Senior Engineer, MSAT (Powder)

Nucleus Biologics • San Diego, CA

3d

About The Position

This role will be primarily responsible for leading process development, scale-up, optimization, and technical transfer of powdered cell culture media manufacturing processes. This includes implementing product/process development to support robust customer portfolios. This position will report to Associate Director, MSAT.

Requirements

• Requires a BS or MS degree in Chemistry, Biochemistry, Organic Chemistry, Chemical Engineering or related field
• BS degree: 5+ years of related experience
• MS degree: 4+ years of related experience
• Strong fundamental knowledge in chemistry
• Knowledge of GMP documentation and regulatory expectations
• Experience with scale-up and technology transfer in a GMP environment
• Strong troubleshooting and root cause analysis skills
• Ability to self-manage multiple projects and priorities simultaneously
• Thrive in a fast paced, start-up environment and must be able to meet critical deadlines
• Detail-oriented with excellent written and verbal communication skills
• Technical leadership with strengths in problem-solving and analytical thinking
• Intermediate to advanced skills in Word, Excel and PowerPoint
• Continuous improvement mindset

Nice To Haves

• Previous work experience with cell culture media hydration and buffer formulation
• Strong knowledge of powder processing operations (e.g., blending, particle size control, material handling)
• Six Sigma or Lean Manufacturing certification is a plus

Responsibilities

• Lead development and optimization of powdered cell culture media formulations and manufacturing processes (blending, milling, and packaging)
• Design and execute scale-up studies from pilot to commercial manufacturing
• Author, review, and execute Standard Operating Procedures (SOPs), batch records, process development studies, and technical documentation based on experimental results
• Evaluate dry powder milling and blending processes for mixing uniformity and particle size distribution (PSD) and implement improvements to enhance yield, homogeneity, and efficiency
• Utilize and support operation of processing equipment including mills, blenders, and sieving/screening systems
• Ensure proper dust control, containment, and safe material handling practices
• Support validation activities, including process validation, equipment qualification, and cleaning validation
• Collaborate cross-functionally with R&D, Quality, Regulatory, and Manufacturing teams
• Provide technical support to Project Management during customer onboarding and project execution
• Design, execute, and analyze experiments for process improvements and troubleshooting of cell culture media and buffer formulations
• Support rapid turnaround (TAT) for feasibility assessments and onboarding of new projects; generate data to inform strategic upstream decisions
• Train manufacturing personnel on new processes
• Facilitate clear communication with cross-functional teams and key stakeholders
• Contribute to the development and implementation of automated systems and process improvements
• Contribute to a collaborative, high-performing team environment

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees