BlueNalu, Inc. is a rapidly growing, San Diego-based company that is pioneering the production of seafood products derived directly from fish cells. Using proprietary cell biology techniques and engineering processes, BlueNalu's platform technology can produce a wide array of value-added seafood products, that are healthy for people, humane for sea life, and sustainable for our planet. Our products will be great tasting, trusted, safe, and free of mercury and environmental contaminants. BlueNalu has achieved considerable strategic, technical and operational milestones since its formal launch over two years ago, and it is now preparing for regulatory clearance and market launch in the US, that are both anticipated to occur during the second half of 2021.
As the Senior Bioprocess Engineer, you will be responsible for development of new high-yield cell
culture systems and improvement of existing bioprocessing technologies towards large-scale
cellular aquaculture. You will demonstrate strong bioprocess development and scale-up skills to achieve BlueNalu's company objectives. This position's initial focus will be on development and demonstration of bioprocess in pilot-scale. Duties will include bioprocess development and scale-up, bioreactor operations & maintenance at pilot scale, cell cultures, development of downstream processing techniques for cell recovery, data acquisition, processing, analysis and presentation.
- Evaluate new and existing bioprocess technologies, methods, and equipment with emphasis on scale-up and optimization of cell culture.
- Serve as a team lead in executing and optimizing pilot-scale cell culture as well as development and optimization of cell recovery systems.
- Lead technology transfer of optimal processes towards operations and pilot manufacturing and assist in training of technical operators.
- Create design specifications for bioreactor and other processing equipment.
- Serve as a subject matter expert in current state-of-art pilot- and large-scale cell culture processes and cell recovery systems.
- Create and follow Standard Operating Procedures and adhere to all safety and company policies.
- Adoption of flexible schedules and some weekend work may be required to maintain project timelines.
Supervises (by title):
- Bioreactor Operator (Pilot Scale)
- Media Operator (Pilot Scale)
Travel: Estimated at None
Minimum Qualifications & Experience
- Education and Experience:
- BS or MS in Chemical or Biochemical Engineering, Biotechnology, or equivalent with 6+ years of experience.
- Experience with bioreactors and cell culture in a pilot processing environment is a must.
- Some proven supervisory and bioreactor design experience is required.
Knowledge, Skills and Abilities:
- Demonstrated expertise with scale-up of cell culture processes using bioreactor systems as well as aseptic cell recovery systems.
- Efficient design of experiments (DOE) and statistical analysis of experimental and characterization/validation data.
- Understanding of aseptic techniques and control of microbial contamination and experience with working in GMP environment.
- Experience with generation of bioreactor designs and process flow diagrams for manufacturing operations.
- Understanding of installation, commissioning and validation systems for bioreactors in a pilot plant environment.
- Hands-on experience and mechanical aptitude for troubleshooting and maintaining bioreactor hardware.
- Demonstrated ability to conceive, plan and execute engineering projects and operations.
- Ability to summarize, interpret and review experimental data with adequate computer skills for data acquisition, data management and visualization of experimental results.
- Ability to work independently and as part of a team to achieve departmental goals with ability to present to both technical and non-technical audiences.
- Attention to detail.
- Proficient with Microsoft Office (Word, Excel, Access, Outlook, PowerPoint), JMP, GraphPad Prism, data management systems, inventory management systems etc.
- Fluent in English
- Knowledge and experience with process control systems such as Emerson Delta-V, Rockwell etc.
- Experience with GMP manufacturing requirements in food and/or pharmaceutical industries.
- Experience with steam-in-place and clean-in-place operations in stainless steel bioreactors
Materials and Equipment Directly Used
- Uses bench-scale and pilot-scale single-use and stainless steel media preparation, bioreactor and solid-liquid separation (such as centrifuges, filtration etc.)
- Microsoft Office Suite, JMP, GraphPad, data managers and other computer systems.
- Uses basic cell-culture laboratory equipment
Working Environment / Physical Demands
The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Ability to lift up to 40lbs.
- Must understand vague and implicit instructions and react favorably in all work situations.
- Must be mentally adaptable and flexible in dealing with a variety of people.
- Emotional stability and personal maturity are important attributes in this position.
- Must be able to resolve problems, handle conflict and make decisions under pressure.
- Ability to give, to receive, and analyze information, formulate work plans and prepare written materials and articulate goals and action plans.
- Must understand people and be able to communicate effectively.
- Ability to work with and directly handle products containing Major US Allergens and sensitizing agents such as fish, soy, and shellfish.
- Experience working in GMP environments.
BlueNalu, Inc. provides an attractive compensation and benefits package. All applicants must be authorized to work in the US, and willing and able to work a flexible work schedule to meet the needs of the Company. BlueNalu is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
This is an excellent opportunity to join a small but quickly growing company where everybody's contribution is equally important. BlueNalu is seeking team players that are driven, focused, creative, proactive and productive, with excellent written and verbal communication skills, and excellent interpersonal and organizational skills. We are also seeking team members that enjoy and thrive in the atmosphere of a very fast-paced entrepreneurial environment, have a good sense of humor, and are personally motivated to make a difference to humanity and our planet.
Additional information about BlueNalu can be found on our website at www.bluenalu.com