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#39;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 Quality Laboratory Manager, you will be responsible for quality testing of BlueNalu#39;s cell-based products#39;. You will demonstrate strong analytical skills, be highly collaborative, consistently proactive, engaged, and persistent in finding solutions and new ideas to achieve BlueNalu#39;s company objectives. This position#39;s initial focus will be on quality testing to support our first cell-based seafood product#39;s scale-up and commercialization. Duties will include coordinating analytical testing as required for regulatory submission, developing specifications and testing protocols, supporting facility qualification, and performing product release testing.
The Quality Laboratory Manager will perform quality tests required to produce cell-based seafood products, maintain analytical data, and follow Good Manufacturing Practices (cGMP) and OSHA regulations. Responsibilities will include the following:
- Performs Quality chemical/biological/cell-based testing for cell-based seafood products raw materials, in-process, release, and stability samples
- Coordinates testing with third party laboratories
- Writes original and revises current SOPs, forms, and test records, including initiating change controls and completing necessary documentation.
- Records test results and maintains raw data and accurate laboratory records
- Actively participates in support of commercialization activities
- Performs validation/qualification of analytical methods, including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation/qualification protocols.
- Initiates Out of Specification (OOS) and deviation investigations as needed to address non-conformances in the lab.
- May supervise junior analysts and technicians.
- Serves as the QC Laboratory Safety Officer
- Maintains laboratory equipment including annual calibration.
- Orders supplies and reagents.
- Performs other duties as assigned.
- Analytical quality testing including ELISA, HPLC, ICP-MS, and/or LC-MS
- Microbiological/cell-based quality testing including sterility, viability, and/or identification testing
- Method validation skills and ability to execute methods/procedures and operate equipment
- Strong analytical skills to evaluate data found through complex testing processes
- Detail orientation and ability to follow specific testing protocols and adhere to rigid safety standards
- Excellent written and verbal communication skills to generate reports and deliver findings
- Ability to prioritize testing workload and multitask efficiently
- Working knowledge of laboratory safety protocols
Qualifications & Experience
- Bachelor#39;s Degree in Food Science, Biochemistry, Chemistry, Microbiology or other related Scientific Discipline.
- A minimum of 3-5 years working in Quality Laboratory in an FDA regulated company
- Experience working with cell culture and/or cultured food products
- Proficient in the use of spreadsheets, databases, and word processing software
- Experience with LIMS systems
- Supervisory experience
- Food safety and food quality testing experience including sensory evaluations a plus
- Dependable and able to work well within a team
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#39;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