   Able to travel as needed
•   Familiarity with FDA guidance and quality systems preferred
•   Experience in a cGMP environment preferred


TECHNICAL SKILLS

•   Familiar with bioreactor set-up, bioreactor controls, and using data historians
•   Experience with the ambr bioreactor system, and the rocker/Wave platform
•   Ability to operate disposable Bioreactors at 10L, 50L, and 200L scales
•   Familiar with good laboratory practices including equipment maintenance, and the use of biochemical analytical tools to acquire in-process data
•   Experience in viral vector or viral vaccine production preferred


WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS

Must be familiar with BSL-II lab safety requirements
Occasional travel (<20%) might be required


MANAGER/SUPERVISORY RESPONSIBILITIES

Manages up to two direct reports, coordinate their daily activities, and provide necessary support and training to carry out experimental work in the laboratory.