Abzena · 5 hours ago
Process Development Associate II, Downstream
San Diego, CA
Full-time
Onsite
Mid Level
$70K/yr - $80K/yr
3+ years expAbzena is a dedicated partner in the development and manufacturing of biologics and bioconjugates. The Process Development Associate II will perform process development activities, collaborating across departments to devise scalable and robust processes while ensuring quality and compliance with regulatory standards.
BiopharmaBiotechnologyLife SciencePharmaceutical
Responsibilities
Designs and executes process development experiments to develop a thorough understanding of operating and performance parameters and identifies promising areas for process improvements. Effectively analyses experimental results and designs and executes follow-up experiments that build upon previous results
Provides training to new personnel in specific technical processes, as needed
Performs process development activities for projects and products in collaboration with other individuals and departments
Actively participates in technical transfer of downstream purification processes from clients and between Process Development and other internal groups like Cell Line Development and MSAT/MFG
Actively participates in performing scale-up calculations across varying scales of the process — up to cGMP scale
Develops buffer formulations and makes buffers accurately according to protocols
Actively participates in the documentation of observations and collection of data for analysis. Participates in data management and the identification of trends in data and notification of scientists of possible impacts to processes and products
Conducts activities in support of production schedules and objectives as directed by senior staff
Troubleshoots challenging technical, experimental, and instrumental issues
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 AKTA systems and biosafety cabinets
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 purification under cGMP standards for production of 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
Required
BS or MS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry or related fields with 3+ (BS) or 2+ (MS) years' experience in the pharmaceutical or biotechnology fields
Strong knowledge of recombinant protein expression and protein purification strategies using a variety of chromatographic techniques
Strong knowledge in protein chemistry and analytical methods
Good understanding and extensive hands-on experience with AKTA systems and Unicorn software: Cytiva - Pure, Avant, Pilot, and Ready
Good understanding and extensive hands-on experience with centrifugation, depth filtration and TFF/UFDF
Knowledge of buffer formulation and preparation
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities
Skilled with Microsoft Office suite
Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required
Skilled in problem solving and troubleshooting
Ability to safely operate production equipment in accordance with established practices
Preferred
Practical experience with cGMP manufacturing operations and fluency of regulatory regulations is desired
Company
Abzena
Abzena is a biotechnology company that offers biologic and ADC products from concept to clinic.
501-1000 employees
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 CompanyTotal Funding
$139.44MKey Investors
Biospring PartnersProVen VCT
2022-03-31Private Equity· $65M
2020-07-28Private Equity· $10M
2018-08-16Acquired
Leadership Team
Geoffrey Glass
Chief Executive Officer
Daniel Giroux
Vice President, Development
Recent News
Genetic Engineering News
2025-11-08
2025-10-24
Company data provided by crunchbase