Elkton GES Project Delivery Leader, Director

Job Description

Elkton GES Project Delivery Leader Director

Our companys 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 companys 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 400000 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 companys Leadership Site Stakeholders Partners and crossfunctional 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 lookahead 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:

• Bachelors 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 highperforming 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:

Preferred Skills:

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Current Contingent Workers apply HERE

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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 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

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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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

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