Executive Director, Durham Tech Ops

Job Description

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

The Durham Technical Operations Leader is based in the Hilleman Vaccine Manufacturing facility in Durham, reports to the Vice President of global Vaccines Science and Technology, and is also a member of the Site Leadership Team, with a dotted line accountability to the Durham Plant Manager.  This individual will lead this multidisciplinary organization responsible for supporting the manufacture of critical, complex life-saving products through integrated support to site operations and quality teams.

The qualified candidate will guide the organization in providing direct support and expertise to routine commercial manufacturing as well as to in line technology transfers tied to facility expansions and upgrades. The Technical Operations Leader is accountable for ensuring that objectives are effectively achieved, consistent with Company requirements to ensure compliant, safe and reliable supply, equal employment, employee and environmental safety and health with harmonious employee relations and good relations in the local community. 

Primary Accountabilities:

• The Site Technical Operations Leader aligns with local and global automation, engineering, EHS, supply chain and operations leaders for maintenance of functional excellence and standard approaches.

• The organization is responsible for all aspects of technical process and product support including problem resolution, process improvements, technology transfers, process monitoring, process maintenance to API, Pharmaceutical, Vaccine, and Biologics manufacturing. This includes interaction with health authorities, both written communication and inspections.  The department structure includes dedicated support for each of 5 Integrated Process Teams (IPTs) in the operations areas, a centralized Validation organization, and a Process Support Laboratory with scale down model capabilities spanning a range of large molecule drug substance and drug product unit operations and characterization.

• Additionally, the Site Technical Operations Leader leverages the association with the global Large Molecule Technical Operations organization that provides external partner support, to collaborate on providing technical support to external partners within the region as a secondary responsibility.

• The Site Technical Operations Leader will typically lead a department of greater than 200 personnel and is responsible for ensuring the required competencies, talent management and development of people and is a member of the Site Leadership Team.

• They will create the environment in the group for collaboration across the interconnected, interdependent global network for the all the areas of responsibilities within scope, demonstrating a Boundary less Organization mindset (right people, place, time). This includes personal engagement, sponsorship of active participation in management of knowledge, communities of practice, virtual technical network, product stewardship, technology platforms and best practices sharing in the flow of the core work.

Education Requirement:

• Bachelor’s Degree in a related Science, Engineering or other Technical discipline.

Required Experience and Skills:

• A minimum of 10 years of experience in a comparable role and have experience contributing to the business at a directional, strategic level; ideal in a manufacturing, preferable Good Manufacturing Practice Setting.

• Biologics/Vaccines Operations management experience

• Equipment and process validation

• Understanding of mechanical/electrical/pneumatic processes

• Safety and Plant Policies and Procedures

• Knowledge of regulatory/code requirements to American and International Codes, Standards and Practices

• Recruitment and selection

• Employee Engagement/Relations

• Understanding of business and operations management models and their application

• Excellent communication, presentation and interpersonal skills, to interf