Process Development Associate

Job Title:

Process Development Associate

Job Description

This role seeks an enthusiastic, highly motivated, and team-oriented Process Development Associate with a strong background in cell culture. You will perform viral clearance studies for biological products in close collaboration with downstream partners, working alongside a team of talented scientists. The position focuses on executing cell culture activities, supporting documentation review and updates, and contributing to integrated digital data capture and analysis.

You will work independently within digital documentation systems and represent the biosafety development function in scientific and cross-functional meetings, interfacing directly with partner organizations.

Responsibilities

+ Support the biosafety development team in the completion of viral clearance studies for biological products.

+ Perform cell culture maintenance and related support activities, ensuring high-quality and consistent experimental conditions.

+ Execute hands-on cell culture techniques as part of viral clearance study workflows.

+ Review, update, and maintain documentation, including standard operating procedures (SOPs) and study records.

+ Make standardized revisions to SOPs to improve clarity, consistency, and alignment with evolving work streams.

+ Contribute to the evolution and optimization of data analysis workflows related to viral clearance studies.

+ Assist with data analysis and data clean-up activities, ensuring accuracy and integrity of study data.

+ Use integrated digital documentation and next-generation data capture systems to record, track, and analyze experimental data.

+ Communicate effectively with cross-functional teams and external partners to coordinate study activities and share results.

+ Represent the biosafety development team in scientific and cross-functional meetings, providing clear technical updates and insights.

+ Collaborate closely with downstream process partners to align viral clearance studies with broader development goals.

+ Maintain a detail-oriented approach to experimental work, documentation, and reporting to support regulatory and quality expectations.

Essential Skills

+ Bachelor's degree in a scientific discipline such as chemistry, biochemistry, cell biology, or a closely related field.

+ Approximately 2 years of experience in chemistry, biochemistry, cell biology, or related scientific work.

+ Strong practical cell culture skills, including routine maintenance and execution of cell-based experiments.

+ Hands-on experience with cell culture techniques used in biological product development or biosafety studies.

+ Ability to work independently while using integrated digital documentation systems.

+ Experience performing data analysis and data clean-up, with a focus on accuracy and reliability (not in a data scientist capacity).

+ Advanced scientific and technical reading and writing skills to interpret protocols, reports, and scientific literature.

+ Excellent communication skills, with the ability to convey complex scientific information clearly to cross-functional teams.

+ Demonstrated ability to collaborate effectively and work well in teams in a laboratory or development environment.

+ Strong attention to detail in experimental execution, documentation, and data review.

Additional

Skills & Qualifications

+

Experience with next-generation data capture systems and digital data analysis tools.

+ Familiarity with improving and standardizing SOPs and documentation processes.

+ Comfort representing a scientific team in cross-functional and client-facing meetings.

+ Strong organizational skills to manage multiple studies and documentation tasks simultaneously.

+ Ability to adapt to evolving workflows and contribute ideas to optimize viral clearance and data analysis processes.

Work Environment

This position operates in a collaborative scientific and laboratory-based environment focused on biosafety and viral clearance for biological products. You will work closely with a team of scientists and downstream partners, using integrated digital documentation platforms and next-generation data capture systems to support studies and data analysis.…