Site Director

Role Overview

• Regular and predictable onsite attendance and punctuality.
• Overall oversight of all operations for Bedford site, including Manufacturing, Supply Chain, Engineering and Maintenance.
• Includes IV Bag and Lyophilization manufacturing, including batching, filling, inspection and packaging.
• Optimize throughput, efficiency, labor utilization and capacity to meet demand forecast and customer needs.
• Matrix reporting structure including Quality Assurance, Quality Compliance, Finance and Human Resources to drive cross functional alignment at the Bedford manufacturing facility.
• Responsible for the outgoing quality, safety and efficacy of all finished product, compliance with all applicable specifications, Standard Operating Procedures, FDA regulations (GMP’s) and New Drug Applications.
• Supports the execution of preventative maintenance, calibration program, process improvements and technology upgrades and related Engineering projects to enhance productivity and quality.
• Lead Supply Chain planning, procurement, production scheduling, material management and inventory control to support plant operations to meet monthly and annual Sales Forecast.
• Ensure effective Operations and Quality controls are in place to meet sterile manufacturing requirements.
• Oversee capital project planning, site budgets, site manufacturing schedules and performance requirements are met.
• Improves product quality and cost and reduces customer complaints through a proactive program that includes interaction with internal and external suppliers.
• Utilizes collected data from customers to enhance perceived product quality.
• Adheres to all environmental, health and safety SOP’s, equipment, policies and procedures, including any department specific requirements.
• Responsible for resolving complex problems where analysis of situations or data requires an in-depth evaluation of multiple factors.
• Must execute judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Regularly interacts with senior management or executive levels on matters concerning several functional areas, division, and/or customers.
• Establishes and maintains an environment that stresses and encourages teamwork.
• Provides leadership in Lean culture.

Requirements

• BS in Engineering, Life Sciences, or related field; MS preferred
• 5+ years sterile/injectable manufacturing experience
• 5+ years experience leading and managing a team
• Up to 3 years experience with FDA/cGMP compliance and sterile manufacturing practices
• Strong knowledge of IV bag production processes and equipment
• Manufacturing experience of 8 to 10 years
• Strong leadership presences with the ability to influence across functions.
• Ability to manage activities of departments through subordinate managers who exercise full supervision in terms of cost, methods, and employees.
• Ability to interpret and analyze statistical data and financial reports, understand and resolve technical difficulties, interface with internal engineering/technical experts and external technical representatives, and manage multiple priorities in a manufacturing environment setting.
• Intermediate software application skills required.
• Strong interpersonal, problem solving, and communication skills are required.

Benefits

• Annual performance bonus, commission, and share potential
• Auto enrollment in a Hikma-sponsored 401(k) program at a pre-tax contribution rate of 3% of eligible pay.
• Hikma will match 100% of the first 6% of eligible pay that you contribute
• A generous paid time off (PTO) bank starting with 20 days (prorated based on hire date).
• Additional days granted upon reaching work milestone anniversaries
• 3 personal days (prorated based on hire date)
• 11 company paid holidays
• Comprehensive benefits including health, dental, vision, mental health, disability, life insurance, prescription drug coverage, and a variety of voluntary benefits
• Employee discount program
• Wellbeing rewards program
• Safety and Quality is a top organizational priority
• Career advancement and growth opportunities
• Tuition reimbursement
• Paid maternity and parental leave