Sr Associate, Process Development - Downstream

Abzena; San Diego (CA); On-site; USD 120,000 - 180,000; Full time

Job summary

Abzena is seeking a Senior Associate to guide Process Development (PD) work, supervising PD Associates and junior staff to support scientists in developing scalable processes on accelerated timelines.

You will lead process development activities, drive tech transfers with Cell Line Development and MSAT/MFG, and contribute to cGMP-scale scale-up while ensuring data quality and client satisfaction.

Qualifications

• BS or MS in biological sciences or related field with 6+ (BS) or 4+ (MS) years in pharma/biotech.
• Advanced knowledge of recombinant protein expression and purification via chromatography.
• Strong knowledge of protein chemistry and analytical methods.
• Hands-on experience with AKTA systems and Unicorn software (GE-Pure, Avant, Pilot, Ready).
• Experience with centrifugation, depth filtration, and tangential flow filtration (TFF).
• Knowledge of buffer formulation.
• Ability to follow instructions with minimal supervision and maintain records.
• Practical experience with cGMP manufacturing operations; regulatory familiarity is valued.
• Leadership, time management, and planning skills.
• Proficiency with MS Office; problem solving and troubleshooting.
• Safe operation of production equipment.

Responsibilities

• Designs and executes process development experiments; analyzes results and plans follow-up tests.
• Provides training to new personnel in technical processes.
• Leads process development activities and collaborates with other departments.
• Leads technical transfer of downstream processes between PD and other groups.
• Performs scale-up calculations up to cGMP scale.
• Develops buffer formulations and prepares buffers per protocols.
• Documents observations and collects data for analysis; writes reports.
• Interfaces with clients to oversee development from start to finish.
• Oversees junior personnel and ensures PD lab requirements are met.
• Travels between sites and to conferences to train on new technologies.
• Assists with protein production under cGMP standards for clinical materials.

Skills

AKTA systems

Unicorn software

Leadership

Data management

Time management

Education

BS or MS in biological sciences/related field

Tools

AKTA systems

Unicorn software (GE-Pure/Avant/Pilot/Ready)

Job description

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 Senior Associate guides and oversees the work of the Process Development (PD) Associates and junior personnel to support Scientists in the development of 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.
• 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 Cell Line Development and MSAT/MFG.
• Leads efforts 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.
• Documents observations and collects data for analysis.
• Participates in data management and the identification of trends in data and the notification of scientists of possible impacts to processes and products.
• Conducts activities in support of production schedules and objectives as directed by senior staff.
• Independently writes study protocols, experimental designs, technical transfer reports and development reports.
• 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, scheduled cleanings, 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 expression and 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

1. Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
2. Frequently lift and or move objects up to 30 pounds.
3. Stand/walk during entire length of shift.
4. Use arms, hands and fingers to handle, feel or reach.
5. Ability to climb, balance, stoop, kneel, crouch, or crawl.
6. Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.

FLSA: 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.