Director Of Manufacturing Jobs

: Director of Manufacturing (Pharmaceutical)

Location: Greater Boston Area

Position Overview:

As the Director of Manufacturing, you will be responsible for overseeing and managing the entire manufacturing process of our pharmaceutical products. Your primary focus will be ensuring the efficient and compliant production of drug products in accordance with regulatory guidelines and industry best practices. You will lead a team of manufacturing professionals, optimize production processes, and contribute to the overall success of our organization.

Responsibilities:

Leadership and Strategy:

• Provide strategic direction and guidance to the manufacturing team, ensuring all activities are aligned with business objectives.
• Foster a culture of continuous improvement, innovation, and operational excellence within the manufacturing department.
• Develop and implement manufacturing strategies aligned with the company's goals and objectives.

Manufacturing Operations:

• Collaborate with cross-functional teams, including R&D, quality assurance, supply chain, and engineering, to streamline manufacturing operations.
• Oversee all aspects of drug product manufacturing, including planning, scheduling, and execution.
• Optimize manufacturing processes, identifying areas for improvement and implementing efficiency-enhancing initiatives.
• Ensure compliance with regulatory requirements (FDA, cGMP, etc.) and internal quality standards.

Team Management:

• Set clear performance expectations, provide regular feedback, and conduct performance evaluations.
• Foster a collaborative and inclusive work environment, promoting teamwork, accountability, and professional development.
• Recruit, train, and mentor a high-performing manufacturing team.

Quality Assurance and Compliance:

• Collaborate closely with the quality assurance team to address any deviations, investigations, and CAPAs.
• Ensure adherence to cGMP and other regulatory standards throughout the manufacturing process.
• Lead and support audits and inspections, both internal and external.

Continuous Improvement:

• Drive initiatives for automation, digitalization, and advanced manufacturing technologies.
• Implement Lean Six Sigma methodologies to streamline operations and minimize waste.
• Identify opportunities for process optimization, cost reduction, and increased efficiency.

Qualifications:

• Strong leadership abilities, with the capability to motivate and inspire a diverse workforce.
• Prior experience with manufacturing automation and digitalization initiatives is a plus.
• Significant experience (10+ years) in pharmaceutical manufacturing, with a focus on drug product manufacturing.
• Bachelor's or Master's degree in pharmaceutical sciences, chemical engineering, or a related field.
• Outstanding communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams and stakeholders.
• Strong understanding of pharmaceutical manufacturing processes and equipment.
• Proven track record of successfully managing and leading manufacturing teams.
• Excellent problem-solving skills, with the ability to analyze complex situations and implement effective solutions.
• Demonstrated experience in process optimization and continuous improvement methodologies (e.g., Lean Six Sigma).
• In-depth knowledge of cGMP regulations and FDA guidelines.