KYDA Partners is looking for a Production Manager for a growing Biotechnology company. Reporting to the Director, you will oversee human tissue manufacturing and supervise employees and activities on your assigned shift. The immediate need is Monday-Friday 4pm-Midnight.
Key Responsibilities:
- Ensure compliance with FDA 21 CFR 1271, AATB standards, cGTP, GDP, and industry standards.
- Maintain expertise in aseptic techniques and sterile fields.
- Supervise HCT/P production personnel and activities across various shifts, including weekend overtime.
- Manufacture human tissue products using aseptic techniques per SOPs.
- Optimize manufacturing yield based on production plans.
- Oversee cleanroom and equipment maintenance, calibration, and validation.
- Document manufacturing processes and tasks accurately and concurrently.
- Act as departmental liaison in the Director's absence.
- Manage sterilization of reusable supplies and production support activities.
- Identify, address, and escalate risks/issues and nonconformances.
- Support investigations into deviations/nonconformances and CAPA as a subject matter expert.
- Conduct and supervise employee training in production procedures.
- Develop, revise, and maintain procedures in line with FDA and AATB regulations.
- Provide after-hours or on-call support for environmental monitoring alarms and emergencies.
- Build and maintain relationships with stakeholders, vendors, customers, and employees.
- Attend training sessions to maintain competency.
- Manage production scheduling to meet forecasts.
Education & Experience:
- Bachelor’s degree or equivalent required.
- CTBS Certification preferred.
- 5+ years of hands-on experience in aseptic or sterile environments.
- 5+ years of experience in an FDA-regulated HCT/P manufacturing environment.
- Valid Class “C” driver’s license required.
