Senior Director - Manufacturing - Glenmark Pharmaceuticals - Monroe

Job description
Position Summary:
Glenmark is actively seeking a Sr. Director of Manufacturing to head overall factory manufacturing processes at our new facility in Monroe, North Carolina. This will include production, warehouse activities, engineering, and liaising with government agencies and customers. The Sr. Director will ensure that start-up and ongoing operations at the plant are carried out in an effective manner with adherence to government and statutory regulations, and compliance requirements.

Key Responsibilities:
Design manufacturing processes that support business strategies adapted to changing market conditions, new business opportunities, and cost reduction strategies
Implement the company’s cGMP onsite through adequate resource and infrastructure planning
Conduct risk assessment of all plant processes and sub-processes in order to identify and reduce product failures and market complaints.
Initiate a safety management system at the plant
Develop and implement plans for plant capacity additions to ensure that growth targets are met successfully; regularly review and update capacity requirements

Ensure plant is sufficiently prepared for regulatory and customer audits
Create an effective budgeting strategy to ensure ROI on capital expenditures; balance capital expenditure budget for both short-term and long-term goals
Collaborate with other departments, such as Procurement, Engineering, and Quality Assurance, to identify and validate new plant processes
Implement high standards for Overall Equipment Effectiveness (OEE), specifically targeting Compression and Packing
Develop guidelines for material reconciliation onsite, and create strategies aimed at reducing SFG/FG batch rejection numbers

Desired Skills and Experience
Education:
Bachelor's degree in Chemistry, Engineering or Pharmacy. Master’s degree preferred.
Experience:
18-20 years of experience in pharmaceutical manufacturing, with adequate experience in injectable ops required.
5+ years of experience in plant leadership role, with direct supervisory responsibility for professional, salaried, and hourly employees
Demonstrated knowledge of plant start-up operations in a regulated environment, strongly preferred
Experience working in a facility subject to FDA regulations, and other regulatory audits
Skills:
Functional knowledge of pharmaceutical manufacturing processes
Knowledge of Technology Transfer process
Excellent leadership and communication skills
Strong technical skills, including the ability to understand all applicable process technology, equipment, unit operations, and
control technology

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