Scientist I

Position Overview/Department Description
The Genomic Medicine Unit (GMU) in *** is responsible for the design and optimization of cell and gene therapy manufacturing processes and platforms. This organization encompasses vector and cell line engineering, upstream and downstream process development, drug product development, analytics, and clinical manufacturing support.

The GMU purification process development group is responsible for the development of viral and non-viral gene therapy purification processes and supporting gene therapy purification for next-generation production platforms to enable high-dose gene therapy programs. The Scientist - Purification Process Development role requires leadership both inside and outside the laboratory and will rely on industry expertise and the exploration of Client technologies in order to build robust and efficient purification processes.

We are looking for a candidate with experience in biologics or gene therapy purification development and bioprocess analytics.

Key Responsibilities:
• Lead and conduct viral/non-viral vector purification process development and process analytics
• Develop and optimize robust viral/non-viral vector purification process using advanced knowledge of column chromatography, filtration, and other downstream purification technology
• Develop, conduct, maintain analytical assays such as ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS etc. for in-process sample testing to support process development
• Provide scientific and technical expertise for in-process sample testing activities, including product quality and process impurity methodologies
• Perform troubleshooting experiments and communicate findings with appropriate working groups
• Maintain industry knowledge and keep abreast of new and relevant technologies
• Perform data analysis, contribute to technical reports, external publications, patent applications and internal/external presentations
• Lead scale-up activities to implement a manufacturing process based on DSP development knowledge
• Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
• Mentor and support junior staff and build a culture of support and collaboration

Basic Qualifications

• PhD in Biotechnology, Biochemistry, Chemical Engineering or related discipline or master's degree with a minimum of 4 years of relevant experience or a bachelor's degree with a minimum of 6 years of relevant experience
• Technical experience in modern analytical techniques such as spectrophotometry, ELISA, DLS, Octet, QPCR/ddPCR, HPLC, and CE-SDS
• Significant experience, knowledge and understanding of purification technologies and operations such as:
o Filtration unit operations at various scales, including depth filtration, tangential flow filtration, etc.
o Protein purification chromatography
o Virus clearance and inactivation
• Familiarity with advanced purification technologies and process analytical technologies
• Familiarity with analytical method transfer, analytical method bridging across organizations
• Experience with process technology transfers and performing gap analyses and risk assessments
• Understanding of critical quality attributes and the principles of Quality by Design and ability to apply DOE to downstream development
• Expertise in technical report writing

Preferred Qualifications
• Experience in AAV and/or non-viral purification development
• Experience in writing CMC components of regulatory dossiers
• Knowledge of product comparability, target product profile and quality risk assessment activities
• Viral clearance study design and execution
• Late-stage purification experience such as design space mapping and process robustness studies
• Ability to work in Biosafety Level 2, follow safe lab procedures and maintain good laboratory practices (GLPs)
• Ability to work under minimal supervision and function within a collaborative, team-oriented environment
• Excellent organization and communication skills
• Innovative, critical and creative thinker, unafraid of proposing aggressive solutions to complex problems
• Experience with biophysical characterization
• Experience in continuous manufacturing and process analytical technology
• Experience in mentoring junior staff
• Ability to build and nurture cross-functional relationships
• Ability to communicate and represent group in diverse, multi-functional meetings