Overview
With extensive experience in developing biologics and bioconjugates, we offer a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing.
Forward-thinking and committed, we find the best solution and use the right technologies to design, develop and manufacture your products to ensure we get vital medicines to patients quickly and safely.
We are dedicated to quality excellence. We are driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services.
We are Abzena. More than a CDMO, we are a responsible and dedicated partner that takes care of your products from concept to patient.
The Associate I performs process development activities in collaboration with other individuals and departments to devise scalable and robust processes on accelerated timelines.
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.
- As needed, assists with protein production under cGMP standards for clinical trial material.
- 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.
- Skilled 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.
