Process Development Associate I, Upstream jobs in United States
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Abzena · 1 hour ago

Process Development Associate I, Upstream

Abzena is a company dedicated to developing biologics and bioconjugates, ensuring quality excellence in getting vital medicines to patients. The Process Development Associate I will perform process development activities, collaborating with various departments to create scalable and robust processes efficiently.

BiopharmaBiotechnologyLife SciencePharmaceutical
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H1B Sponsor Likelynote

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

Qualification

Mammalian cell culturesCGMP manufacturingData managementProtein productionQuantitative analysisSingle-use technologiesMicrosoft OfficeProblem-solvingTeamwork

Required

Minimum BS degree in biological sciences, biotechnology, biochemistry or related fields
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)
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
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

Preferred

1-3 years experience in pharmaceutical or biotechnology field preferred
Sartorius STR experience preferred
Practical experience of cGMP manufacturing operations and fluency of regulatory regulations is desired

Company

Abzena

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Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.

H1B Sponsorship

Abzena has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2020 (2)

Funding

Current Stage
Public Company
Total Funding
$139.44M
Key Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired

Leadership Team

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Geoffrey Glass
Chief Executive Officer
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Daniel Giroux
Vice President, Development
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Company data provided by crunchbase