Research Associate II, Process Development

I. Essential Duties and Responsibilities

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 analytical, organizational, and problem-solving skills with the ability to…