Head of Aseptic Manufacturing

Job Description

#2286z - Head of Aseptic Manufacturing

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