Process Development Associate I, Upstream

Responsibilities

• Assists in cell culture production using aseptic techniques and following protocols and procedures.
• This includes, but is not limited to:
• Thaw, maintenance, and expansion of cell culture in shake flasks
• Freeze of Development Cell Banks
• Inoculation of bioreactors in a rocker and STR at scales of 2 L – 200 L
• Maintenance of cell culture by determining cell count, metabolite concentrations, pH, and gassing
• Assists with technical transfer of upstream manufacturing processes from clients and between Process Development and other internal groups like Cell Line Development and MSAT/MFG.
• Assists in doing scale-up calculations for varying scales of the process — up to cGMP scale.
• Accurately makes components, media, buffers and other solutions.
• Assists in the documentation of observations and collecting data for analysis.
• Participates in data management and the identification of trends in data and the notification of scientists of possible impacts.
• Conducts activities in support of production schedules and objectives as directed by senior staff.
• Maintains detailed records to comply with regulatory requirements and assists with in-process testing.
• Maintains lab organization and cleanliness by regularly stocking supplies, scheduled cleanings, and managing supply inventory.
• Assembles and autoclaves tubing assemblies.
• Maintains cleanliness of specific equipment such as incubators, biosafety cabinet, and water baths.
• Maintains up-to-date knowledge of quantitative and qualitative analytical methods.
• Represents Process Development and its activities as needed during project team meetings, training, and evaluation of new technologies.
• Operates to the highest ethical and moral standards.
• Complies with Abzena's policies and procedures.
• Communicates effectively with clients, supervisors, colleagues and staff.
• Participates effectively as a team player in all aspects of Abzena's business.
• Adheres to quality standards set by regulations and Abzena policies, procedures, and mission.
• Performs other duties as assigned.

Qualifications

• Minimum BS degree in biological sciences, biotechnology, biochemistry or related fields.
• 1-3 years experience in pharmaceutical or biotechnology field preferred.
• Basic knowledge of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization.
• Basic knowledge of cell culture process steps including cell banking, thaw and expansion, production (batch-fed and perfusion), and harvest.
• Skilled in operating ambr250 and STRs (2 L, 50 L, and 200 L); Sartorius STR experience preferred.
• Knowledge and skill in using equipment for determining cell counts and cell metabolism.
• Knowledge in single-use technologies.
• Basic knowledge of quantitative and qualitative analytical methods and interpretation of analytical data.
• Skills in data management.
• Skills in problem-solving and troubleshooting.
• Ability to follow instructions and to maintain accurate records and notes to write detailed development reports.
• Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired.
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
• Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required.
• Skilled with Microsoft Office suite.
• Ability to safely operate production equipment in accordance with established practices.