Quality Laboratory Systems Specialist

Merck • Wilmington, DE

1d • Onsite

About The Position

Join our company and shape the future of healthcare in Delaware.
At our Wilmington Biotech Campus, we are committed to keeping the patient at the very heart of all that we do and strive to find solutions and treatments for some of the world’s most challenging healthcare needs.
Our Company: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world — and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities.
With almost 70,000 employees operating in more than 120 countries, you will be joining one of the world’s largest pharmaceutical companies.
Wilmington Biotech Campus
The latest addition to the company's network is the Wilmington Biotech Campus. The site will play a pivotal role in the manufacture of our company's biologics-based medicines, including in the area of immuno-oncology. This site will establish our company's internal capability to manufacture high potent compounds when full manufacturing operations begin in 2029.
This facility will be a significant supplier of Antibody Drug Conjugates and High Potent Compounds and will also be critical in the future supply of new biotechnology products to its global network.
Wilmington Biotech Campus - Analytical Development and Quality Control Laboratory
The Analytical Development and Quality Control Laboratory at Wilmington Biotech Campus will be a transformational facility for the analytical commercialization of the company's pipeline
of high potent Biologics including our company's deep pipeline of Antibody Drug Conjugates. 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 in collaboration by our Research Laboratories and our Manufacturing.
Laboratory Systems Specialist:
Job Purpose:
Reporting to the Wilmington Laboratory Lead, the Laboratory System Specialist will support the development of the Laboratory Quality Management System (QMS) for the Wilmington laboratory.
This will involve the use of the company's Research Laboratories Clinical Supplies QMS and the our company's Manufacturing Division Commercial QMS to develop a local QMS in support of the scope of analytical work to be completed at the Wilmington laboratory.
Post laboratory start up the role will support ongoing maintenance and change control for the Wilmington laboratory QMS.

Requirements

• BS degree in science, biology, chemistry or some similar
• 2+ years of industry experience working directly in the field of analytical test, instrumentation and/or tech transfer.
• Preferably will have a strong Quality background.
• Experience with laboratory instrument Commission and Qualification, Data Integrity and Quality Systems.
• Experience with SOP creation and update.
• Good knowledge of global compliance requirements.
• Demonstrated examples of driving change in a positive way.

Responsibilities

• Support the development of a Laboratory QMS to bring together the research division's Clinical Supplies and the manufacturing division's Commercial QMSs into a single laboratory QMS;
• Identify the full scope of work of the laboratory
• Understand the regulatory compliance guidelines that will be applicable (ie FDA. EMA, PMDA etc)
• Work with site Quality and Global QMS Topic leads to define a strategy for QMS development for the Wilmington laboratory.
• Develop approaches to maximize the use of global SOPs at the Wilmington lab.
• When needed map key local processes to support local SOP development.
• Support development of SOPs for Analytical Instrumentation operations and administration.
• Support development of SOPs for Outsourced Testing and Services.
• Ensure appropriate technical, safety and quality review and approval of SOPs takes place prior to deployment.
• Ensure that appropriate change control and training programs are in place for the laboratory QMS.
• Post laboratory start up, support the ongoing maintenance and change control for the laboratory QMS.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level