Process Development Associate II, Upstream

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.

• Actively participates 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
• 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 upstream manufacturing 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.
• 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.
• Provides technical assistance to scientists.
• Conducts activities in support of production schedules and objectives as directed by senior staff.
• Maintains records to comply with regulatory requirements and assists with in-process testing.
• 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 incubators, biosafety cabinets, 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 production of clinical trial materials.
  
  

Qualifications

• BS or MS degree in biological sciences, biotechnology, biochemistry or related fields with 3 or 2 years’ experience, respectively, in the pharmaceutical or biotechnology fields.
• Strong knowledge of mammalian cell cultures and concepts of cell metabolism, protein production, and characterization.
• Strong 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); Sartorius STR experience preferred.
• Strong knowledge and skill in using equipment for determining cell counts and cell metabolism.
• Strong knowledge and experience with single-use technologies.
• Strong 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.
• Practical experience of 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.
• Ability to work effectively in a team environment and motivated to work on multiple and various tasks, when required.
• Skill with Microsoft Office suite.
• 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.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.