Senior GMP Manufacturing Technician

Duke Careers

. Manufacture complex and specialized cellular products for clinical trials and commercial operations .

Posted 10/13/2026full-timeDurham • North Carolina • United StatesSenior💰 $61,026 - $98,439 per yearWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates expertise in cellular product manufacturing within GMP environments, adhering to GLP, GTP, and GDP guidelines while ensuring regulatory compliance. Proficient in laboratory operations, including equipment maintenance, documentation, and training of personnel.

Highest-signal resume keywords

GMP ComplianceCellular Product ManufacturingAseptic TechniqueLaboratory ExperienceDocumentation and Reporting

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Cell Separators OperationCentrifuge OperationIncubator OperationPipette UsageBiological Safety Cabinet OperationBatch Record ReviewEquipment CalibrationLaboratory Data EvaluationValidation WritingReagent Preparation

Soft Skills

Good Communication SkillsTeam CollaborationIndependent WorkAdaptability to PrioritiesRelationship Management

Industry Keywords

GMPGLPGTPGDPClean Room EnvironmentLaboratory SafetyInfection ControlUniversal PrecautionsHazardous Chemical HandlingClinical Trials

About the role

Key responsibilities & impact

Manufacture complex and specialized cellular products for clinical trials and commercial operations
Support daily GMP facility operations to maintain control and regulatory compliance
Perform clean room duties while fully gowned, following GMP guidelines and aseptic technique
Conduct cellular product manufacturing under GLP, GTP, GMP, and GDP guidelines
Operate and provide guidance on cell separators, cell counters, centrifuges, incubators, pipettes, and biological safety cabinets
Complete and review batch records, equipment logs, and GMP documentation
Maintain confidentiality and verify patient identification, specimen labeling, and specimen quality
Evaluate laboratory data and prepare accurate, timely reports with recommendations or conclusions
Write and review validations, research plans and reports, SOPs, and batch records
Maintain equipment calibration schedules and laboratory space, coordinating with contractors as needed
Troubleshoot deviations and ensure remedial actions are taken and documented
Work with laboratory management and quality assurance colleagues to maintain regulatory compliance
Participate in laboratory inspections and work with inspectors
Maintain inventory of supplies and reagents
Participate in laboratory equipment cleaning and maintenance
Train new hires and lower-level manufacturing technicians
Prepare reagents, stains, solutions, chemicals, antibodies, and culture media
Assist with technology transfer of manufacturing processes from pre-clinical to GMP environments
Perform other related duties incidental to the role

Requirements

What you’ll need

Bachelor's degree in science, engineering, or related field
Minimum of two years of laboratory experience
Laboratory experience preferably in a GMP/regulated environment
A related master's degree may substitute for two years of required experience
Good communication skills
Ability to work independently and as part of a team
Ability to work in a highly collaborative environment to complete complex tasks
Ability to manage multiple and rapidly changing priorities
Ability to quickly learn new skills and concepts
Ability to work in a clean room environment while fully gowned
Knowledge of GMP, GLP, GTP, and GDP guidelines
Knowledge of aseptic technique, laboratory safety, infection control, universal precautions, and hazardous chemical handling
Ability to maintain strong working relationships with managers, GMP team members, and departmental staff

Benefits

Comp & perks

Health insurance plans
Generous paid time off
Retirement programs with employer contributions
Tuition assistance for employees and their children
Comprehensive medical and dental care programs
Generous retirement benefits
Family-friendly and cultural programs
Inclusive culture emphasizing excellence, innovation, and discovery