Process Development Associate II, Downstream

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 II performs process development activities in collaboration with other individuals and departments to devise scalable and robust processes on accelerated timelines.

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.
  
  

Qualifications

• 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.
• Practical experience with 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.
• 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.
  
  

$70,000 - $80,000 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.