Aptask Global Workforce (AGW) is seeking a Process Engineer II for an Onsite position with a Biotechnology Company located in Santa Monica, CA. This is a 12+ month contract opportunity. This role will join the Process Design team to develop innovative manufacturing processes for T cell therapies. The successful candidate will provide hands-on lab support for studies supporting new INDs, technology transfers, process validations, and GMP manufacturing. You will work with a highly motivated team to design and scale cell therapy processes to advance our client's product portfolio.

Responsibilities:

Hands-on lab work and collaboration on process design studies to support process development, optimization, characterization, and essential process improvements Perform process training for GMP clinical production Participate in a cross-functional development team to advance CMC activities Perform process analysis and trend process performance Develop manufacturing processes for cell therapy products Design and execute process development studies to develop a thorough understanding of operating and performance parameters Perform statistical analysis, including design of experiments (DOEs) as appropriate Write and review technical documentation from writing technical SOPs, study plans, draft manufacturing batch records, technical reports, and summary reports Create slides and supporting data to communicate results to senior leadership Other collaboration and cross-functional activities as assigned

Requirements:

MS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 0 years of pharmaceutical manufacturing, technology transfer & process development experience required BS Degree in Biochemical Engineering, Chemical Engineering, or related discipline with 2 years of pharmaceutical manufacturing, technology transfer & process development experience required Demonstrated cell culture and aseptic technique experience is required, including basic cell culture, preparation of media, cell counting, managing reagents and cryopreservation Ability to think critically, and demonstrated troubleshooting and problem-solving skills Excellent interpersonal, verbal, and written communication skills are required 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 cross-functional teams, i.e., Research, Translational medicine, Process development, Manufacturing, MSAT in a fast pace, the dynamic team setting Desired skills: Basic knowledge of Immunology and T-cell biology Practical knowledge of cGMP manufacturing and regulatory regulations and requirements for pharmaceuticals and devices Practical demonstration of hands-on process development, including using the statistical design of experiments Experience with bioreactors Understands and employs principles and concepts of Lean Six Sigma or design of experiments to improve process capability is a plus Experience in statistical analysis using JMP or Minitab Knowledge of data management tools and statistical process controls Pay range: up to $51.25 per hour Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position. If you have the described qualifications and are interested in this exciting opportunity, apply today! Aptask Global Workforce (AGW) ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery. Benefits of working with ApTask Global Workforce include: Medical Dental Vision Sick Pay (for applicable states/municipalities) Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/. ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran. #INDAGW