Scientist, Downstream Process Development

SUMMARY:

Our client is seeking an experienced, highly motivated Scientist to advance downstream process development for their genetic medicines.

RESPONSIBILITIES:

• 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

Requirements:

• 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