Manager, Manufacturing Operations
Amneal Pharmaceuticals
8 hours ago
On-site
Piscataway, NJ
Operations
The Manager, Manufacturing Operations will be responsible for manufacturing activities including pharmacy, mixing, granulation, tablet manufacturing, encapsulation, and coating operations (including potent and hormonal areas). Ensure production runs smoothly, efficiently, and in compliance with safety and quality standards. Manage production teams, optimize workflows, and implement continuous improvement strategies to meet company and customer demands.
Essential Functions:
- Serve as Manufacturing Department representative in quality investigations (deviations, complaints, OOS issues, material disposition, change control); manage CAPA implementation and effectiveness verification; ensure compliance across manufacturing, maintenance, packaging, quality, regulatory, logistics, safety, and HR; oversee departmental audits.
- Plan and coordinate daily activities; execute management strategies; budget planning and allocation for projects to meet monthly targets; resolve technical challenges; lead investigations and provide solutions; prepare weekly/monthly reports (productivity, utilization, cGMP compliance, training status).
- Supervise, train, and motivate production staff; provide daily guidance; conduct performance reviews; promote training and skill development.
- Collaborate with Planning to manage monthly and rolling forecast needs; coordinate manufacturing priorities with QC/QA for raw material releases and sampling; implement conditional releases of APIs.
- Review daily batch records; recommend improvements; evaluate production systems and implement corrective actions; reduce cycle times and costs using Six Sigma and LEAN while maintaining/enhancing quality.
- Collaborate with MST and cross-functional teams (Operations, Regulatory, Quality, Laboratory, etc.) to implement new processes in coordination with Quality.
Additional Responsibilities:
- Other duties as assigned.
Qualifications:
- Bachelor’s degree (BA/BS) in Pharmaceutical/Manufacturing (Required)
- Master’s degree (MS/MA) in Pharmaceutical/Manufacturing (Preferred)
- 5+ years of pharmaceutical manufacturing manager-level experience (Required)
Essential Functions:
- Serve as Manufacturing Department representative in quality investigations (deviations, complaints, OOS issues, material disposition, change control); manage CAPA implementation and effectiveness verification; ensure compliance across manufacturing, maintenance, packaging, quality, regulatory, logistics, safety, and HR; oversee departmental audits.
- Plan and coordinate daily activities; execute management strategies; budget planning and allocation for projects to meet monthly targets; resolve technical challenges; lead investigations and provide solutions; prepare weekly/monthly reports (productivity, utilization, cGMP compliance, training status).
- Supervise, train, and motivate production staff; provide daily guidance; conduct performance reviews; promote training and skill development.
- Collaborate with Planning to manage monthly and rolling forecast needs; coordinate manufacturing priorities with QC/QA for raw material releases and sampling; implement conditional releases of APIs.
- Review daily batch records; recommend improvements; evaluate production systems and implement corrective actions; reduce cycle times and costs using Six Sigma and LEAN while maintaining/enhancing quality.
- Collaborate with MST and cross-functional teams (Operations, Regulatory, Quality, Laboratory, etc.) to implement new processes in coordination with Quality.
Additional Responsibilities:
- Other duties as assigned.
Qualifications:
- Bachelor’s degree (BA/BS) in Pharmaceutical/Manufacturing (Required)
- Master’s degree (MS/MA) in Pharmaceutical/Manufacturing (Preferred)
- 5+ years of pharmaceutical manufacturing manager-level experience (Required)