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Manufacturing Operations Manager
2 months ago
Position Title: Manufacturing Operations Manager
Salary: Competitive
Summary:
The Manufacturing Operations Manager plays a crucial role in overseeing production processes and ensuring compliance with safety and quality standards. This position involves managing teams dedicated to achieving production goals while fostering a culture of continuous improvement and operational excellence.
Work Schedule:
Shifts available include:
- Shift A: Sunday to Tuesday, 6:00 PM – 6:30 AM (Week 1); Sunday to Wednesday, 6:00 PM – 5:30 AM (Week 2)
- Shift B: Wednesday to Saturday, 6:00 PM – 5:30 AM (Week 1); Thursday to Saturday, 6:00 PM – 6:30 AM (Week 2)
Key Responsibilities:
- Lead the Manufacturing Operations team to support production and strategic objectives.
- Develop and implement manufacturing schedules to meet targets, ensuring resource optimization.
- Conduct investigations related to manufacturing processes and approve necessary deviations and corrective actions.
- Identify and implement continuous improvement initiatives to enhance operational efficiency.
- Ensure timely closure of batch-related documentation to facilitate batch release.
- Maintain a comprehensive training program to ensure effective onboarding and skill development.
- Participate in audits and respond to observations in accordance with established procedures.
- Provide monthly metrics on manufacturing performance and operational health.
- Manage personnel actions including recruitment, performance evaluations, and staff development.
- Foster a culture of mentorship and continuous improvement among team members.
- Ensure compliance with quality standards and regulatory requirements.
- Adhere to safety protocols and company policies.
- Perform additional duties as assigned.
Travel Requirements:
Occasional travel may be necessary based on business needs.
Qualifications:
- Bachelor's degree in a relevant field or equivalent experience.
- Proven knowledge of aseptic processing and GMP regulations.
- Strong project management and communication skills.
- Experience in leading training and development initiatives.
- Ability to thrive in a fast-paced environment and adapt to changing priorities.
- Proficient in building relationships and managing diverse teams.
Preferred Qualifications:
- 3+ years of experience in biopharmaceutical GMP manufacturing.
- Background in cell culture and cleanroom operations.
- 5-10 years of experience in a leadership role within a manufacturing setting.
- Familiarity with FDA regulations and GxP best practices.
Physical and Mental Requirements:
- Ability to perform tasks in a cleanroom environment.
- Capable of lifting and carrying up to 45 pounds.
- Strong analytical and problem-solving skills.
Work Environment:
- Combination of office and laboratory settings with potential exposure to biohazards and chemicals.
Iovance Biotherapeutics Inc is committed to fostering a diverse and inclusive workplace. We are an equal opportunity employer and welcome applications from all qualified individuals.
