General Manager / Site Head

Company Overview

Morgan Prestwich is thrilled to be partnering with a rapidly growing small CDMO organization in North America who specialize in Cell and Gene Therapy. They have a state-of-the-art process development and cGMP manufacturing center equipped with two GMP suites for cell C> clinical production, and a C> process development pilot plant, to support the development and clinical manufacturing needs of their clients.

Position Overview

The Site Head will oversee the organization’s operations with a focus on enabling the growth and expansion of client-focused clinical manufacturing. This position will be responsible for several functions including: Manufacturing, Engineering, IT, Supply Chain, and Validation.

As the company continues to expand, the Site Head will be expected to contribute actively to executive decisions around overarching business strategy, including investment decisions and infrastructure and resourcing planning as they relate to implications for manufacturing and operations.

Responsibilities:

• Manages Technical Operations P&L ensuring the organization's objectives are met. Communicate the actualities of the P&L statement and ensure every employee is invested in positively influencing the financial situation of the organization.
• Prepare reports for and present to key stakeholders, including the Board or Directors and existing and potential investors.
• Deliver strategic leadership and vision to ensure successful scale up of client-specific manufacturing programs.
• Interact regularly with key customers and technology leaders to understand the existing and emerging needs of the markets.
• Ensure accountability for production and resource allocation.
• Provide strategic oversight for managing the growth and infrastructure needed to support the company's expansion by overseeing facilities, space planning and additional design / build as appropriate.
• Develop and report on balanced metrics which will provide focus for manufacturing performance.
• Promote scientific rigor and ensure industry-leading manufacturing operations.
• Establish a cohesive and integrated technical operations organization, including defining the structure, working standards and decision-making processes.
• Ensures adherence of organizational compliance with all regulatory, government, state, and local mandates/laws.
• Build operational talent, address key operational performance challenges, and implement best practices across reporting functions.
• Ensures Health, Safety, Environmental and Security standards are maintained in accordance with the organization's policies.
• Develop clear accountabilities and handoffs between the process development, MS&T and technical operations organizations.

Qualifications:

• CDMO industry experience would be highly desirable.
• BS in a scientific or related field with 10+ years progressive leadership experience in a biotechnology or pharmaceutical company
• Proven track record managing external contract manufacturing organizations
• Experience with global supply chains for biologics and/or advanced therapies
• Proven track record of leading cross functional teams in a rapidly growing and transforming environment.