Senior Biomanufacturing Engineer

Precise Systems, Inc.•Edgewood, MD

26d•$77,571 - $120,357

About The Position

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.

Requirements

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.
Must be able to obtain and maintain a Secret security clearance.
U.S. Citizenship is required.

Nice To Haves

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.
Translation of bench methods to pilot scale systems, analytical chemistry data analysis and interpretation, and familiarity working in hazardous rated environments is a plus.

Responsibilities

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