Process Engineer II

Our Client is seeking a highly motivated and detail-oriented individual with process development experience to work on innovative T cell therapies for cancer treatment The Process Engineer I or II will be responsible for designing and executing experiments in the lab, help process development, process characterization, technology transfer activities, support or improve existing technologies, implement innovative solutions in commercial, and clinical manufacturing to advance the client's product portfolio Additional responsibilities include analyzing and presenting experimental results, drafting / reviewing protocols, production procedures, and technical reports including documentation for regulatory filings Process Engineer I or II will work on Autologous Process Design and Development within the Life Cycle Management Team


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.

Requirement:

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.
Well-developed computer skills.
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.

Education Level
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.

Benefits:

Benefits
Full-time employees (working an average of 30 hours or more) are eligible to select from different benefits packages Packages may include medical, dental, and vision benefits, a 401(k) retirement savings plan with employer match (available after 1 year of employment), commuter benefits, employee discount and referral programs, and life and supplemental income insurance Paid sick leave is provided in accordance with applicable state and local laws.

Compensation
Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education, and experience, as well as the benefits package you select.

Work Authorization
ATR International, Inc cannot sponsor work visas (H-1B, F-1 STEM OPT with I-983, or similar) Candidates must have valid U.S work authorization.

ATR International, Inc is an equal opportunity employer We celebrate diversity and are committed to creating an inclusive environment for all employees.