Merck & Co, Inc

QC Lab Ops & Operational Readiness Senior Specialist

Merck & Co, Inc • $106K — $167K *
Wilmington, DE 19805In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's degree in Chemistry, Biochemistry, Engineering, or related scientific discipline (advanced degree preferred)
  • Minimum 6 years of industry experience in QC testing within biotech or pharmaceuticals
  • Experience with laboratory start-up projects and formal project management (PMP preferred)
  • Strong quality background with experience in health authority inspections
  • Familiarity with cGMP environments and quality management systems
  • Knowledge of LIMS and digital laboratory tools like Veeva and Biovia
  • Experience in deviation/OOS investigations and CAPA processes.

Responsibilities

  • Build and maintain the QC laboratory operations readiness schedule
  • Identify dependencies and resourcing gaps; support weekly planning
  • Establish readiness stage-gates and define criteria with stakeholders
  • Coordinate drafting and approval of SOPs and related documents
  • Develop end-to-end sample management processes and workflows
  • Establish inventory control processes for laboratory supplies
  • Monitor operational KPIs and drive continuous improvement initiatives.

Benefits

  • Opportunity to work in a dynamic start-up environment
  • Engagement in cutting-edge QC laboratory operations for a new facility
  • Collaboration with cross-functional teams across different specializations
  • A role critical to achieving facility approval readiness and compliance maintenance
  • Potential for professional growth and development within a prominent biotech firm.
Full Job Description
Job Description

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.

Key Accountabilities:

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.


Additional Laboratory Operational Readiness Activities include;

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.


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.


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.


Qualifications / experience

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.


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.


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


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:

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

About Merck & Co, Inc

Schering-Plough Corporation is a major U.S.-based manufacturer of pharmaceuticals. It operates in three segments: Prescription Pharmaceuticals, Animal Health, and Consumer Health Care. Schering-Plough develops products targeting on allergy, cancer, hepatitis, cardiovascular, central nervous system, respiratory system, and more.  It was founded in 1851 by Ernst Christian Friedrich Schering as Schering AG in Germany. Schering-Plough manufactured several pharmaceutical drugs, the most well-known of which were the allergy drugs Claritin and Clarinex, an anti-cholesterol drug Vytorin, and a brain tumor drug Temodar. It also developed drugs targeting on central nervous system and the respiratory system. Schering Plough also owned and operated the major foot care brand name Dr. Scholl's and the skin care line Coppertone. These also became a part of the new company. Schering-Plough was a full member of the European Federation of Pharmaceutical Industries and Associations (EFPIA), a membership which is also maintained by the new Merck.

Merck & Co, Inc Careers

Join the visionary team at Merck & Co, Inc, a global leader in healthcare dedicated to advancing the world of medicine. As part of our professional community, you'll find dynamic job opportunities that foster innovation and leadership across various fields. Merck & Co, Inc is not just a company; it's a place where you can make a difference.

Work You’ll Do

At Merck & Co, Inc, we are committed to improving global health through groundbreaking research and innovative healthcare solutions. Our team is at the forefront of developing new therapies and vaccines that significantly impact public health worldwide. By joining us, you will collaborate with some of the brightest minds in the industry, using your skills to contribute to projects that save and improve lives around the globe.

Explore Career Paths

Whether you're seeking an internship, a graduate opportunity, or a professional position, Merck & Co, Inc offers a range of career paths in environments that promote rapid professional growth and development. Explore job opportunities in research, digital transformation, manufacturing, and more, all while benefiting from a culture that supports diversity and inclusion.

Innovate and Lead

Merck & Co, Inc is an ideal environment for those who lead with curiosity and the drive to innovate. Our leadership is committed to fostering a culture where inventive thinking and collaboration are encouraged, making it a perfect place for professionals who seek to make an impact through their work.

Develop Your Skills

With Merck & Co, Inc, you are not just getting a job; you're gaining access to unparalleled career development opportunities. Enhance your skills through diverse training programs, workshops, and continuous learning courses designed to help you grow at every stage of your career.

Benefits and Culture

We understand that our employees are our greatest asset, which is why we offer competitive benefits designed to support the health and well-being of you and your family. From comprehensive health care coverage and retirement plans to flexible working conditions and wellness programs, our benefits package is designed to meet the diverse needs of our team members.

Join Our Team

Ready to advance your career at Merck & Co, Inc? Search open positions that match your skills and interests. We are continuously hiring and looking for passionate, creative, and solution-driven team players. Prepare your resume, sharpen your interview skills, and become part of a company that's dedicated to making a difference.

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Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Engage with us through our careers blog and by participating in networking events and employment fairs. Subscribe to receive personalized job alerts and the latest news tailored to your preferences. Discover the exciting and rewarding opportunities that await at Merck & Co, Inc. Join us in our mission to improve health and wellness around the world.
Learn more about Merck & Co, Inc
Size
68,000 employees
Market Cap
$282.6 billion
Industry
Pharmaceuticals & Biotech
Net Income
$7 billion
Founded
1668
5 Year Trend
+4.1%
Revenue
$47.9 billion
NASDAQ
MRK
* Ladders Estimates

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