Job Details

Job Title:Director, Manufacturing

Job Number: 36680

Location: Hercules,CA

Job Description

Our client is targeting an established Director of Manufacturing. In the role, this professional will work across Manufacturing Operations to ensure goals and KPIs are being met in their internal environment. Not only will you work cross functionally across MSAT/QA/Operations/related departments, you will also lead a team of 5+ direct reports.

Responsibilities

• Directly oversee the manufacturing of companies product inventory
• Ensure compliance with worldwide regulatory requirements.
• Establish cost reduction programs to lower costs, reduce inventory, and improve quality
• Proactively identify knowledge gaps and risks, and work with the team to develop mitigation plans
• Oversee supply chain activities to ensure critical raw materials, reagents and other inventory is made available to ensure timely execution of manufacturing campaigns
• Develop manufacturing plans with resources and supervise schedules to meet demand
• Evaluate new technologies and novel, relevant applications of existing technologies for potential implementation to improve company's products and processes
• Identify and implement process improvement opportunities and/or corrective actions to increase yield, maximize capacity, improve operational efficiency, reduce costs, and ensure safety while maintaining regulatory compliance
• Work closely with Quality department to ensure compliance with cGMP, ICH and FDA regulations
• Creates and/or oversee quality and continuous improvement activities utilizing quality tools and systems such as Lean, Six Sigma, and 5S
• Define and communicate strategic imperatives to project success
• Ensure clear communication to Company's senior management on the status of inventory, manufacturing projects and goals as they relate to cross-functional business success
• Perform other such duties as may be assigned to you

Required Skills

• 15+ years of hands-on manufacturing experience in pharmaceutical/biotech industry
• 10+ years of direct management of manufacturing professionals with a range of responsibilities
• Exceptional communication and interpersonal skills
• Ability to collect and analyze data and information to determine paths for process improvement and potential root cause
• Demonstrated critical thinking and problem-solving skills
• Must have full working knowledge of cGMP regulations