Principal Scientist / Associate Director, Downstream Process Development

Position Summary:

We are looking for a talented & driven downstream development principal scientist or associate director to play a key role in the development and execution of downstream processes & formulations 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 principal scientist or associate director will also be responsible for supervising scientists & research associates in downstream process development and formulation studies. Level will be commensurate with experience.

Key Responsibilities:

• 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 an 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 (less than 5% of time)
• 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.
• Be accountable for timelines and deliverables to management and outside stakeholders
• Perform formulation studies using DOE & statistical modeling for high concentration protein products
• Evaluate new equipment capabilities and technologies to improve upon existing processes and increase internal capabilities. Install and maintain equipment as needed.
• For associate director level, duties will also include downstream group management, group budgeting, data presentations to senior management, vendor management, and day-to-day laboratory management
• For principal scientist level, duties will include paramount technical expertise, including leading projects, interfacing with CMO’s, and driving program results and strategy

Qualifications:

• PhD in chemical engineering, life sciences, or similar fields with 8+ years of experience in downstream process development and optimization. Experience working closely with upstream colleagues. Associate Director: Leadership/management experience.
• Persons with MS/BS degree who have comparable depth and breadth of training and experience, and meet job-specific criteria are eligible for consideration
• 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.

The anticipated salary range for the position of Principal Scientist/Associate Director, Downstream & Formulation based in our Menlo Park, CA office is $159,750 to $181,250 (Principal Scientist); $176,800 to $200,400 (Associate Director).  The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc.  Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state federal and local laws regarding pay practices.