Responsibilities
Designs and executes process development experiments to develop a thorough understanding of operating and performance parameters to define downstream purification processes.
Effectively analyses experimental results and designs and executes follow-up experiments that build upon previous results.
Leads process development activities for projects and products in collaboration with other individuals and departments.
Leads the technical transfer of downstream purification processes from clients and between Process Development and other internal groups like MSAT and MFG.
Leads performing scale-up calculations across varying scales of the process — up to cGMP scale.
Develops buffer formulations and makes buffers accurately according to protocols.
Documents observations and collects data for analysis.
Analyzes and manages data to identify trends, assess potential process and product impacts, and identify opportunities for improvement.
Conducts activities in support of production schedules and objectives as directed by senior staff.
Authors study protocols, experimental designs, technical transfer reports and development reports with guidance
Interfaces with clients, as needed, to follow the development of their program from start to finish.
Oversees junior personnel and works interdepartmentally to ensure PD lab requirements are met.
Maintains lab organization and cleanliness by regularly stocking supplies and managing supply inventory.
Assembles and autoclaves tubing assemblies.
Maintains cleanliness of specific equipment such as AKTA systems and biosafety cabinets.
Assists scientists in data review and interpretation.
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 clinical trial material.
Operates to the highest ethical and moral standards.
Complies with Abzena’s policies and procedures.
Adheres to quality standards set by regulations and Abzena policies, procedures and mission.
Communicates effectively with supervisors, colleagues, and staff.
Participates effectively as a team player in all aspects of Abzena’s business.
Travels as needed between sites, and to attend professional conferences and train on new technologies.
As needed, assists with protein production under cGMP standards for production of clinical trial materials.
Performs other duties as assigned.
Qualifications
BS or MS degree in biological sciences, chemistry, chemical engineering, biotechnology, biochemistry or related fields with 6+ (BS) or 4+ (MS) years’ experience in the pharmaceutical or biotechnology fields.
- Advanced knowledge of recombinant protein purification strategies using a variety of chromatographic techniques.
Advanced knowledge in protein chemistry, quantitative and qualitative analytical methods and interpretation of analytical data.
Strong understanding and extensive hands-on experience with AKTA systems and Unicorn software: GE- Pure, Avant, Pilot, and Ready.
Strong understanding and extensive hands-on experience with centrifugation, depth filtration, TFF and principles of these operations.
Knowledge of buffer formulation and preparation.
Ability to follow instructions with minimal to no supervision and to maintain accurate records and notes to assist in writing detailed development reports.
Practical experience with cGMP manufacturing operations and fluency of regulatory regulations is desired.
Ability to organize workload, oversee workload of associates and lab technicians, and manage relevant resource requirements.
Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required.
Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.
Experience applying out-of-the box thinking to creatively develop solutions to day-to-day experimental challenges.
Skilled in leadership duties including time management and planning.
Skilled in data management.
Skilled with Microsoft Office suite.
Skills in problem solving and troubleshooting.
Ability to safely operate production equipment in accordance with established practices.
Physical Requirements
- Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
- Frequently lift and or move objects up to 30 pounds.
- Stand/walk during entire length of shift.
- Use arms, hands and fingers to handle, feel or reach.
- Ability to climb, balance, stoop, kneel, crouch, or crawl.
- Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.
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.