Director, Operations

Work Schedule

Environmental Conditions

Job Description

This is a key leadership position that will drive global manufacturing sites in Detroit and Miami for GMP production of cell culture products including cell culture media and peptones for use in biopharmaceutical manufacturing and research. This position will report directly to the Vice President, Divisional Operations Leader. This role is focused on meeting customer needs in a fast paced cGMP environment, leading and ensuring all functions at the sites are functioning at peak efficiency with proper internal communication and interfaces, developing the operations and manufacturing teams while ensuring delivery of high quality products which are in compliance with all applicable cGMP manufacturing regulations.

What will you do:

• Develop and establish strong operating mechanisms to ensure business objectives are met while encouraging a collaborative culture across manufacturing sites.

• Cascade operational strategies, goals, and objectives with a strong execution approach aligned with the business and global Ops team.

• Coordinate the hiring, training, mentoring, and performance reviews of team members, guiding them to be outstanding players.

• Apply prioritization mechanisms to distribute resources among teams to successfully complete the necessary workload.

• Lead site leadership across functions to achieve business unit goals.

• Drive compliance with applicable US FDA and EC Quality System Regulations.

• Establish key performance indicators, track, trend, and supervise routinely with active data analysis to target and achieve results.

• Coordinate the development and timely implementation of corrective steps (CAPA) when required.

• Manage budgets, schedules, and key operating metrics.

• Define clear objectives and expectations, providing direct feedback for performance management.

• Identify projects and recommend appropriate actions to increase profitability and supply.

• Implement robust Risk Management practices to ensure high project success rates.

How will you get here:

Education

• Bachelor's degree required in a related field; Master’s Degree preferred.

Experience

• Minimum of 7+ years of management experience in a sophisticated manufacturing environment.

• Strong communication abilities and collaborative approach, adept at collaborating with individuals across various levels and functions to drive positive outcomes.

• Strong leadership ability, capable of using diverse resources, responding quickly, and understanding the impact of changes and decisions.

• Practical application experience in continuous improvement methodologies to improve processes, strengthen quality, and drive efficiency.

• Strong analytical ability to effectively use data in problem-solving and evaluate process changes.

• Ability to partner with and influence key team members, including Finance, R&D, Product Management, and the Commercial team.

• Experience in leading multiple complex projects concurrently while meeting target dates.

• Larger site leadership experience in a matrix organization applying influential skills to achieve desired outcomes.

• Experience in a cGMP environment with a focus on Make to Order (MTO)/Custom products is preferred.

• Valuable audit experience within a cGMP environment with successful outcomes.

• Knowledge of P&L drivers and experience using them to achieve excellent results is beneficial.
• ​Travel up to 25%.