What are the responsibilities and job description for the Process Development Associate I, Downstream position at Abzena?
San Diego, CA
Scientific – Process Development /
Full Time /
On-Site
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
- Executes experiments in protein recovery and purification process development using column chromatography and various other techniques.
- Assists with technical transfer of downstream purification processes from clients and between Process Development and other internal groups like Cell Line Development and MSAT/MFG.
- Assists in scale-up calculations for varying scales of the process — up to cGMP scale.
- Calculates buffer formulations correctly and makes buffers accurately according to protocols.
- Assists in the documentation of observations and collecting data for analysis. Capable of data management. Capable of identifying trends in data and notifying 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 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.
Qualifications
- Minimum BS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry or related fields.
- 1-3 years experience in pharmaceutical or biotechnology field.
- Basic knowledge of recombinant protein expression and protein purification strategies using various chromatographic techniques.
- Basic knowledge in protein chemistry and analytical methods.
- Basic understanding and hands-on experience with AKTA systems and Unicorn software: GE- Pure, Avant, Pilot, and Ready.
- Basic understanding of centrifugation, depth filtration and TFF.
- 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 follow detailed instructions and to maintain accurate records and notes.
- 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.
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.
