Research Associate II, Process Development

Laboratory Technical Competency Ensures laboratory has all relevant supplies, equipment, reagents, and inventory while maintaining and improving workspace organization and cleanliness Performs laboratory activities supporting process development programs for pharmaceutical and biotechnology products within a contract development and manufacturing (CDMO) environment. Seeks to collaboratively solve laboratory, manufacturing support, and process development challenges using established laboratory procedures, professional concepts, company policies, and scientific principles.

Plans and executes moderate to complex laboratory experiments, process evaluations, sample preparation, solution preparation, equipment setup, and process development studies in accordance with approved protocols and procedures. Operates, calibrates, maintains, and performs troubleshooting of laboratory equipment while initiating and documenting maintenance activities as required Identifies and communicates opportunities to improve laboratory efficiency by recommending enhancements to existing procedures and laboratory practices within established guidelines Quality Competency Maintains accurate laboratory notebooks, electronic laboratory records, calculations, and technical documentation in accordance with Good Documentation Practices (GDP) and company procedures.

Maintains compliance with company policies, safety procedures, current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), laboratory procedures, and applicable regulatory requirements. Analyzes experimental data, evaluates results, identifies routine trends, and communicates technical summaries to support process development activities and project objectives. Manufacturing Technical

Competency:

Executes process development studies and provides technical input to support process optimization, process characterization, technology transfer activities, change in scale activities, manufacturing support, and continuous improvement initiatives. Maintains relevant process development supplies, equipment, reagents, and inventory while ensuring workspace organization and cleanliness. Interpersonal

Competency:

Provides guidance and training to less experienced laboratory personnel on routine laboratory techniques, equipment operation, documentation practices, and standard operating procedures. Collaborates with internal colleagues to support development programs and project timelines Process Development, Analytical Development, Manufacturing, Quality Control, Quality Assurance, Engineering, Project Management and other cross-functional teams. Business Process

Competency:

Identifies and communicates observations, technical findings, experimental results, and project updates to enable completion of Project Management goals, milestones, communications, and deliverables. Maintains confidentiality of proprietary, customer, and company information.
* Performs other duties as assigned.

Requires a minimum of two (2) years of related manufacturing, laboratory, graduate research, or process development experience. Exposure to synthetic, purification, or bioprocessing equipment and analytical instrumentation is recommended. Undergraduate degree, or industrial experience in a Technical Field. Recommended exposure to Life Sciences, or a related scientific discipline. Chemical Engineering, Biochemical Engineering, Biomedical Engineering Chemistry, Biology, Biochemistry, Materials Science Process Technology, Biotechnology, Chemical Engineering Technology, Experience supporting pharmaceutical, biotechnology, life sciences, CDMO, academic research, or other regulated laboratory or manufacturing environments is valued.

Intermediate knowledge of laboratory techniques, scientific principles, experimental design, data collection and analysis, laboratory instrumentation, and process development methodologies. Intermediate knowledge of current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), laboratory safety requirements, and scientific documentation standards. Demonstrated ability to independently execute laboratory experiments, analyze experimental data, identify routine trends, troubleshoot laboratory issues, and support process development activities. Experience operating laboratory instrumentation and maintaining accurate laboratory documentation in electronic and paper-based systems.

Strong…