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Manufacturing Director

4 months ago

WinstonSalem, United States Klein Hersh Full time

Our client is a privately-owned contract development and manufacturing organization (CDMO) focused on helping clients from pre-clinical to development and commercialization of biologics, medical devices, and combination drugs.

The Manufacturing Director position is responsible for all aspects of manufacturing (bio-tech industry) for the company. Accountabilities include initiation, design, scheduling, management, and performance of manufacturing projects. Manufacturing projects span multiple disciplines including, but not limited to, process development, material sourcing, manufacturing material sourcing, manufacturing activities, costing activities of ongoing projects, and interaction/compliance with appropriate regulatory authorities as needed.

Key Responsibilities Problem Solving and Participation

Define, implement, and maintain project management methodology in support of manufacturing projects with a focus on the company's objectives and deliverables.

Lead manufacturing team EOS meetings and work with team to Identify, Discuss and Solve (IDS) any Issues.

Provide coordination, scheduling, oversight, management, and performance of manufacturing projects.

Process and analyze manufacturing results, data and provide appropriate status updates to Novex Executives.

Participate with product translation and quality teams, GMP resources, and other external resources and stakeholders to define project tasks and coordinate timelines.

Support IND filings with manufacturing data, as assigned.

Participate as an active team member within the larger project team.

Establish and maintain positive relationships with external partners and project stakeholders for the benefit of the company and the completion of project deliverables.

Provide regular updates on manufacturing progress to executives and other team members in a manner and at a level that resources from various backgrounds and experience levels can comprehend.

Identify ways to improve and promote quality and efficiencies in processes and products.

Problem Solving and Participation

Understand risks and issues related to manufacturing activities and, where appropriate, provide input and guidance toward potential solutions.

Use initiative and creativity to identify opportunities to extend the manufacturing services product portfolio.

Use experience to analyze and interpret project data and draw conclusions on the outcomes understanding impacts to project plan and timeline.

Contribute to collaborative decision making with colleagues in areas of manufacturing services and other efforts.

Participate in decisions that affect the work of the team and success of the project.

Analyze alternative courses of direction for manufacturing services offerings.

Maintain awareness of risks within the work environment.

Address problems that may affect the achievement of manufacturing services objectives, project deliverables and other deadlines

Financial Management

Develop budgets for manufacturing operations and assigned responsibilities.

Use projections on spend to ensure a positive budgetary outcomes.

Establish and maintain operating budgets.

Evaluate grant opportunities for specific projects.

Talent Development

Build and lead a high-performing manufacturing team, fostering a culture of innovation, collaboration, and accountability.

Accountable for leading, managing and supervising teams of laboratory technicians across multiple scientific disciplines including biologics, pharmaceuticals and medical devices.

Attract, retain, and develop top talent throughout the manufacturing areas.

Operational Excellence

Oversee all aspects of the company's operations, ensuring efficiency, quality, and compliance with industry standards and regulations.

Stakeholder Communication

Maintain effective communication with the Executive Team, shareholders, and other stakeholders, providing regular updates on company performance and strategic initiatives.

Key Requirements

A bachelor's degree in a relevant field is required as a strong scientific foundation (e.g. molecular biology, engineering, biochemistry, pharmacology) is required for the position. An advanced degree (Ph.D./MD/MBA) is preferred.

A proven track record of leadership and success in biotechnology, pharmaceutical, or related industries, with at least 10 years of executive-level experience in a CDMO or related organization.

Regulatory and cGMP experience required, minimum 10 years in the drug or biological industries preferred.

Demonstrated leadership of a manufacturing workforce group.

Demonstrated ability to work with individuals with various levels of education.

Extensive experience in strategic planning, scheduling, and operational management in a CDMO or related organization.

Strong financial acumen with a demonstrated successful history of managing financial performance.

Exceptional interpersonal and communication skills, with the ability to build and maintain strong relationships with clients, employees, and stakeholders.

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