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 will 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.
BlueNalu will be moving from its current R&D and Administrative offices in San Diego to a new 40,000 s.f. facility over the next 9-12 months, which will incorporate a new headquarters operation, R&D and QA offices, and a GMP-inspected operation for limited commercial production of BlueNalu’s various cell-based seafood products to our initial test markets.
The Vice President of Operations is a new position at BlueNalu, and will lead the commissioning and the ongoing operation of BlueNalu’s pilot manufacturing facility for cell-based seafood, which will be the first such facility of its kind anywhere in the world. The role reports directly to the President & CEO and will part of the company’s executive leadership.
This new facility is approximately 40,000 sq. ft., and will include a hygienically-designed, Good Manufacturing Practices (GMP) food production plant that will be designed for limited commercial production of BlueNalu’s various cell-based seafood products in our initial test markets. This pilot plant maintains all the critical systems and operations similar to therapeutic biotech plant, and will continually be introducing products derived from new species, and will also continually be introducing new product applications, and presentations.
This individual will oversee the management of manufacturing operations (media prep, upstream cell culture, harvesting, downstream product formation, and processing) and related support teams (equipment stewardship, maintenance, utility management, batch record writing, capital expansion and improvement projects) involved in producing seafood products in a cell culture manufacturing facility. In addition, he/she will lead manufacturing readiness activities enabling the successful start-up of the facility. He/she will have responsibility for adherence to schedule, quality and cost objectives, ensuring effective execution of site start-up and production commitments while maintaining the highest ethical and FDA compliance standards.
- Provide input to the manufacturing design and installation of a new 40,000 s.f. commercial manufacturing facility for cell-based seafood, working in collaboration with BlueNalu’s contracting organizations that have already been selected
- Provide expert guidance on capital expenditures, and take responsibility for equipment installation, commissioning, regulatory qualification and process verification through preliminary engineering runs.
- Work in strong collaboration with BlueNalu’s Director of Quality Assurance & Regulatory Affairs and serve as primary receiver of the tech transfer process by designing master batch records and creating standard operating procedures and other GMP-required manufacturing documentation.
- Develop and manage systems for supply chain, inventory management, and best practices in procurement.
- Formulate and implement the strategic and tactical planning to enable a successful start-up of the facility that achieves successful commercial operations.
- Work with HR to manage the execution of the manufacturing department’s initial staffing plan to include initiation of requisitions, recruiting, and hiring.
- Oversee the development and implementation of an effective onboarding and training for new hires.
- Participate in the cross-functional facility operational readiness team effort to meet project milestones and ensure all manufacturing aspects of the start-up are properly planned and executed.
- Directly manage manufacturing staff to ensure the timely delivery of product within cGMP compliant manufacturing operations.
- Develop an engaged, high-performing team, and lead a culture of learning, respect, and employee growth.
- Participate in establishing department long and short-term goals. Direct and monitor department managers in accomplishing goals.
- Lead staff hiring and guide the cultural and professional growth of team members by providing personal guidance and relevant proficiency, safety, and quality training.
- Provide clear direction and balanced performance feedback.
- Actively participate in corporate culture initiatives, and lead where appropriate
- Serve as a manufacturing subject matter expert (SME) to inform leadership decisions, facilitate planning, oversee improvement projects, prepare for and pass regulatory inspections, and ensure the smooth functioning of day-to-day manufacturing operations.
- Create a culture of safety leadership. Oversee the implementation of safety programs to ensure a safe working environment and compliance with all applicable state and federal requirements.
- Champion a culture of continuous improvement that leverages Lean manufacturing principles to identify and implement efficiency and quality enhancement opportunities.
- Recruit and train staff as equipment operators for the various steps of the manufacturing process.
- Work with Quality Assurance personnel to ensure regulatory compliance and aseptic operation where required as well as lead the manufacturing team in executing the facility qualification
- Supervise routine manufacturing by leading and managing operators, warehouse and shipping personnel and coordinate equipment and facility maintenance.
- Lead technical investigations of process deviations and assess their potential impact on product quality as well as leading discussions and influencing stakeholder acceptance of critical process and quality-based decisions.
- Ensure that appropriate process data are recorded and analyzed to monitor run-to-run consistency for Upstream operations across internal and CMO production campaigns
- Present and document Cell Culture Manufacturing Technology Transfer status/updates and monitoring/trending of historical process performance, and tech transfer/campaign summary reports
- Full knowledge of current Good Manufacturing Practices (cGMPs)
- Extensive experience with animal cell bioreactor operation, controls, maintenance, and troubleshooting, and aseptic operations including implementing precautionary measures and microbial testing and performing root cause analysis in the event of a contamination.
- Significant experience with upstream bioprocessing equipment and operations from thaw through harvest. In-depth understanding of cell culture scale-up, engineering principles, and associated equipment – i.e., growth rates, specific consumption/production rates, bioreactor design and geometry, power calculations, gas flow/velocities, shear stress
- In-depth understanding of cGMP requirements for commercial manufacturing, experience with assisting in the generation of relevant data to support regulatory filings, data capture and management, process monitoring and trending, including control charting and statistical process control, and supporting regulatory and site inspections.
- Knowledge and operation of related cell culture and primary recovery equipment and unit operations
- Experience in project engineering and management within an FDA inspected facility, and the equipment and sanitation requirements associated with best practices in hygienic food manufacturing
- Experience with extrusion, food processing, and food packaging equipment within an FDA or USDA inspected operation.
- Understanding of aseptic techniques and control of microbial contamination
- Ability to partner cross-functionally on proprietary process technologies, while also developing and leveraging successful external contacts and relationships.
- Strong scientific and technical writing and presentations.
- Detail oriented with excellent verbal and written communication skills.
- Innovative and creative thinking and willing to challenge established methods and beliefs
- Self-starter with a strong bias for action and ability for problem-solving and troubleshooting
- Knowledge of control and automation software and hardware systems desired
- Familiarity with advanced project management tools desired
Qualifications & Experience:
- The position requires a minimum of a BS in Chemical Engineering, Biomedical Engineering, Chemistry, Biochemistry, Food Science or a related field, and a MS degree is preferred
- Previous 10+ years facility management and/or pilot plant production experiences within an FDA inspected operation, working in manufacturing in a regulated environment for food, pharma, or biologics products
- Familiarity with the CFR related to food manufacturing, EU Annex 2, the FDA initiatives on data integrity, and 21 CFR part 11 on electronic data and signatures
- Demonstrated strong background to lead technically driven projects, and ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
- Exceptional interpersonal skills and organizational skills, with impeccable attention to detail, and strong professional written and verbal communication skills
- Proficient computer skills and preferably familiar with Rockwell Automation systems and HVAC control systems.
- Experience in technology transfer and new product and process development
- Preferred to have Certification as a Preventive Controls Qualified Individual (PCQI), and/or as a Safe Quality Foods (SQF) Practitioner, and/or in HACCP, and/or in Better Process Control School, or other experience with food safety culture planning and implementation
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