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Site Director
Hikma PharmaceuticalsSite Director providing strategic leadership at Bedford site for Hikma Pharmaceuticals. Responsible for overseeing manufacturing, quality, and supply chain operations to ensure compliance and efficiency.
About the role
Key responsibilities & impact- 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
What you’ll need- 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
Comp & perks- 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
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
sterile manufacturinginjectable manufacturingIV bag production processesFDA compliancecGMP compliancemanufacturing processesdata analysisfinancial reportingpreventative maintenanceprocess improvements
Soft Skills
leadershipteamworkproblem solvingcommunicationinfluencingjudgmentcross functional alignmentinterpersonal skillscapacity managementcustomer interaction
Certifications
BS in EngineeringMS in Engineering or related fieldFDA regulations knowledgecGMP training