Process Development Associate II

KBI Biopharma, Inc.; Durham (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

KBI Biopharma, Inc. is seeking a Downstream Process Development Associate II to support and execute laboratory studies within the Downstream Process Development organization. The role involves conducting experiments on downstream unit operations, sampling and analyzing process data, and drafting technical documentation under supervision.

The candidate should hold a B.S. degree with 2+ years of experience or an M.S.

Qualifications

• B.S. degree and 2+ years experience or an M.S. degree.
• Excellent written and verbal communication skills with strong client deadline focus.
• Flexibility of hours to support downstream processes.
• Knowledge of GMPs and biotechnology-derived product regulations preferred.

Responsibilities

• Conduct laboratory experiments in downstream process development including setting up and running unit operations.
• Operate downstream unit operations (chromatography, tangential flow filtration, clarification, filtration).
• Sample and perform basic analysis of process samples (pH, conductivity, concentration).
• Observe, analyze data and troubleshoot unexpected results with peer/input from management.
• Compile data and contribute to templated technical documents.

Skills

Laboratory techniques

Chromatography

Filtration

Data analysis

Documentation

Education

B.S. degree

M.S. degree

Job description

Position Summary

The Downstream Process Development Associate II supports and executes laboratory studies within the KBI Biopharma (KBI) Downstream Process Development organization under general supervision.

Position Responsibilities

• Conducts laboratory experiments in support of downstream/drug substance process development including preparing solutions, running downstream unit operations (chromatography, tangential flow filtration, clarification, normal filtration, etc.), sampling and executing basic analysis of process samples (concentration, pH, conductivity, etc.).
• Exercises judgment within defined procedures and practices to determine appropriate action (sometimes called upon to exercise judgment outside of defined procedures).
• Observes and analyzes data resulting from executed experiments; identifies and troubleshoots unexpected results with input and/or review from peers or management.
• Compiles data and contributes to drafting of templated technical documents.
• May contribute to client presentation development and may interact with clients.
• May contribute to the evaluation, development and implementation of new downstream technologies leading to process improvements and efficiency of operation in support of downstream process development and manufacturing activities.
• Documents procedures, observations, and results in laboratory notebooks and responsible for maintaining training compliance, according to site expectation.
• Reviews documentation and records as assigned.
• Contributes to general lab maintenance and operation excellence initiatives in accordance with internal guidance.
• Assures proper labeling, handling, and storage of all chemicals used in the area; assures proper labeling and disposition of hazardous waste in satellite areas; adheres to all safety requirements and follows safe procedures, and attends all required safety and health training, including handling hazardous waste.
• Reacts to change productively and handles other essential tasks as assigned.

Minimum Requirements

• Process Development Associate II requires a B.S. degree and 2+ years experience or a M.S. degree.
• Excellent written and verbal communication skills, focus on customer service, and ability to meet strict client deadlines.
• Flexibility of hours to support downstream processes.
• Knowledge of GMPs and biotechnology-derived product regulations preferred.

KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force. Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

At KBI, we are constantly seeking to improve our team with accomplished individuals who share in our commitment to serve our clients as they seek to advance important medicines to the patients who need them.

We offer our employees a challenging, rewarding and fast-paced environment along with the opportunity for career advancement through the development of one’s technical skills.

At KBI, employees work in a collaborative, team environment, where sharing knowledge and expertise with one another is strongly encouraged.