Job Description
Job Summary:
- We are looking for a candidate with experience in AAV and/or non-viral purification development, scale-up and manufacturing, and technology transfer.
Duties and 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:
- Master’s degree in biological sciences or related discipline, or Bachelor’s degree with a minimum of 2 years of relevant experience.
- 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.
Experience, knowledge and understanding of purification technologies and operations such as:
- Depth filtration
- AKTA or automated protein purification chromatography
- Tangential flow filtration or UF/DF
- Virus clearance and inactivation
- Filtration unit operations at various scales
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.