Senior Process Development Engineer, Pilot Operations
TITLE: Senior Process Development Engineer, Pilot Operations REPORTS TO: Director, Bioprocess Development
LOCATION: San Diego, CA Document Date: 08/10/2023
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 develop and optimize cell culture and recovery at pilot scale. 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 pilot-scale 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 as well as the ability to lead team members and coordinate with external suppliers. This position reports directly to the Director, Bioprocess Development.
Essential Responsibilities:
- Lead execution and optimization of pilot-scale cell culture
- Support development and optimization of media preparation and cell recovery systems in the pilot plant.
- Lead technology transfer of optimal processes to manufacturing and assist in training of technical operators.
- Evaluate new and existing bioprocess technologies, methods, and equipment with emphasis on scale-up and optimization of cell culture, media preparation and cell recovery.
- Assist in maintenance of the process equipment in the pilot plant and critical mechanical and automation updates to the equipment to facilitate bioprocess scale-up and operations.
- Assisting in execution and independently drafting relevant technical documentation associated with installation, commissioning, and qualification of pilot-scale bioprocess equipment.
- Review and maintain functional specifications for the pilot-scale bioprocess equipment and serve as in-house SME for pilot-scale bioprocessing systems.
- Develop specifications, procedures, and testing protocols as required for bioprocess development and validation.
- Work cross-functionally with R&D, Engineering, Quality, and Manufacturing to successfully transfer SOPs and related documents that meet target specifications.
- Collaborate with suppliers and vendors to effectively source materials and services.
- 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):
Director, Bioprocess Development
Travel:
Less than 5%.
Minimum Qualifications:
- 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 demonstrated expertise in developing as well as operating a variety of single-use and stainless-steel bioprocess equipment is required.
- 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.
- 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.
- Experience working in a GMP environment (and related processes and documentation) is preferred.
- Experience in specifying and designing bioprocess equipment at pilot-to-manufacturing scale with understanding of the sizing, utility and control requirements required for effective functioning of the bioprocess systems, is preferred.
- 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.
- Some proven supervisory experience is required.
- 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.
- Exceptional interpersonal skills and organizational skills, with impeccable attention to detail.
- Legally authorized to work in the United States.
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:
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- 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.
- 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.
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