Operational Readiness Associate Director,

Job Description

Welcome to the Future of Precision Oncology – Join Us in Wilmington, DE!

We’re thrilled to announce the launch of our cutting-edge Antibody Drug Conjugate (ADC) manufacturing facility in Wilmington, Delaware—a bold step forward in transforming cancer care through innovation, collaboration, and purpose-driven science. This is more than a job - it’s a chance to be part of the next wave of cancer care. Whether you're an engineer, scientist, operator, or quality expert, your work here will contribute to life-changing therapies for patients around the world. Together, we’ll build a facility that not only meets the highest standards of safety and innovation but also fosters a culture of excellence, inclusion, and impact.

Join us in Wilmington and help shape the future of cancer treatment—one molecule at a time.

We invite you to become a part of our journey as the Operational Readiness Associate Director. This role offers you the chance to contribute to the site's development and ensure successful GMP manufacturing.

The Associate Director - Operational Readiness is accountable for end-to-end operational readiness planning and execution for a new site/facility introduction. The role integrates cross-functional workstreams into a single executable readiness plan, drives schedule acceleration opportunities, ensures governance discipline, and enables “operational excellence from day one”. The role operates in parallel with construction/commissioning activities to ensure the site is ready to accept handovers and achieve successful PPQ / facility approval readiness through robust SOPs, training, tech transfer alignment, incoming materials readiness, procurement execution, and risk controls.

Responsibilities

• Build, maintain, and govern the integrated operational readiness schedule across workstreams (SOPs, Tech Transfer, Incoming Materials, Procurement) aligned to the Integrated Master Schedule and critical path.
• Drive schedule convergence and acceleration: identify dependencies, sequencing conflicts, resourcing gaps, and pull-forward actions; run weekly lookahead planning and escalation for overdue/at-risk deliverables.
• Establish readiness stage-gates and define entry/exit criteria with stakeholders to confirm readiness at critical milestones.
• Coordinate prioritization, drafting, field shakedown, review, and approval of SOPs to enable shopfloor readiness.
• Ensure clear document strategy and ownership (e.g., what lives in SOP vs eBR vs local instructions) and maintain a document tracker integrated into the master schedule.
• Coordinate effectively across teams to guarantee proper resolution and communication of outstanding safety and risk-related tasks.
• Ensure operational readiness deliverables and timing remain aligned to Tech Transfer plans and QC method transfer planning.
• Integrate key Tech Transfer and QC readiness milestones into site reporting and governance.
• Oversee change control processes to ensure they are fully aligned with regulatory requirements, optimized for efficiency, and consistently executed according to established schedules.
• Drive operational excellence foundations: tier governance cadence, GEMBA/self-inspection routines, and readiness operating model embedded from the start.
• Enable stable execution through standard work, performance management, and continuous improvement rituals.
• Coordinate supplier transparency, material master data readiness, BOM redlines, and incoming materials strategy/list development.
• Ensure materials readiness is linked to eBR/MES needs, procurement lead times, and commissioning/start-up sequencing.
• Own the operational readiness risks & issues management: identification, assessment, mitigation planning, and escalation.
• Maintain and govern the operational readiness risk register; ensure mitigations have owners, due dates, and are integrated into the readiness schedule.
• Facilitate recurring risk reviews and ensure lessons learned feedback into schedule, training, and readiness deliverables.
• Build and maintain readiness dashboards (tier boards/scorecards) and schedule conformance; drive consistent weekly reporting.
• Define and implement KPI reporting discipline for monthly leadership updates; ensure data integrity and clear action linkage.
• Track readiness KPIs such as Right-First-Time execution, conformance to schedule, and critical path adherence; drive countermeasures through tier governance.
• Ensure operations is embedded with the project team and prepared for handover through early training exposure and readiness deliverables tied to system lifecycle activities.
• Promote a strong ownership and learning culture; leverage best practices and lessons learned from sister sites or prior launches where applicable.

Qualifications

Required

• Bachelor's of Science (BS) Degree in engineering, science or related discipline.
• Eight or more (8+) Years of experience in project, portfolio or program management.

Preferred

• Program/Project credential (PMP, PgMP, or equivalent)
• Demonstrated program/portfolio management experience (integrated schedules, dependencies, critical path, governance cadence).
• Experience leading cross-functional readiness, launch, or operationalization programs in regulated manufacturing environments.
• Strong risk/issue management discipline (risk registers, mitigation ownership, escalation).
• Executive-ready communication skills: concise dashboards, narrative updates, and decision framing.
• New facility introduction / expansion experience; operational readiness executed in parallel with construction/commissioning.
• Familiarity with tier-based management systems and shop floor cadence.
• Lean / Six Sigma experience
• Exposure to digital manufacturing foundations (e.g., MES/eBR readiness coordination).
• Proven experience leading large, cross-functional projects from initiation to successful delivery
• Ability to thrive in dynamic environments and adapt quickly to shifting priorities
• Skilled in influencing decisions on complex technical challenges
• Strong organizational and self-management skills; able to prioritize and adjust workload effectively
• Effective collaboration across diverse functions (e.g., Technical Services, Engineering, Quality, QC, IT, Operations) with ability to integrate workstreams
• Demonstrated ability to influence peers and business partners
• Strong interpersonal and team-building skills; foster effective collaboration among diverse styles
• Track record of delivering high-performance projects on time and within budget
• Proficient in continuous improvement methodologies (Lean, Six Sigma, etc.)
• Familiarity with documentation, deviation, and change management systems (e.g. Veeva, QualityDocs, Kneat)

Required Skills:

Adaptability, Adaptability, Antibody Drug Conjugates (ADC), Aseptic Processing, Cross-Cultural Awareness, Customer-Focused, Digital Manufacturing, Driving Continuous Improvement, Freeze Drying, GMP Compliance, Issue Management, KPI Reporting, Lean Six Sigma (LSS), Lean Six Sigma Process Improvement, Management Control Systems, Manufacturing Compliance, Manufacturing Quality Control, Operational Excellence, Pharmaceutical Microbiology, Process Improvements, Procurement, Project Management, Regulatory Compliance, Risk Management, Risk Registers {+ 1 more}

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

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

$129,000.00 - $203,100.00

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.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

No

Travel Requirements:

25%

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/19/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.