Job Description

Precise Systems is seeking to hire a Senior Biomanufacturing Engineer with advanced experiences in downstream processing such as distillation, liquid-liquid extraction, chromatography, and/or other chemical engineering processing unit operations to lead biomanufacturing projects. The candidate should have a well-demonstrated record in the process development, production, and characterization of molecule manufacturing from small molecule biochemicals to solid biomaterial products. Experience with operation of pilot-scale chemical processing equipment or large-scale chemical manufacturing is a must. Translation of bench methods to pilot scale systems, analytical chemistry data analysis and interpretation, and familiarity working in hazardous rated environments is a plus.

The candidate will be leading efforts with heavy emphasis on pilot-scale biochemical recovery from fermentation broth as part of a pipeline development team who makes kilogram-scale volumes of various biochemicals and biomaterials for prototyping efforts. Therefore, applicants with a willingness and desire to work collaboratively with teammates while demonstrating personal competency and meaningful creative and technical leadership will be highly favored.

Duties:

• Lead development of project-specific process improvements in the Biochemical DSP space
• Mentor/train engineers and operators on large-scale processes, equipment, and industry standards
• Balance timelines, budgeting, and resources to execute projects while allowing for equipment maintenance, facility improvements, and/or process adjustments
• Ability to perform hands-on adjustments to equipment where needed, or train operators to do so
• Ability to create P&IDs with user requirement specifications for new equipment as needed
• Coordinate commissioning and site acceptance tests of new equipment as needed
• Collaboratively develop workflows to translate bench-scale downstream processes to pilot-scale operations
• Set up and execute workflows in the Biochemical DSP lab while adhering to all regulations
• Sample systems as appropriate/record process data & report on analysis of data
• Active participant in regular process development conversations with teammates and project collaborators
• Regularly share project data with teammates and collaborators to advance joint project efforts
• Participate in Tech Transfer conversations with potential collaborators (entering and exiting facility)
• Keep detailed records of laboratory operations, all process-related developments, and compile data into regular technical reports
• Update and maintain SOP documentation in the Biochemical DSP space IAW all regulations
• Maintain record logs of all operational activities IAW all regulations
• Report process developments in Invention Disclosures towards Patent Applications as appropriate

Required Experience:

• B.S. or M.S. in Chemical Engineering, Mechanical Engineering, or Biochemical Engineering or related field preferred but others will be considered depending on experience.
• 5+ years of experience in a leadership role executing pilot- or large-scale manufacturing processes.
• Experience/understanding of hazardous location operations (knowledge of NEC/NFPA regulations strongly preferred).
• Demonstrated hands-on experience in chemical processing techniques such as distillation, liquid-liquid-extraction, centrifugation, and other pilot-scale operations.
• Familiarity with industry standards and safety regulations (ASTM, ANSI, ASME, ISO, etc).
• Understand the economics of biomanufacturing and scale-up considerations.
• Must be able to lead a team to design, plan, and execute large-volume experiments/processes.
• Demonstrated leadership skills, ability to mentor and train engineers/operators and a passion for problem solving.
• Excellent oral and written communication skills.
• Able to work productively and independently in an interdisciplinary team environment.

Desired Experience:

• Project management experience and capable of managing deadlines.
• Understanding of root cause analysis (RCA), management of change (MoC) procedures, and CAPAs
• Experience with both microbial fermentation and biomaterial extraction.
• Familiarity with tools and mechanical devices, hands-on projects; willingness to turn a wrench as needed.
• Comfortable at heights and willing to climb ladders as needed.
• Creativity in identifying places where application of available novel biomaterials could solve relevant problems.

Must be able to obtain and maintain a Secret security clearance. Due to the sensitivity of customer-related requirements, U.S. Citizenship is required.

Precise Systems values employee contributions, promotes diverse opportunities for professional growth, and prioritizes overall well-being. Our comprehensive professional services benefits package includes health insurance, life and accidental death and dismemberment coverage, disability insurance, retirement plans, holiday pay, employee-managed leave, and professional growth opportunities.

We recognize exceptional performance and alignment with our core values through our STAR Award recognition program.

Compensation at Precise Systems is determined by various factors, including education, experience, skills, competencies, and contract-specific requirements. The salary range for this position is $77,571.36 to $120,357.04 (annualized USD). This range represents the standard pay for this role and is just one component of Precise Systems' total compensation package.

Precise Systems is committed to fair and equitable pay practices in alignment with applicable pay transparency laws and equal employment opportunity standards

Precise Systems is dedicated to a shared vision and core values of Integrity, Respect, and Responsibility, which foster innovation and drive our continued success in the global marketplace.