QC Lab Ops & Operational Readiness Senior Specialist

Job Description

At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and striving to find solutions and treatments for some of the world's most challenging healthcare needs.- -

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The Wilmington Biotech Campus will play a pivotal role in the manufacture of our company's biologics-based medicines, including the areas of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029. -

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This facility will be a significant supplier of Antibody Drug Conjugates (ADCs) and High Potent Compounds and will also be critical in the future supply of new biotechnology products to it's global network. -

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Wilmington Biotech Campus - Quality Control Laboratory -

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The QC Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of our company's pipeline of high potent Biologics. This laboratory will bring together late-stage analytical method development and validation with commercial release testing to deliver significantly improved speed through the analytical lifecycle. The laboratory will be supported by locally based advanced analytical subject matter experts and digital tools to enable an enterprise-wide connected laboratory in support of a new approach to analytical commercialization for high potent Biologics. The laboratory will be operated under our Manufacturing Division with close collaboration with our Research & Development Division. -

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Reporting to the QC Laboratory Operations Manager, the Laboratory Operations Senior Specialist - Operational Readiness is accountable for end-to-end QC laboratory operational readiness planning and execution in support of a new facility introduction. This role integrates laboratory operations workstreams, including equipment, system, and laboratory start-up readiness activities-into a single executable readiness plan aligned to the site Integrated Master Schedule. The role operates in parallel with construction, commissioning, and qualification activities to ensure the QC laboratory is ready to accept handover and achieve successful facility approval readiness through robust SOPs, training, supply readiness, and risk controls. Upon transition to steady-state operations, this role will own and drive ongoing laboratory operations activities.

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Key Accountabilities : -

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Integrated Laboratory Operational Readiness Planning & Schedule -

• Build, maintain, and govern the QC laboratory operations readiness schedule across workstreams aligned to the site Integrated Master Schedule and critical path. -
• Drive schedule convergence and acceleration: identify dependencies, sequencing conflicts, resourcing gaps, and pull-forward actions; support weekly lookahead planning and escalation for overdue/at-risk deliverables. -
• Establish laboratory operations readiness stage-gates and define entry/exit criteria with stakeholders to confirm readiness at critical milestones. -
• Partner with cross-functional stakeholders (Quality, Manufacturing, Supply Chain, Facilities/Engineering, our research division, and IT) to align laboratory operations readiness with site start-up timelines. -

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Additional Laboratory Operational Readiness Activities include; -

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SOPs & Document Readiness -

• Coordinate drafting, review, and approval of SOPs, Work Instructions, and Job Aids for laboratory operations activities -
• Maintain a document tracker integrated into the master readiness schedule. -

Sample Management -

• Develop the end-to-end sample management process (receipt, login, storage, tracking, distribution, retention/disposal). -
• Provide input on system master data and Implement sample workflows within LIMS; ensure chain of custody, traceability, and data integrity compliance. -

Laboratory Inventory Management -

• Develop inventory control processes for consumables, chemicals, reagents, reference standards, and supplies. -
• Coordinate supplier readiness, material master data, reorder points, and procurement workflows aligned to start-up sequencing. -

Stability Program Operations -

• Support stability operations including providing input on the design and oversee the start-up of the stability facility- and develop the process for sample pull scheduling, storage condition management, and sample distribution. -

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Quality & Compliance -

• Ensure all laboratory operations activities comply with cGMP, corporate quality policies, and regulatory requirements (FDA, EMA, ICH); maintain inspection readiness at all times. -
• Embed data integrity principles (ALCOA+) across all laboratory operations processes, records, and electronic systems. -
• Lead or support deviation investigations, OOS/OOT assessments, root cause analyses, and CAPAs related to laboratory operations as required -
• Manage change controls for laboratory operations processes, systems, and materials; assess impact and ensure proper implementation. -

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POST GO-LIVE: Steady-State Operations -

• Support the long-term daily requirements for laboratory operations-across sample management, solution/reagent preparation, inventory management, planning/scheduling, and stability activiies to ensure uninterrupted support of QC testing. -
• Monitor operational KPIs (e.g., sample turnaround time, solution availability, inventory stockout rate, schedule adherence); drive corrective actions for adverse trends. -
• Drive continuous improvement through standard work, lean practices, and automation opportunities; benchmark against network best practices. -
• Lead or support deviation investigations, OOS/OOT assessments, root cause analyses, and CAPAs related to laboratory operations. -
• Manage change controls for laboratory operations processes, systems, and materials; assess impact and ensure proper implementation. -

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Qualifications / experience -

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Education -

• Bachelor's degree in Chemistry, Biochemistry, Engineering, or a related scientific discipline (advanced degree preferred) -

Experience -

• Minimum 6 years of industry experience working directly in QC testing in a biotech / pharmaceutical or related discipline. -
• Proven experience with laboratory start-up projects, formal project management experience or PMP preferred.
• Strong quality background with direct experience supporting health authority inspections. -
• Experience in cGMP environments, QC lab operations, and quality management systems is required.
• Strong working knowledge of LIMS, inventory systems, and digital laboratory tools (e.g., Veeva, Kneat, Biovia). -
• Experience with deviation/OOS investigations, change control, and CAPA processes. -
• Knowledge of data integrity principles and their application to laboratory operations. -
• Demonstrated Lean/Six Sigma or continuous improvement experience.- -

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Core competencies and skills -

• Strong organizational skills; able to manage multiple priorities in a dynamic start-up environment. -
• Cross-functional collaboration and stakeholder integration. -
• Attention to detail with commitment to data integrity, compliance, and right-first-time execution. -
• Problem-solving, risk assessment, and clear escalation framing -
• Quality mindset - proactively identifies compliance gaps and drives resolution. -
• Drives change and continuous improvement in a positive way. -

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Additional Info: -

• Location: Wilmington Delaware (On-Site) -
• Travel: Ability to travel ~10% of the time -

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Required Skills:
Analytical Instrumentation, Analytical Method Development, Antibody Drug Conjugates (ADC), Data Integrity, Decision Making, Detail-Oriented, Good Manufacturing Practices (GMP), Laboratory Information Management System (LIMS), Laboratory Operations, Laboratory Safety, Lean Six Sigma (LSS), Project Management, Quality Standards, Regulatory Requirements, Risk Analysis, Risk Assessments, Root Cause Analysis (RCA), Sample Management, Scheduling, Stability Testing, Statistical Analysis, Strategic Collaborations, Team Problem Solving, Technical Transfer, Technical Writing

Preferred Skills:

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US and Puerto Rico Residents Only:

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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.

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The salary range for this role is
$106,200.00 - $167,200.00

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 .

You 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.

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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
Yes

Job Posting End Date:
07/28/2026
*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.

Requisition ID: R407173