Research Associate II, Process Development (2026-034-106)

Gannet BioChem; Huntsville (AL); On-site; USD 60,000 - 90,000; Full time

Job summary

Gannet BioChem in Huntsville, AL, is looking for a Laboratory Scientist to support process development for pharmaceutical and biotechnology products within a CDMO environment. You will plan and execute lab experiments, characterize processes, and prepare technical documentation.

The role involves equipment operation, maintenance, and collaboration with cross-functional teams to meet project milestones. The ideal candidate has at least two years in manufacturing or lab roles, with exposure to

Qualifications

• Minimum two years of related manufacturing, laboratory, or process development experience.
• Experience in pharmaceutical/biotech lab environments is valued.
• Ability to independently execute laboratory experiments and document results.
• Knowledge of cGMP and GDP is preferred.

Responsibilities

• Plan and execute moderate to complex laboratory experiments and process development studies.
• Operate, calibrate, maintain, and troubleshoot laboratory equipment and document maintenance.
• Provide guidance and training to less experienced staff on routine techniques and SOPs.
• Collaborate with cross-functional teams to support development programs and project timelines.

Skills

Laboratory techniques

Data analysis

Experimental design

Process development

Troubleshooting

Education

Undergraduate degree in a technical field

Experience in Life Sciences or related discipline

Job description

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.

II. Minimum Qualification Requirements

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 manage multiple laboratory assignments while meeting project timelines. Effective written and verbal communication skills with the ability to prepare technical documentation, communicate experimental observations, and provide guidance on routine laboratory procedures. * Ability to maintain confidentiality and comply with company policies and applicable regulatory requirements.

III. Physical Requirements

Must be able to pass pre-employment drug screening and background check for employment consideration. Must be able to lift 25 lbs. Must be able to sit or stand for long periods of time. Employees must be able to wear a respiratory protection (filtering face piece, ½ face, full-face, or powered air purifying respirator, supplied air, or self-contained breathing apparatus) for certain tasks essential to the job function. Employees must be able to gain access to elevated work surfaces via vertical ladders or stairs to perform tasks essential to the job function. Employees performing visual inspection of primary packaging (e.g., vials and particulates) must be able to accurately detect color and have 20/20 vision, with or without corrective lenses.