Elkton GES Project Delivery Leader, Director

Elkton Ges Project Delivery Leader, Director

Our company's Global Engineering Solutions (GES) is seeking a highly motivated and experienced Project Delivery Leader to oversee the design, construction, installation, commissioning, and startup of a Drug Substance and Drug Product Facilities. This on-site Director role is based in Elkton, Virginia, and offers a unique opportunity to contribute to one of the most significant investments in Our company's human health manufacturing infrastructure in the United States. You will work alongside top-tier engineering, construction, and operational teams to deliver world-class capabilities. About the Project Our company is launching a major capital expansion at its Elkton, Virginia, site, a Center of Excellence for Pharmaceutical Manufacturing. This $3 billion investment will add approximately 400,000 square feet of state-of-the-art facilities, spanning both Active Pharmaceutical Ingredient (API) and Drug Product capabilities to support small molecule manufacturing and testing. This expansion advances our mission to deliver innovative treatment options for people facing serious health challenges in the U.S. and around the world.

Primary Responsibilities Include, But Are Not Limited To :

• Champion a strong safety culture.
• Ensure projects meet or exceed company EHS targets.
• Ensure compliance with company Standards, Procedures, and the company Quality Manual.
• Broad knowledge of the biopharmaceutical industry across multiple project types : drug substance, drug product, labs, large and small molecule, clean utilities, centralized utilities (steam, chilled water, electrical, etc.).
• Foster collaboration with Our company's Leadership, Site Stakeholders, Partners, and cross-functional teams.
• Apply Lean Project Delivery best practices and continuous improvement, update standard work.
• Effective communication and people skills to interface effectively with all levels of colleagues in a team environment.
• Provide leadership : Manage and coach team members; set clear business priorities and behavior expectations.

Candidate must live within or relocate to Elkton, VA vicinity. Initial assignment will involve less than 10% travel. Long term must have ability to travel up to 50% of time.

Safety Process safety : establish HAZID / HAZOP, and PSSRs to identify hazards early. Construction safety : implement safety plans, toolbox talks, audits, etc. to sustain a "target zero" culture. Site logistics : develop site logistics plans that prioritize safety and maximize productivity

Quality Establish and manage quality program. Design and construction quality assurance and control.

Core and Steering Lead the Capital Governance process to control scope and meet business goals. Run Tier / Safety / Staff meetings; manage stakeholder relations. Define optimal execution strategies considering complexity, geography, risk, and business impact.

Schedule planning Own integrated schedules from Business Case through first product manufacture and closeout. Drive resource planning and workload projection.

Develop site logistics and permitting strategies to keep schedule on track.

Procurement planning Coordinate sourcing and contracting strategies for design, construction, and critical vendors.

Risk Management Maintain a portfolio risk register and mitigation plans. Ensure quality control / assurance programs are in place and effective. Guide teams to simple, robust solutions while integrating compliance, permitting, and logistics risks.

Change Management Enforce governance rigor to control scope, cost, and schedule changes. Lead funding review processes; approve packages; align stakeholders.

TVD (Target Value Delivery) Apply Lean Project Delivery and Target Value Delivery principles to align scope, cost, and value to business outcomes. Coach teams in lean construction behaviors.

Front End Loading (FEL) nodes Support early FEL definition; lead final funding and Stage Gate reviews.

Planning / last planner Deploy Last Planner System for reliable workface planning. Improve look-ahead planning with partners.

Progress / productivity analysis, action recovery Use dashboards / KPIs for safety, quality, cost, schedule, and productivity progress. Conduct regular earned value, productivity and progress reviews; analyze variances and implement recovery plans. Track commissioning, qualification, and turnover readiness.

Education Minimum Requirement : Bachelor's degree in engineering Minimum of ten (10) years of Project Management experience in pharmaceutical or highly regulated manufacturing environments. Required Knowledge and Experience : Pharmaceutical manufacturing experience (drug substance, drug product, labs, large and small molecule, utilities) Deep understanding of cGMP and regulatory qualification requirements Commissioning and qualification experience Proven project management experience; PMP or equivalent preferred Portfolio / program management; ability to build and lead diverse, high-performing technical teams. Proven ability to navigate complex challenges, manage change, and drive project success under tight deadlines. Expertise in Lean Project Delivery (Target Value Delivery, Last Planner, Takt planning) Familiarity with modular / offsite construction Proficiency in scheduling, cost control, and project controls. Demonstrated use of BIM. Coaching and mentoring capability.

Required Skills : Accountability, Biopharmaceutical Industry, Biopharmaceuticals, Capital Management, Change Management, Chemical Process Development, Coach Team Members, Cost Management, Cross-Cultural Awareness, Cross-Functional Leadership, Decision Making, External Manufacturing, GMP Compliance, Innovation, Leadership, Lean Process Improvements, Manufacturing Scale-Up, Pharmaceutical Manufacturing, Planning, Planning Process, Portfolio Risk, Portfolio Risk Management, Process Improvements, Project Delivery {+ 7 more} Preferred Skills : U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The salary range for this role is $169,700.00 - $267,200.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https : / / jobs.merck.com / us / en / compensation-and-benefits .