Apeel Sciences is seeking a highly motivated, creative, and research-oriented formulation process scale-up expert to join our team. As a key member of our R&D department, you will be responsible for optimizing and scaling up formulations from lab-scale to commercial production. Your expertise will ensure the successful transition of products from development phases to full-scale manufacturing, meeting quality, cost, and timeline objectives.
This position will report to the Senior Director, Apeel Labs and will be based out of our headquarters in Goleta, California. We’re looking for someone to join our team immediately.
What You’ll Do
Develop and implement strategies for scaling up formulations from lab-scale to pilot and commercial-scale production.
Conduct feasibility studies and risk assessments to identify potential challenges and mitigation strategies in scaling up processes.
Collaborate closely with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs to ensure alignment and successful execution of scale-up activities.
Work closely with external manufacturers, CMOs, or CDMOs for the transfer of mixing operations and specifications.
Design and execute experiments to optimize formulation processes for stability, efficacy, and manufacturability.
Define and implement process parameters, specifications, and control strategies to maintain product quality and consistency during scale-up.
Troubleshoot and resolve technical issues related to scale-up, ensuring adherence to regulatory requirements and industry standards.
Provide technical expertise and support for process validation activities, including protocol development, execution, and reporting.
Stay abreast of industry trends, emerging technologies, and best practices in formulation development and scale-up, including knowledge, design, and implementation of scalable in-process controls (IPCs) and product release testing.
What You Bring
Ideal candidates for this position will hold an advanced degree (PhD preferred) in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related STEM field.
Hands-on experience (2+ years) in formulation process development, including mixing scale-up and optimization within the pharmaceutical, biotechnology, or related industries.
In-depth knowledge of formulation techniques, process optimization, scale-up methodologies, and IPC development for multi-phase systems, including emulsions, dispersions, and liquid concentrates.
Analytical skills with experience in statistical analysis and DOE (Design of Experiments), and demonstrated application to process optimization and troubleshooting.
Knowledge of solution characterization techniques including but not limited to turbidity, viscosity, rheology, and particle sizing.
Excellent project management skills with the ability to prioritize tasks and manage timelines effectively.
Ability to communicate complex technical information clearly and effectively across different functions and levels of the organization.
Problem-solving mindset with a track record of successfully overcoming challenges in scale-up processes.
Experience and comfort with equipment design and fabrication
Candidates with experience in modeling of large-scale mixing process are preferred
Ability to perform indoor and outdoor work in cold or hot environments, and the ability to lift and move boxes of fruit (up to 40 lbs).
Up to 20% travel (domestic and international) may be required
Our total rewards packages may include comprehensive health plans, 401k matching, equity, flexible PTO, sick leave, paid parental leave, and more! Compensation for this role is expected to be between $123,000 and $145,000. Actual base pay may be higher or lower depending on geographic locations, skills, experience, and other factors permitted by law.
