Director of Sterile Injectable Manufacturing - Pharmaceutical Industry

COMPANY

Over 30 years in business this Nationally recognized CDMO is focused on small molecule product development projects from discovery to commercialization for it s pharmaceutical partners.

OVERVIEW OF ROLE

The Director of Manufacturing Injectables serves as the functional head of operations, providing oversight of clinical & commercial production activities. This position is a key member of the site leadership team, working to execute long-term strategies and revenue achievement.

KEY EXPERIENCE AND ATTITUDE REQUIRED TO WIN IN THIS ROLE

• The right candidate should possess a boots on the ground mentality with an eagerness to connect with operators and technicians with a focus on giving them the tools to succeed.
• The right candidate should possess a strong track record of change management and process improvement with tools they have implemented in the past which drove accountability at all levels of the pharmaceutical manufacturing process.

RESPONSIBILITIES

• Implement systems, tools, and resources to ensure successful achievement of revenue related targets
• Oversight of operational aspects of manufacturing, including: productivity, cost, planning, daily business processes, cGMP compliance, and safety
• Key contributor to positive client relationships by ensuring adherence to customer requirements/specifications, open communication, and resolution of any issues
• Ensure execution of on-boarding activities and training plans
• Collaborate effectively with Master Scheduler to establish demand plan and detailed schedule, articulate key financial milestones for forecast
• Drive manufacturing technology, automation, and facility strategies through partnership with Engineering
• Lead, coach, and provide direction to direct reports, as well as indirect reporting relationships
• Management and oversight of departmental budget(s)
• Collaborate with Project Management team to ensure that operations resources are effectively deployed and meet client expectations
• Collaborate with Quality/Validation to support the validation lifecycle of all equipment, utilities, facilities, systems and processes
• Establish and track the relevant KPIs to improve the efficiency and quality of the GMP manufacturing operations
• Partner with Business Development, Project Management, R&D, and Quality Leadership teams to ensure compliance within the quality system

QUALIFICATIONS

• Bachelor's degree or higher in Engineering, Pharmaceutical Science, or a related field
• Minimum of 10 years of experience in aseptic manufacturing, preferably in the pharmaceutical or biotech industry
• Strong knowledge and understanding of cGMP, FDA regulations, and aseptic processing principles, technologies, and equipment
• Demonstrated experience in leading teams, project management, problem solving, and developing and executing operational and capital budgets
• Excellent communication, interpersonal, and leadership skills, and ability to work effectively in a cross-functional and dynamic environment
• Experience with process validation, contamination control, quality systems, and continuous improvement methodologies (e.g., Six Sigma, Lean, Kaizen, etc.)

BENEFITS

• Competitive salary and annual bonus.
• Relocation assistance.
• Medical, Dental, Vision and Life Insurance and Disability Insurance.
• 401k