Scientist/Senior Scientist, Downstream Process Development
Under the direction of the Associate Director of Downstream Process Development, the Scientist/Senior Scientist is responsible for the development, optimization, characterization and scale-up of GMP-compliant manufacturing processes for recombinant Viral Vectors and supporting their transfer to clinical manufacturing sites. This position requires broad scientific understanding and hands-on execution of a variety of downstream (harvest and purification) unit operations. The successful candidate is expected to work independently on assigned tasks/projects, communicate results to management and the CMC (Chemistry Manufacturing Control) team, and prioritize assignments to meet departmental goals.
• Elements of Process Validation (PV) per Quality by Design (QbD): Process Design (commercial process development and characterization), Process Performance Qualification (PPQ); Continued Process Verification (CPV).
• Detailed experimental planning for the development of process (not only individual unit operations), execution and analysis.
• Support tech transfers with review of study plans, process descriptions, person-in-plant, data analysis, etc.
• Design of labs and equipment lay-out.
• Equipment qualification, maintenance and calibration.
• Electronic lab notebook systems.
• Viral clearance studies.
• Management of scientists (in addition to daily supervision): coaching, performance reviews, career development.
• External publications and presentations.
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) in downstream process development experience.
• Project management, ability to prioritize.
• Strong verbal and written communication skills.
• Supervision including training of scientists.
• Scientific understanding of and hands-on experience with a variety of downstream unit operations, including but not limited to:
o Chromatography (ion exchange, hydrophobic interaction, mixed mode, affinity, etc.), and
o Filtration (depth filters for clarification, membranes in normal flow (NF) and Tangential Flow Filtration (TFF).
o Lysis/extraction with detergents, use of surfactants.
• Excellent record keeping in laboratory notebooks, and authoring of procedures, protocols, technical reports and presentations.
• Hands-on experience with the operation of AKTA series of chromatography skids.
• Scientific understanding and hands-on experience with HPLC, spectrophotometry, SDS-PAGE.
• Quality Target Product Profile (QTPP) and Critical Quality Attributes (CQAs).
• Manufacturing process risk assessments.
• Statistics including tolerance intervals, practical significance tests (e.g. Two One Sided T tests), design and analysis of DOEs (e.g. with JMP), process monitoring (control charting).
• In-process analytical control strategy.
• Establishing process (operational) parameter set-points and ranges (Normal Operating Ranges (NORs), Proven Acceptable Ranges (PARs).
• Change controls, deviation investigations.
• Authoring of regulatory submissions (e.g. IND, BLA) CMC sections.
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.
May supervise one or more employees
REGENXBIO is an equal employment opportunity employer. We are committed to providing equal employment opportunities to all qualified individuals without regard to the following legally protected characteristics: race, color, religion, sex, pregnancy (including childbirth, lactation and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military/veteran status, or any other characteristic protected by local, state or federal law. We assure you that your opportunity for employment with REGENXBIO depends solely on your qualifications.