Pharmaceutical Process Engineer

ACL Digital; Santa Monica (CA); On-site; USD 110,000 - 140,000; Full time

Job summary

ACL Digital is seeking a Manufacturing/Process Engineer II to lead cell therapy process development on automated platforms and contribute to technology transfer and GMP manufacturing operations. The role requires hands-on lab work, study design, and data-driven decision making.

Successful candidates will have advanced degrees in engineering with experience in biopharma manufacturing, cGMP regulations, and strong communication skills for cross-functional teams.

Qualifications

• MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with pharmaceutical/biotechnology manufacturing & process development with 2+ years of experience or
• BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotechnology manufacturing & process development with 4+ years of experience or
• AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical/biotechnology manufacturing & process development with 5+ years of experience or
• High School diploma with 6+ years of pharmaceutical/biotechnology manufacturing & process development experience.

Responsibilities

• Conduct cell therapy process development experiments using automated platforms.
• Design and execute studies to evaluate, develop and implement new technologies and materials.
• Perform hands-on lab activities in a cell culture lab, including study design and data analysis.
• Perform process or equipment analysis and trend performance.

Skills

Cell culture techniques

Design of Experiments

Statistical analysis

Process development

Cross-functional collaboration

Education

MS in Biochemical/ Chemical/Biomedical Eng

BS in Biochemical/Chemical/Biomedical Eng

AS in Biochemical/Chemical/Biomedical Eng

High School diploma with related experience

Tools

JMP

Minitab

Flow cytometry

Job description

Title: Manufacturing/Process Engineer II

Schedule: M-F 9:00-17:00, occasional weekends depending on business needs

Contract: Potential for conversion depending on needs of business at the end of 12 month contract

Key responsibilities:

• Conduct cell therapy process development experiments using automated platforms.
• Design and execute laboratory studies that support the evaluation, development and implementation of new technologies and materials.
• Perform hands-on lab-based activities in a cell culture lab, including conception of study designs and analysis of data
• Perform process or equipment analysis and trend process or equipment performance.
• Develop manufacturing equipment for cell therapy products including hardware, software, and single-use disposable design elements and user-requirements.
• Participate in the evaluation of new technologies and materials for introduction into GMP manufacturing
• Provide process training to GMP manufacturing personnel.
• Support technology transfer and GMP manufacturing operations as needed.
• Perform statistical analysis using software such as JMP, Minitab and perform design of experiments (DOEs) as appropriate.
• Write and review technical documentation, technical SOPs, draft manufacturing batch records, technical reports and summary reports.
• Create and present slides with supporting data to communicate results to stakeholders, cross-functional project teams, senior leadership or external collaborators.
• Perform other duties as assigned.

Qualifications and Education:

• MS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology, or related discipline with pharmaceutical / biotechnology manufacturing & process development with 2+ year of experience or
• BS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 4+ years of experience or
• AS Degree in Biochemical Engineering, Chemical Engineering, Biomedical Engineering, Biotechnology or related discipline with pharmaceutical / biotechnology manufacturing & process development with 5+ years of experience or
• High School diploma with 6+ years of pharmaceutical / biotechnology manufacturing & process development experience.

Experience:

• Working experience on automated cell therapy platforms
• Established cell culture lab techniques and aseptic processing in an ISO 5 environment such as cell passaging, sampling, fluid handling, media formulation, managing reagents, and cryopreservation.
• Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices.
• Practical demonstration of hands-on process development including use of bioreactors and use of statistical design of experiments is required.
• Mastery of scientific and engineering principles related to bioprocessing including scale-up / scale-out approaches, hydrodynamics, mass transfer, and bioreactor design and monitoring fundamentals.
• Fundamental understanding of cell biology principles, sub-population types, differentiation, phenotype markers and metabolic pathways.
• Knowledge of material science and material compatibility for cell culture applications
• Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, aseptic processing, cell therapy products and process development.
• Ability to think critically, troubleshoot, and problem solve in a timely manner.
• Excellent interpersonal, verbal and written communication skills are required.
• Ability to function efficiently and independently in a changing environment.
• Self-motivated, strong sense of responsibility, and willing to accept temporary responsibilities outside of initial job description.
• High energy level and a positive outlook coupled with the requisite "can do" attitude and a willingness to do what it takes to achieve personal and organizational goals and overcome obstacles.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to work and collaborate in a fast pace dynamic cross-functional team setting across research, development, and manufacturing departments.
• Flow cytometry knowledge is a plus
• mRNA handling and process knowledge is a plus.