Senior Engineer, MSAT (Powder) at Nucleus Biologics

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

17 Jun, 26

Salary

115000.0

Posted On

19 Mar, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Scale-Up, Optimization, Technical Transfer, Powder Processing, Cell Culture Media, Blending, Milling, Packaging, SOP Authoring, Root Cause Analysis, Troubleshooting, GMP Documentation, Cross-functional Collaboration, Process Validation, Data Analysis

Industry

Biotechnology

Description

About the role 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. What you'll do · 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 Qualifications EDUCATION: · 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 REQUIRED 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 PREFFERED SKILLS: · 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 PHYSICAL REQUIREMENTS: Ability to hear and speak to employees and external associates on the phone and in person. Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision) Ability to walk and/or drive between buildings on campus, up to .3 miles for San Diego based positions [for manufacturing positions only] Ability to lift at 25 lbs. to a height of 3-4 feet on a regular basis. TRAVEL REQUIREMENTS: May require travel to and from Nucleus Biologics offices or customer/vendor locations based on position. NOTE: The above statements are intended to describe the general nature and level of work being performed by incumbents. They are not intended to be an exhaustive list of all responsibilities, duties and skills required by all incumbents. Incumbents may perform other duties as assigned. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Management retains the right to add to or change the duties of the position at any time.

Responsibilities

This role leads the development, scale-up, optimization, and technical transfer of powdered cell culture media manufacturing processes, including blending, milling, and packaging operations. Responsibilities also involve authoring technical documentation, executing scale-up studies, and ensuring compliance with safety and quality standards.