Research Associate II

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

The GMU purification process development group is responsible for the development of AAV and non-viral vector processes and for supporting viral vector purification from next-generation production platforms to enable high-dose gene therapy programs. The Senior Research Associate (SRA) Downstream 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 consistent with patient safety standards.

We are looking for a candidate with experience in AAV and/or non-viral purification development, scale-up and manufacturing, and technology transfer.

Key Responsibilities:
Support to develop, design and conduct viral vector purification experiments and evaluate new technologies to increase product yield and process understanding
Develop, maintain and demonstrate advanced knowledge of principals and techniques in column chromatography and other areas of downstream purification
Maintain industry knowledge and awareness of new and relevant technologies, and be willing to publish findings and to speak both internally and externally as industry leaders
Lead / support development of study design, optimization of purification process conditions, media screening and perform troubleshooting experiments and communicate findings with appropriate working groups
Perform data analyses, contribute to technical reports and internal/external presentations
Support scale-up activities to implement a manufacturing process based on applied DSP knowledge
Communicate effectively with internal and external teams, e.g. CDMOs for tech transfer activities
Contribute to manuscript and patent writing for external publications and patent applications, respectively
Self-motivated and display sound technical judgement
Build a culture of support and collaboration among colleagues

Basic Qualifications
Masters degree in biological sciences or related discipline, or Bachelors degree with a minimum of 2 years of relevant experience
Experience, knowledge and understanding of purification technologies and operations such as:
o Depth filtration
o AKTA or automated protein purification chromatography
o Tangential flow filtration or UF/DF
o Virus clearance and inactivation
o Filtration unit operations at various scales
Strong grasp of chromatography principles and modalities
Experience with process technology transfers and performing gap analyses and risk assessments
Expertise in technical report writing
Ability to learn and perform viral vector analyses using new tools and techniques
Exhibits good laboratory practices including writing neat laboratory procedures in lab notebooks

Preferred Qualifications
Familiarity with purification of viral vectors
Knowledge of basic analytical tools such as spectrophotometry, ELISA, HPLC, and SDS-PAGE
Basic understanding of the principles of Quality by Design and ability to apply DOE to downstream development
Understanding of viral clearance study design and execution strategy preferred
Experience with large-scale unit operations
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
Ability to build and nurture cross-functional relationships
Ability to communicate and represent group in diverse, multi-functional meetings
Ability to stand and work with lab bench equipment in laboratory