Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $190M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.
We are looking for a talented & driven downstream development scientist to play a key role in the development and execution of upstream processes for Synthekine’s various drug candidates. Expression systems may be either microbial or mammalian. The successful candidate will show an aptitude and affinity for developing and driving forward highly robust protein purification processes, from research candidates through large scale manufacturing. The downstream process development scientist may also be responsible for mentoring junior scientists/research associates. Level will be commensurate with experience.
- Establish and develop processes from research to clinical and large-scale manufacturing for all aspects of the purification process including (but not limited to): resin screening studies, filtration studies, formulation optimization studies, DOE, protein refolding studies, etc.
- Assess the impact of process parameters on product performance, establish optimal parameters and controls, and execute phase appropriate process characterization experiments with considerations on upstream and downstream process impacts.
- Troubleshoot/SME/CMO’s - Serve as the SME internally and with CMO’s to lead troubleshooting of equipment and processes. Oversee tech transfers and travel to CMO’s to monitor production runs as needed.
- Analyze data and prepare presentations, data graphs, technical reports, and regulatory documents to support process related decision making and actively engage in scientific and technical discussions to support the decision.
- Evaluate new equipment capabilities and technologies to improve upon existing processes and increase internal capabilities. Install and maintain equipment as needed.
- Coach, mentor, and develop junior team members.
- PhD in Engineering, Biotechnology, or Life Science discipline with up to 2 or more years of downstream process development experience OR
- Master’s Degree in Engineering, Biotechnology, or Life Science discipline with 4 or more years of downstream process development experience
- Bachelor’s degree in Engineering, Biotechnology, or Life Science discipline with 6 or more years of downstream process development experience
- Demonstrated practical and theoretical expertise in resin screening studies, filtration studies, formulation optimization studies, protein refolding studies, etc. SME in entire downstream theory & application
- Thorough understanding of the end-to-end manufacturing process and how changes to one part of the process can have upstream or downstream impacts.
- Experience working with CMO’s and managing tech transfers.
- Working knowledge of GMP, ISO, DOE, and QBD principles. Familiar with FDA requirements.
- Experience with technical writing: tech transfer documents, development reports, batch records, agency submission documents
- Ability to think critically, analytically and to have strong troubleshooting and problem-solving skills based on deductive reasoning.
- Self-motivated with the ability to work independently and collaboratively in cross functional teams
- Excellent interpersonal, verbal and written communication skills
- Strong ability to manage ambiguity and thrive in startup environments to build and establish new facilities, teams, and processes
- Passion for coaching and teaching. Interested in building a team.
Please apply at firstname.lastname@example.org.
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.