Our client is seeking an experienced, highly motivated Scientist to advance downstream process development for their genetic medicines.
- Develop a technical plan for laboratory studies to enable a scalable downstream process for the purification
- Perform in-house experiments and supervise efforts related to the development of downstream process steps including cell harvest, lysis, depth filtration, chromatography steps (IEX, affinity, mixed mode, etc.), viral filtration, and UFDF.
- Orchestrate runs of the established process and enable scale-up manufacturing process at contract manufacturing organization (CMO)
- Collaborate with contract research organizations to assist external development efforts
- Assist in the generation and review of protocols, reports, and batch records
- Prepare, analyze, and present data internally to cross functional teams
- MS or PhD in Biochemistry, Bioengineering, Biotechnology or related discipline
- Minimum 10 years with MS or 5 years with PhD of relevant industry experience
- Experience in working with an oligonucleotide-based purification process
- Experience in PD and manufacturing activities in a GMP environment
- Results-driven with excellent attention to details
- Ability to manage multiple projects and responsibilities simultaneously
- Proven ability to work independently, effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines
- Ability to work with others to troubleshoot complex technical and scientific problems while showing independence in execution and thought processes.
- Previous experience managing in-house and CRO work preferred
- Articulate and confident communication and interpersonal skills
- Ability to diversify technical skill sets in a fast-paced organization