Manufacturing Operator (Advanced Therapies) responsible for routine manufacturing activities across GMP areas at the Lebanon Advanced Therapies, LP2 site (Cell Culture, Downstream Purification, Fill & Finish). Initially supports equipment qualification, develops site operations procedures, and sets up production areas; then executes production activities on assigned shift under the shift supervisor.
Responsibilities:
- Work in a cleanroom to produce advanced therapies safely and with quality.
- Coordinate production with Quality Control, Quality Assurance, and Plant Maintenance for on-time release.
- Participate in equipment commissioning/qualification and process validation activities.
- Safely work with BSL-2 materials per site biologics safety program.
- Produce and document batches using digital batch records and applicable SOPs.
- Utilize/monitor manufacturing equipment to meet performance and safety standards.
- Collaborate with maintenance/QA to ensure equipment is validated for use.
- Provide clear verbal and written reports.
- Maintain accurate electronic records/logbooks per cGLP/cGMP.
- Adhere to all procedures, cGLP/cGMPs, and quality/regulatory requirements; follow cleanroom gowning requirements.
- Work well in a fast-paced team environment.
Minimum Requirements:
- High school diploma or equivalent.
- Direct manufacturing experience with automatic, manual, and semi-automated equipment following procedures.
- Authorization to work in the United States full-time; no visa sponsorship.
Additional Preferences:
- 3+ years pharmaceutical cleanroom experience.
- Drug Substance experience (bioreactors, Sums, TFFs, purification).
- Technical problem-solving, strong oral/written communication, attention to detail, organization.
- Ability to learn GMP and digital systems; support safety/environmental compliance.
Other:
- Start-up primarily day shift; later rotating 4 x 10-hour shifts; some overtime; focus on complex tasks 4β6 hours.
Benefits/Compensation:
- Wage: $17.30β$34.38; may be eligible for company bonus; comprehensive benefits including 401(k), medical/dental/vision, flexible spending, life insurance, time off/leave, and well-being benefits.