Job DescriptionReporting to Microbiology Operations Lead, the Environmental Monitoring & Sterility Operations Lead will be a foundational hire responsible for building the Environmental Monitoring and Sterility Testing programs at our Wilmington site. Initially, this role will function as a hands-on technical expert and individual contributor, personally designing, developing, and executing the EM program infrastructure, sterility testing operations, qualification activities, and foundational documentation. As the site progresses toward full manufacturing operations, the EM Lead will transition into a people leadership role-recruiting, onboarding, and managing a growing team of QC Analysts while shifting focus from hands-on execution to program oversight, coaching, and continuous improvement. This is an ideal opportunity for a self-directed EM and sterility testing professional who thrives in building new programs independently and is ready to grow into team leadership as the organization scales.
Key Accountabilities:EM & Sterility Operations Design, Development & Oversight - In collaboration with site Quality, design and implement the site EM program including viable and non-viable monitoring strategies, risk-based sampling plans, alert/action limits, and trending frameworks.
- Establish the sterility testing program in accordance with compendial requirements (USP , EP 2.6.1), including membrane filtration, direct inoculation, and isolator-based operations.
- Author SOPs, sampling plans, method protocols, reports, and training curricula for both programs.
- Evaluate and implement rapid microbiological methods and automation to improve efficiency and reduce time-to-result.
Facility & Laboratory Start-Up - In collaboration with site Quality, lead the design and execution of Environmental Monitoring Performance Qualification (EMPQ) for classified areas.
- Commission and qualify sterility testing suites, isolator systems, and EM instrumentation.
- Support WFI & Utilities commissioning and qualification from a microbiological perspective.
- Conduct compendial method suitability and verification studies.
- Coordinate with Manufacturing, Facilities/Engineering, Quality, and Validation to ensure readiness prior to operational start-up.
Routine Operations & Compliance - Perform and provide oversight of routine EM sampling (air, surface, personnel monitoring) and sterility testing for batch release, stability, and validation samples.
- Oversee utilities monitoring for WFI, steam, and compressed gases.
- Ensure compliance with cGMP, biosafety, data integrity, and corporate policies across all activities.
- Maintain equipment qualification, calibration, and personnel training/gowning qualification programs.
- Lead investigations for EM excursions and sterility test failures, including root cause analysis, impact assessments, and CAPA implementation.
- Drive continuous improvement in program efficiency, data analytics, and trend visualization.
Leadership & Collaboration - As the site scales toward routine operations, recruit, onboard, and develop a team of EM and Sterility Analysts (~8-12 FTE at full capacity).
- Manage scheduling, performance, development, and succession planning.
- Mentor and coach team members to build a high-performing, inspection-ready culture.
- Represent the EM and sterility testing function in contamination control strategy discussions, site governance forums, and cross-functional meetings.
- Partner with Manufacturing, Engineering, Quality, and Regulatory to align activities with site priorities.
Qualifications / experience Education - Minimum: Bachelor's degree in Microbiology, Biotechnology, Biology, or related life science discipline.
- Preferred: Master's degree in a related discipline.
Experience - Minimum of 8 years of experience in pharmaceutical/biotech microbiology with progressive technical responsibility.
- Hands-on expertise in EM program design, execution, and management in classified manufacturing environments.
- Direct experience performing compendial sterility testing (USP , EP 2.6.1), including isolator operations and sterility test failure investigations.
- Proven experience with facility/laboratory start-up activities (EMPQ, equipment qualification, sterility suite commissioning, SOP development for new programs).
- Working knowledge of additional microbiological methods (bioburden, endotoxin, utilities surveillance).
- Experience with laboratory systems and equipment including:
- LIMS (Laboratory Information Management Systems) for sample management, scheduling, and results reporting
- Environmental monitoring data systems and trending software (i.e. MODA)
- Microbiology laboratory instrumentation (e.g., viable/non-viable air samplers, isolators, incubators, autoclaves, endotoxin detection systems, particle counters)
- Equipment qualification, calibration, preventive maintenance, and change control processes
- Computerized system validation (CSV) principles as applied to laboratory systems
- Familiarity with rapid microbiological methods, EM automation, and data analytics tools preferred.
- Prior supervisory experience preferred with demonstrated leadership within a QC operation
Core competencies and skills - Technical Expertise: Deep knowledge of pharmaceutical EM, sterility testing, contamination control, and aseptic manufacturing support
- Self-Direction: Ability to work autonomously and build programs with minimal oversight during start-up
- Leadership Potential: Readiness to grow into people management with evidence of mentoring or informal leadership
- Regulatory Knowledge: Strong understanding of USP , USP , EU Annex 1, FDA guidance, and PDA
- Problem Solving: Excellent investigation and root cause analysis skills, particularly for EM excursions and sterility test failures
- Adaptability: Comfort with evolving responsibilities, shifting from hands-on execution to strategic oversight as the site matures
- Collaboration: Ability to work effectively across Manufacturing, Engineering, Quality, and Regulatory functions
Additional Info: - Location (on-site): Wilmington, Delaware
- Physical Requirements: Ability to gown into classified environments and perform sampling/testing while wearing appropriate PPE, including respirators for high potent compound areas.
- Travel: ~10%
Required Skills: Analytical Thinking, Antibody Drug Conjugates (ADC), Biological Sciences, Biotechnology, Change Control Processes, Counterfeit Detection, Cross-Functional Teamwork, Environmental Monitoring, Immunoassays, Innovation, Laboratory Information Management System (LIMS), Microbiology, People Management, Quality Control (QC), Regulatory Compliance, Sample Management, Team Leadership
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.
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: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
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