Process Development Associate

Job Title:

Process Development Associate

Job Description

This role focuses on supporting purification process development for clinical and commercial programs by performing high-throughput purification experiments, maintaining laboratory equipment, and analyzing data to generate process insights. The Process Development Associate works in a fast-paced pilot-scale laboratory to help scale purification processes and support downstream development activities.

Responsibilities

+ Perform high-throughput purification screening experiments to support purification process development for clinical and commercial processes.

+ Support laboratory work related to purification of various biological molecules, including proteins and other biomolecules.

+ Document experiments, results, and conclusions accurately and promptly in an electronic laboratory notebook.

+ Maintain laboratory instruments, including setup, calibration, and routine upkeep, to ensure reliable and consistent operation.

+ Troubleshoot instrumental and experimental issues and implement corrective actions to minimize downtime.

+ Collect, aggregate, and organize historical process and experimental data from multiple sources.

+ Analyze historical and current experimental data to generate insights that inform purification process development and optimization.

+ Contribute to downstream processing and purification development activities, including scale-up and technology transfer tasks.

+ Collaborate with a broader process development team to support project timelines and deliverables while taking ownership of individual assignments.

+ Follow established laboratory procedures, safety guidelines, and documentation standards to ensure data integrity and compliance.

+ Assist with automation-related tasks, such as operating or supporting TECAN or similar platforms, where applicable.

Essential Skills

+ Bachelor's and/or Master's degree in Chemical Engineering, Biochemical Engineering, Biochemistry, or a related scientific field of study.

+ 0-3 years of experience in the biotechnology or pharmaceutical industry.

+ Hands-on experience or training in protein purification and downstream processing techniques.

+ Fundamental understanding of column chromatography principles and their application to protein purification.

+

Experience with or exposure to AKTA systems (such as AKTA Pilot or AKTA Process) for purification operations.

+ Ability to perform and document experiments in an electronic laboratory notebook with a high level of accuracy and detail.

+ Capability to maintain and troubleshoot laboratory instruments used in purification and downstream processing.

+ Ability to collect, aggregate, and analyze experimental and historical data to draw meaningful conclusions.

+ Strong teamwork skills with the ability to work effectively in a collaborative process development environment while managing individual responsibilities.

Additional

Skills & Qualifications

+

Experience with downstream development activities, including scale-up of purification processes.

+ Exposure to or experience with automation platforms such as TECAN.

+ Knowledge of technology transfer principles related to purification and downstream processes.

+ Experience working with tangential flow filtration (TFF) or similar downstream unit operations.

+ Strong fundamental understanding of various protein purification principles and their application to clinical and commercial processes.

+ Interest in working in a fast-paced pilot-scale laboratory environment focused on sound science and continuous improvement.

+ Motivation to grow within an expanding organization that offers long-term career development opportunities.

+ Eligibility for comprehensive benefits packages, including potential stock options or equity, bonuses, restricted stock units (RSUs), and retirement plan matching for full-time employees, as applicable.

+ For contract roles, eligibility for accrued sick time, accrued vacation time, and paid holidays as observed by the organization, where applicable.

Work Environment

The role is part of a small team within a larger process development group of approximately 50 people, focused on process development and…