About the job
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. Our products will contain no mercury, microplastics or other contaminants.
Job Summary:
The core responsibility of the Senior Scientist, Analytical Development is to develop, optimize, and validate analytical techniques and assays to support R&D, quality control and regulatory. This role will focus on understanding the analytical needs, available technologies and resources, and documentation required to evaluate and introduce appropriate analytical techniques. Candidates should have expertise in a range of analytical tools, assay development methodology, statistical analysis, assay validation and documentation, and project management. 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 partners. This position reports directly to the Chief Technology Officer.
Essential Responsibilities:
- Lead analytical method development from concept to validation and transfer to support needs across the entire process
- Effectively conceptualize, plan, and execute projects to contribute to analytical development goals
- Develop specifications, procedures, and testing protocols as required for new analytical assays
- Work cross-functionally with R&D, Quality, Regulatory, and Manufacturing to successfully transfer SOPs required for process and product testing
- Lead a small team to achieve project goals and direct activities to meet project milestones
- Evaluation and implementation of novel processes and analytical tools to meet assay needs
- Train and supervise team members to perform project activities
- Draft documentation and manage technology transfer of new analytical techniques and/or assays
- Lead method qualification/validation in a cGMP setting and method transfer to internal and/or external QC laboratories
- Collaborate with external testing labs to support development or testing as appropriate
- Support troubleshooting of existing assays and/or updates to SOPs
- 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):
- Chief Technology Officer
Travel:
- As required from time to time
Minimum Qualifications:
- MS or PhD in Biochemistry, Molecular Biology, Chemistry, Cell Biology, or equivalent
- Applicants with a PhD and 5+ years of industry experience are preferred, MS with 8+ years of industry experience, in the technology field
- Expert knowledge in analytical methods, development of new assays, and related scientific principles and concepts
- Demonstrated proficiency in molecular biology, cell-based assays, and analytical chemistry
- Understanding and hands-on experience with various analytical methods including but not limited to, PCR, NGS, ELISA, HPLC, LC/MS, Capillary Electrophoresis, Cytometry/FACS, Luminescence/Fluorescence plate-based assays, Immunofluorescence microscopy, and high content imaging.
- Ability to perform qualification and manage maintenance of laboratory equipment and instrumentation
- Excellent project management, communication, and interpersonal skills
- Demonstrated strong background to lead technically driven projects, and ability to effectively work in cross functional teams, meet deadlines, and prioritize multiple projects
- Track record of successfully leading small teams to achieve project goals
- Accurately summarize, interpret, and review experimental data with adequate computer skills for data acquisition, data management and visualization of experimental results
- Experience with analytical and statistical software to design and analyze experiments
- High level of initiative to solve problems and ability to multitask
- Validation experience using quality and regulatory requirements such as FDA, GLP/cGMP compliance
- Exceptional interpersonal skills and organizational skills, with impeccable attention to detail
- Legally authorized to work in the United States.
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