Microbial Fermentation Technical Leader
Provides technical leadership in microbial fermentation and bioprocess operations. This role involves a specialized focus on optimizing microbial fermentation and managing critical downstream process operations in a Contract Manufacturing Organization (CMO) environment.
Essential functions, included but not limited to:
- Provide technical subject matter expertise (SME) to support various site operations and ensure seamless production cycles.
- Collaborate cross-functionally to refine and optimize enzyme fermentation and downstream processing (DSP) workflows to improve yield and scalability.
- Hands-on operation of core bioprocessing systems, including large-scale fermentation vessels, chromatography skids, TFF/filtration units, and lyophilization equipment.
- Act as the primary technical resource for resolving complex process deviations and equipment malfunctions.
- Assist with the calibration and routine servicing of precision production instrumentation.
- Assist in the revision of Standard Operation Procedures (SOPs) and technical documentation to maintain high quality standards and audit readiness.
- Serve as the primary technical point of contact for external clients, effectively communicating process data, technical decision-making, and site-specific capabilities in a Contract Development and Manufacturing Organization (CDMO) setting.
- Define and lead the site-wide strategy for process and equipment validation (IQ/OQ/PQ), ensuring all systems meet rigorous operational standards.
- Design and implement PM programs for critical bioprocessing hardware to minimize downtime and extend equipment lifecycle.
- Ensure all activities strictly adhere to Company policies, cGMP guidelines, internal Standard Operating Procedures (SOPs), and the site's Quality Management System (QMS).
Other functions:
- Ensure compliance with safety regulations and procedures are implemented and followed; maintain clean and safe work area.
- Assist as needed in other areas of the company where training requirements have been completed.
- Perform other duties as assigned.
Supervisory responsibilities: None.
Travel: None.
Requirements:
Required qualifications:
- Legally authorized to work in the United States.
- Bachelor of Science degree in an Engineering discipline (Chemical, Biochemical, Bioengineering, or Electrical) or a related Life Sciences field (Biotechnology, Biology, Chemistry).
- At least 2 years of hands-on experience in industrial bioprocessing or a related manufacturing field, with a proven track record of supporting production-scale operations.
- Demonstrated ability to operate within a highly regulated environment, ensuring all engineering activities maintain strict adherence to cGMP and ISO compliance requirements.
- Physically and technically capable of working with a variety of chemical reagents and biological materials (e.g., microbial cultures, enzymes) required for fermentation and downstream processing.
- Flexibility to work some limited off-shift and weekend hours in order to support all production shifts when needed.
- Strong mechanical aptitude with the ability to diagnose, disassemble, and repair complex bioprocessing hardware and fluid-handling systems.
Preferred qualifications:
- Functional understanding of automated bioprocessing platforms; able to navigate HMI (Human Machine Interface) software to monitor, control, and optimize fermentation and DSP sequences.
- Industrial plant experience with a specific focus on process scale-up, troubleshooting, and continuous improvement (CI) initiatives.
Basic skills and abilities:
- Project a positive company image by interacting with fellow employees, customers, and management in a cooperative, supportive, and courteous manner; displays a professional attitude.
- Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm.
- Ability to work independently and as a member of various teams and committees.
- Detail oriented with a high level of accuracy, efficiency, and accountability.
- Strong organizational skills to meet goals and set priorities.
- Proactively identify problems and develop solutions to improve manufacturing operations and safety.
- Participate in cost-saving initiatives and maintain or improve product quality and yield.
- Proficient in MS Office Suite.
- Ability to operate related office equipment, such as computer, calculator, and copier.
Reasoning abilities:
- Ability to apply logic and common sense understanding to carry out instructions furnished in written, oral, or diagram form.
- Ability to define problems, collect data, establish facts, and draw valid conclusions.
Language skills:
- Ability to read and interpret work related documents, procedures, and manuals.
- Ability to communicate effectively; good written and oral communication skills; ability to read, write, speak, and understand the English language.
- Good interpersonal skills such as ability to communicate effectively, internally, and externally at all levels and diverse personalities.
Mathematical skills:
- Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
- General knowledge of the metric system units (length, area, volume, capacity, mass, and weight) and U.S. equivalents.
Visual acuity:
- Close visual acuity to perform an activity such as preparing and analyzing data, transcribing, viewing a computer terminal, and reading.
Physical demands:
- Must be able to wear and work in personnel protective equipment (PPE) as required.
- Light physical activity performing non-strenuous daily activities of a primarily administrative nature.
- Stationary position sitting for prolonged periods of time while utilizing standard office tools.
- Constant repetitive motions that may include the wrists, hands and/or fingers to operate keyboard and mouse; dexterity and coordination necessary to handle files and single pieces of paper.
- The ability to hear, understand, and distinguish speech.
- Frequently communicate information and ideas with others to exchange information and understanding. Able to exchange accurate information in these situations.
- Frequently lift and/or move up to 50 pounds.
- Frequently reaching for items above and below desk level.
- Occasionally required to climb or balance; squat, stoop, kneel, or crouch.
Environment conditions:
- Well, lit, heated/air-conditioned indoor office setting with adequate ventilation.
- The noise level in the work environment is moderate.
- Periodic exposure to low temperatures in controlled refrigerators and/or freezers.
- Periodic exposure to high temperatures may occur when working with specific pieces of equipment.
- Some exposure to hazards or physical risks which require following basic safety precautions.