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:

This role will focus on late- stage cell line development and validation for use in manufacturing. The Sr. Scientist will work closely with R&D and Process Development teams to generate, validate, and release cell banks. Candidates should have expertise in suspension cell line development including experimental design, problem solving, 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 as well as coordinate with external vendors. Successful candidates will join a high-performance and fast-paced team where everybody’s contribution is equally important. Candidates should be highly motivated, organized, proactive, and able to balance multiple projects.

Essential Responsibilities:

• Lead late stage (suspension) cell line development projects to meet cell line requirements for manufacturing within project timelines
• Develop GMP compliant specifications and testing protocols as required for new cell line development and validation
• Troubleshooting issues that may arise during protocol development
• Must be able to follow protocols, write new protocols, make thorough observations, and keep clear and complete records of work
• Effectively collaborate and work cross-functionally with R&D, Process Development, and Manufacturing to successfully transfer SOPs and cell lines that meet target specifications
• Collaborate with suppliers and vendors to effectively source materials and services
• Lead a small team to achieve project goals and direct activities to meet project milestones
• Train and supervise team members to perform project activities
• Provide regular updates to the project team and management on project timelines and deliverables
• Preparation of invention disclosures and other IP documentation as required
• Some weekend work may be required

Jobs Supervised (by title):

• Associate Director, Cell Line Development

Travel:

• Less than 5%.

Minimum Qualifications:

• PhD in Cell Biology, Biotechnology, Biomedical Engineering, or equivalent
• Applicants with a PhD and 5+ years of industry experience are preferred, or MS with 8+ years of industry experience
• Demonstrated expertise in suspension cell line development (may include microcarrier or spheroid culture systems), cell biology, molecular biology, cell culture, cell metabolism, and cell-based assays
• Hands on experience in cell line development including expansion, cloning and sub-cloning, cell banking, and cell banking validation testing
• Experience working in a GMP environment preferred
• Experience in compiling validation data and drafting reports for regulatory filings
• Track record of successfully leading small teams to achieve project goals
• Demonstrated ability to conceive, plan and execute scientific projects
• Accurately summarize, interpret, and review experimental data with adequate computer skills for data acquisition, data management and visualization of experimental results
• Use of DOE and related software to design and analyze experiments
• Performs work independently and as part of a team to achieve company goals
• High level of initiative to solve problems and ability to multitask
• Excellent verbal and written communication skills and organizational skills
• Sense of humor

Desired skills:

• Familiar with scale up from bench to bioreactor scale cell culture
• Experience with primary muscle and/or fat cell expansion and differentiation
• Experience with high-throughput screening equipment and methods
• Working knowledge of food processing and industry best practices

Materials and Equipment Directly Used:

• Office machinery including computers, printers, copiers, etc.
• Microsoft Office Suite and other computer systems.
• Basic lab equipment such as pH meters, scales, cryo freezers, statistical software (JMP, GraphPad).

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.
• 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.
• Able to carry up to 50 lbs
• On site laboratory, requires 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 align with each of our core values to Be Epicurious, Be Bold, Be A Lighthouse and Be True Blue. 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

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• Monday to Friday

COVID-19 considerations:
BlueNalu takes the safety and wellbeing of our staff and visitors seriously. We are very consciousness about adhering to all state, federal, and OSHA COVID-19 guidelines and have internal policies and protocols in place.

Ability to commute/relocate:

• San Diego, CA 92121: Reliably commute or planning to relocate before starting work (Preferred)

Education:

• Master’s (Preferred)

Experience:

• industry: 5 years (Preferred)
• cell line development and cell banking: 1 year (Required)
• GMP: 1 year (Preferred)
• FDA regulations: 1 year (Preferred)
• bioreactor: 1 year (Preferred)

Language:

• English (Required)

Work Location: One location

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