Senior-Principal Bioprocess Engineer, Scale-Up And Manufacturing

BlueNalu, Inc. is a fast-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 animals, and sustainable for

the planet.

Job Summary:

The core responsibility of this position is to set technical direction and manage execution of pilotscale

cell-culture process development and further scale-up efforts towards manufacturing. This

role will focus on understanding the key technologies, raw materials, and process needs to

effectively scale the bioprocess towards manufacturing. Candidates must be highly skilled in pilotscale

bioreactor operation, process scale-up strategies and design of experiments, statistical

analysis, and communication of results. This position will require significant subject matter

expertise and hands-on laboratory work and the ability to lead team members and coordinate with

external suppliers. This position reports directly to the Director, Bioprocess Development.

Essential Responsibilities:

• Lead execution of development and optimization of pilot-scale cell culture.
• Design and implement cell culture scale-up strategies, spanning from pilot-scale working when required, with external service providers (such as CROs or CDMOs), to achieve critical company goals and technological benchmarks. This would include leading small and effective teams on critical process development and technology transfer projects with internal and external teams and when required, perform on-site visits with external collaborators.
• Work cross-functionally with R&D, Engineering, Quality, and Operations to successfully transfer SOPs and related documents that meet target specifications.
• Evaluate new and existing bioprocess technologies, methods, and equipment wit emphasis on scale-up and optimization of cell culture, media preparation and cell recovery.
• Serve as technical lead in discussions with service providers on conceptualization, desig and construction of large-scale bioreactors and other upstream process equipment.
• Develop specifications, procedures, and testing protocols as required for bioprocess development and validation and assist in their execution.
• Facilitate industrial scale milestones that resonate with the quality standards set by the
• BlueNalu leadership and advocate for process enhancements at industrial collaborators aligning with BlueNalu’s functionality goals and overarching objectives.
• Preparation of invention disclosures and other IP documentation as required.
• Collaborate, when required, with suppliers and vendors to effectively source materials and services.
• Some weekend work may be required.

Jobs Supervised (by title):

• Director, Bioprocess Development

Travel:

• 15-20%.

Minimum Qualifications:

• Principal Engineer: Applicants with a PhD and 8+ years of industry experience ar preferred, MS with 10+ years of industry experience in the technology field.
• Senior Engineer: Applicants with a PhD and 5+ years of industry experience are preferred, MS with 8+ years of industry experience in the technology field.
• Proficiency in bioprocess scale-up (fermentation or cell culture or equivalent) and expertise in developing and operating a variety of single-use and stainless-steel bioprocess equipment is required.
• Proven experience working with contract manufacturers and service providers successfully transferring cell culture technologies and demonstrating performance from 10L to 100k scales and leading engineering on-site visits at contract manufacturing and research facilities.
• Proven Experience in working with service providers to specify and design bioproces equipment at pilot-to-manufacturing scale with understanding of the sizing, utility and control requirements required for effective functioning of the bioprocess systems.
• Accurately summarize, interpret, and review experimental data with adequate computer skills
• for data acquisition, data management and visualization of experimental results.
• Experience with independently developing procedural documentation and technology transfer protocols for bioprocesses.
• Prior experience managing individuals or small teams to achieve company’s goals.
• Demonstrated strong background to lead technically driven projects, and ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects.
• Use of DOE and related software to design and analyze experiments.
• High level of initiative to solve problems and ability to multitask and ability to function effectively in a high performance-driven environment.
• Legally authorized to work in the United States.

Nice to Have:

• A history of innovation, creativity, and collaborations with mammalian cell culture and/or food fermentations.
• Hands-on experience and mechanical aptitude for troubleshooting and maintaining bioreactor hardware and SCADA systems including defining and understanding automation requirements to work closely with team members and service providers to design, implement and update automation code in bioprocess equipment.
• Experience working in a GMP environment (and related processes and documentation) is preferred.

Materials and Equipment Directly Used:

• Office machinery including computers, printers, copiers, etc.
• Microsoft Office Suite and Adobe.
• General manufacturing equipment for bioprocessing, food processing and utilities including but not limited to steam systems, water systems, etc.
• General tools used for service and maintenance.

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.

Work Environment:

• 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.
• Meet cleanroom, personnel hygiene and GMP requirements.
• Required flexibility to meet gowning procedures for cleanroom environments.
• Emotional stability and personal maturity are important attributes in this position.
• Must be able to resolve problems, handle conflict and make decisions under pressure.
• 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.
• Able to carry up to 50 lbs or more with the help of support machinery.
• On-site laboratories require exposure to machines, chemicals, and solvents.

Additional Information

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, Inc. 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.

To learn more, visit: www.bluenalu.com

Job Type: Full-time

Pay: $120,000.00 - $180,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Referral program
• Retirement plan
• Vision insurance

Experience level:

• 3 years
• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person
• Manufacturing facility

Education:

• Master's (Required)

Experience:

• cell culture: 4 years (Required)
• specify and design bioprocess equipment: 4 years (Required)
• tech transfer: 4 years (Required)
• operating single-use & stainless-steel bioprocess equipment: 2 years (Required)
• bioprocess scale-up development: 4 years (Required)

Language:

• English (Required)

Work Location: In person