Executive Director, Technical Operations

Elkton Technical Operations Leader

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals 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 Elkton Technical Operations Leader is based in the manufacturing facility in Elkton, PA, reports to the Vice President, Vaccines Science and Technology and is also a member of the Elkton Site Leadership Team with dotted line accountability to the 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 investment in sustained process robustness and understanding through the associated process sciences laboratory capability.

Primary Responsibilities:

• Responsible for all aspects of technical process and product support including problem resolution, process improvements, technology transfers, process monitoring, and process maintenance. This includes interaction with health authorities, both written communication and inspections. The organizational structure includes dedicated support for each of 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.
• Lead a department of greater than 150 personnel and is responsible for ensuring the required competencies, talent management and development of people and is a member of the Site Leadership Team.
• 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.
• Align with local and global automation, engineering, EHS, supply chain and operations leaders for maintenance of functional excellence and standard approaches.

Education Requirements :

• Bachelor's degree in related Science, Engineering or other technical discipline.

Professional Requirements/ Competencies :

Experience and Technical Expertise :
Minimum of 10 years of experience in a comparable role and have experience contributing to the business at a directional, strategic level, with direct experience in manufacturing, preferable Good Manufacturing Practice Setting. Safety and Plant Policies and Procedures; knowledge of regulatory/code requirements to American and International Codes, Standards and Practices; strong understanding of business and operations management models and their application;

has extensive experience and expertise in vaccine development, commercialization and/or manufacturing with depth of knowledge in microbial fermentation and associated large scale operations; a demonstrated track record of applying scientific, technical knowledge and problem-solving approaches to deliver business results; in depth understanding of process engineering, equipment/process validation as well as in depth scientific process understanding.

Problem Solving/ Continuous Improvement Expertise :
Gathers and analyzes data and effectively responds to new, complex, or problematic situations; creates solutions that drive value for our company and our customers, incorporating innovative approaches. Models, coaches and teaches scientific problem-solving approaches with teams and peers. Demonstrates a lean mindset and drives continuous improvement. Demonstrated capability in establishing process stability in a challenging and complex scientific environment. Demonstrated capability in Lean Six Sigma, especially the definition and effective deployment of standard work.

Business Acumen and Financial Management: I n-depth knowledge of financial systems (budgets, expenses, product standards and variances); management of a large, agile organization with resources that include full-time and temporary employees providing a pipeline of talent at the site and global levels;…