Merck · 6 hours ago
Site Microbiologist
Wilmington, DE
Full-time
Onsite
Director/Executive
$142K/yr - $224K/yr
15+ years expMerck is a global healthcare company committed to improving health and well-being. The Site Microbiologist role involves establishing contamination control strategies at the Wilmington Biotech Campus and ensuring compliance with regulatory requirements while supporting various teams in operations and quality assurance.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
Responsibilities
Acting in the role of Site Microbiologist
Responsible for ensuring that the processes for the manufacture of biologics have been conducted in compliance with GMP, the registered marketing authorization and the associated regulatory requirements
In-depth knowledge of US and European GMP guidelines, ICH and other international regulatory requirements, as applicable to the site
Drive compliance direction for the site by ensuring adherence to divisional policies and guidelines as well as regulatory requirements
Responsible for reviewing and approving GMP documentation to support corporate compliance/regulatory expectations for manufacturing operations
Assisting in, and facilitating investigations, ensuring effective Root Cause Analysis and CAPAs
Identify and facilitate major compliance initiatives to improve compliance status and overall operational efficiency of the site
Be an advocate of continuous improvement in the Quality Management Systems
Develop and provide oversite of the Environmental Monitoring program
Responsible for the management of the contamination control strategy as well as the contamination control plan
Drives opportunities for continuous improvement
Provide direct audit support and participate in response team for audits and inspections by Health Authorities
Provide support and expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations, and monitoring of follow up actions
Qualification
Required
Minimum of 15 years' experience in Quality Control, Quality Assurance or Pharmaceutical, Vaccine or Biological Operations, or Technical Operations
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends
At least 5 years of operational experience in a regulated environment
4 years' experience in Sterility Assurance or aseptic Drug Product manufacturing (liquid and lyophilized product) including clear understanding of aseptic processing requirements (including Annex I)
Demonstrated knowledge of Cleaning in Place, Sanitize in Place, and Aseptic Process Simulation
Demonstrated understanding of continuous quality / process improvement tools (As defined by the site, e.g. DMAIC, Lean QA, 5S etc)
Exceptional analytical, problem solving & root-cause analysis skills
Ability to multi-task and handle tasks with competing priorities effectively
Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & experience interfacing with regulators
Strong operations support background ensuring value added and effective quality oversight
A great communicator, decisive decision maker and proven ability to deliver excellence
Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends related to aseptic drug product manufacturing
Experience with new product introductions and/or process qualification/technology transfer
Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production & process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc
Excellent communication skills (written and oral)
Required to work on his/her own initiative in addition to working as part of and leading a team
Must be able to work across a team matrix to meet accelerated timelines
Desire to continuously learn, improve and develop
Ability to facilitate groups with diverse perspectives, and influence and bring teams to consensus and alignment
Effective communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner
Able to demonstrate good judgment in collecting and synthesizing relevant data and information to make independent and timely decisions; communicates influences and escalates issues and decisions as needed
Planning and scheduling skills, Proven organizational skills, Flexible approach
Goal/results orientated, Starter/Finisher
Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or in a relevant discipline
Preferred
Experience in manufacturing low bioburden Drug Substance
Previous experience in site microbiologist role
Capital Project experience
Direct experience in antibody drug conjugate manufacturing
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-01-24
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