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

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Location:
Rockville, MD
Posted Date:
9/1/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Process Development, Scientist, Senior Scientist,

Job Description


POSITION SUMMARY

Under the direction of the Associate Director downstream process development, the Scientist/Senior Scientist is responsible for the development, optimization, and scale-up of GMP compliant downstream process for recombinant Viral Vectors. Responsibilities include development of novel and optimization of current purification processes, scale-up and transfer to clinical manufacturing sites. This position requires hands-on execution of product recovery, clarification, purification and formulation process development, as well as process scale-up and tech transfer to GMP manufacturing. The successful candidate is expected to work independently on assigned tasks/projects, provide insight to improve processes, communicate results to the CMC team and prioritize assignments to meet departmental and organizational goals.

PRIMARY RESPONSIBILITIES

•   Designs scientifically rigorous purification strategies and investigates purification parameters, including product recovery, clarification, purification and formulation; using statistical DoE for process characterization/optimization where applicable.
•   Works hands-on to develop, optimize and scale-up downstream processes using small to large scale purification systems in the laboratory setting for the purification of AAV vectors. May lead others in study execution.
•   Performs standard analytical methods to characterize biologics-HPLC, SDS-PAGE, Western Blot, spectrophotometer.
•   Designs and Executes process monitoring and control strategies for robust process design.
•   Confirms scalability of unit operations during process development and anticipates equipment related scaling issues.
•   Ensures proper documentation and reporting of experiments and results.
•   Manages project and people, trains junior associates on procedures and processes.
•   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.
•   Collaborates with upstream and assay development groups to coordinate material needs.
•   Supports the execution of start-up and commissioning of equipment and processes.
•   Reviews Process Descriptions, and Batch Records during tech transfer.
•   Keeps current with advances in downstream processes for viral vector production.

Requirements


SKILLS, KNOWLEDGE AND ABILITIES REQUIRED

•   M.S. or Ph. D in Biochemistry, Chemistry, Chemical Engineering or Biological Sciences
•   Minimum 6+ years (for MS) or 3+ years (for Ph. D) downstream process development experience, using chromatographic and non-chromatographic purification methods.
•   Hands-on experience with the operation of AKTA series of chromatography skids and current filtration technologies (Both Normal Flow Filtration and Tangential Flow Filtration) are required.  
•   Knowledgeable of cGMP manufacturing and cGMP/cGLP compliances.
•   Proven leadership in developing and improving scalable purification processes in PD settings.
•   Demonstrated scientific creativity, technical proficiency and knowledge of scientific concepts.
•   Knowledgeable with current analytical methods used for downstream assessment, and for clinical lots testing.
•   Excellent record keeping abilities to adequately document process development data.
•   Familiar with good laboratory practice and record keeping and following of protocols to acquire reproducible data; Analyze, interpret, and present data to project teams.
•   Define timeline and deliverables of downstream process development to project teams
•   Write technical reports, transfer the purification process to clinical manufacturing site, work with clinical manufacturing team to generate and review SOPs and batch record, and provide technical support for clinical material production
•   Closely work with other functional teams: analytical, cell culture, formulation, and QA
•   Design and conduct process characterization and assessment of critical process parameters
•   Support regulatory filing
•   Possess excellent interpersonal skills, supervising and management skill
•   Strong verbal and written communication skills and ability to communicate within the organization as well as externally.
•   Task & Team-oriented, analytical, organized, detail-oriented, self-motivated & ability to multitask; Ability to effectively work both independently and in a highly collaborative/team oriented R&D environment
•   Must be able to lift to 25 lbs with or without reasonable accommodations.
•   Able to travel as needed.

TECHNICAL SKILLS

•   Hands-on experience with the operation of AKTA series of chromatography skids and current filtration technologies (Both Normal Flow Filtration and Tangential Flow Filtration) are required.  
•   Experience in process optimization, risk assessment, process characterization, validation, and SOP authoring. Knowledge in statistical design of experiment and data analysis.
•   Strong verbal and written communication skills, ability to manage multiple projects simultaneously and attention to details, highly organized and self-motivated
•   HPLC, SDS-PAGE, Western Blot, spectrophotometer
•   Intermediate computer skills using MS Office (Word, Excel, Power point)
WORKING CONDITIONS AND/OR PHYSICAL REQUIREMENTS
•   Follow rules of Biological Safety Level 2 laboratories.
•   Must be able to lift to 25 lbs with or without reasonable accommodations.

MANAGER/SUPERVISORY RESPONSIBILITIES

Manage 1-2 Associate scientist(s).