Abzena
Process Development Associate I, Upstream
Abzena, San Diego, California, United States, 92189
Process Development Associate I, Upstream
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Process Development Associate I, Upstream
role at
Abzena
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
$60,000 - $70,000 a year
FLSA:
Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
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Process Development Associate I, Upstream
role at
Abzena
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
$60,000 - $70,000 a year
FLSA:
Non-Exempt
Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.
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