Executive Director, Technical Operations

Merck•Elkton, VA

2d•$231,900 - $365,000•Hybrid

About The Position

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.

Requirements

Bachelor’s degree in related Science, Engineering or other technical discipline.
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.
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.
In-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; creates awareness of cost levers driving productivity at all levels.
Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team-oriented manner; communicates effectively with direct reports, extended organization, partners and stakeholders.
Sets clear performance standards including stretch goals for self and workgroup. Holds self and others accountable for achieving results; works proactively to remove barriers to achieving and exceeding goals; communicates a sense of urgency, high performance bars and changes to deliverables in a timely manner with workgroup and stakeholders; strong influence and decision-making skills.
Builds talent within teams/organizations with capabilities necessary for future success; continuously assesses competencies vs future needs, designing plans to fill gaps; actively coaches and develops team/ organization; demonstrated application of culture and business change methodologies (CEM, Inclusion and BCCM) when realizing site and cross functional process improvement initiatives; oversees and carries out Performance Management, Talent Management and Development activities.
Biopharmaceutical Operations
Change Agility
Chemical Engineering Fundamentals
Chemical Plant Operations
Consulting
Financial Acumen
Leadership Development Training
Manufacturing Scale-Up
Organizational Design
People Analytics
People Leadership
Project Controls Management
Strategic Thinking
Technical Communication

Nice To Haves

Current Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are place, introductions are position specific. Please, no phone calls or emails.
Employee Status: Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Hazardous Material(s):

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.