Associate Director, Analytical Development and Quality Control Laboratory- Instrument and Systems Lead jobs in United States
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Merck · 22 hours ago

Associate Director, Analytical Development and Quality Control Laboratory- Instrument and Systems Lead

Merck is a leading global biopharmaceutical company dedicated to improving health outcomes through innovative medicines and vaccines. The Associate Director will be responsible for establishing and managing laboratory instrumentation and systems at the Wilmington laboratory, ensuring compliance with quality standards and operational efficiency.

BiotechnologyHealth CareMedicalPharmaceutical
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Comp. & Benefits
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Responsibilities

Accountable for laboratory instrumentation purchase, instrument selection and the instrument quality systems
Support development of instrument commissioning, qualification and resource planning
Liaise with other company functions such as Quality and GES to ensure that commissioning and qualification execution plans can take place as scheduled
Support the development and approval of supporting documentation and ensure the highest standards of qualification execution
Lead interaction with the Qualification Services provider and external laboratory support groups to ensure execution plans are achieved
Develop and implement maintenance and calibration strategies to meet the needs of the business and comply with relevant industry and regulatory expectations
Ongoing responsibility for the management of laboratory instrumentation post laboratory start up ensuring that all instrumentation is maintained in a fully validated and calibrated state in support of analytical testing
Ensure that all laboratory and systems are inspection ready at all times
Support instrument personnel recruitment and training

Qualification

Analytical TestingLaboratory Instrument CommissioningQuality Management Systems (QMS)Data IntegrityLaboratory IT SystemsDriving Continuous ImprovementPersonnel RecruitmentLeadershipDetail-OrientedCustomer-Focused

Required

Bachelor's Degree
8 years of industry experience working directly in the field of analytical test, instrumentation and/or tech transfer
Preferably will have a strong Quality background with demonstrated, direct experience defending content during health authority inspections
Extensive experience with laboratory instrument Commission and Qualification, Data Integrity and Quality Systems
Experience with laboratory start up projects
Experience as a cross-functional leader with the ability to drive right first-time execution of projects
Demonstrated examples of driving change in a positive way
Experience with implementation and optimization of laboratory IT systems
Prior experience with Laboratory IT and connectivity to laboratory instrumentation
Accountable for laboratory instrumentation purchase, instrument selection and the instrument quality systems
Support development of instrument commissioning, qualification and resource planning
Liaise with other company functions such as Quality and GES to ensure that commissioning and qualification execution plans can take place as scheduled
Support the development and approval of supporting documentation and ensure the highest standards of qualification execution
Lead interaction with the Qualification Services provider and external laboratory support groups to ensure execution plans are achieved
Develop and implement maintenance and calibration strategies to meet the needs of the business and comply with relevant industry and regulatory expectations
Ongoing responsibility for the management of laboratory instrumentation post laboratory start up ensuring that all instrumentation is maintained in a fully validated and calibrated state in support of analytical testing
Ensure that all laboratory and systems are inspection ready at all times
Support instrument personnel recruitment and training

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 is a biopharmaceutical company that offers medicines and vaccines for various diseases.

Funding

Current Stage
Public Company
Total Funding
$5.59M
Key Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO

Leadership Team

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Betty Larson
Executive Vice President and Chief Human Resources Officer
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Dean Li
Executive Vice President and President, Merck Research Laboratories
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Company data provided by crunchbase