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

MSD

1d • Onsite

About The Position

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. At our company, we are unified around our purpose: 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 our company 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 our 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 company's Research Laboratories and our company's Manufacturing. Instrument and Systems Lead Job Purpose: Reporting to the Wilmington Laboratory Lead, the Instrument and Systems Lead is accountable for establishing the laboratory instrumentation and laboratory systems needed for the Wilmington laboratory. This will involve leading the purchase of instrumentation, qualification activities, creation of maintenance/calibration programs and the development of the instrument management quality system. Post laboratory start up the role will be accountable for ongoing support to laboratory instrumentation and systems.

Requirements

• Bachelor's Degree
• 8 years of industry experience working directly in the field of analytical test, instrumentation and/or tech transfer.
• 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.

Nice To Haves

• Preferably will have a strong Quality background with demonstrated, direct experience defending content during health authority inspections.

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.

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: Director
• Number of Employees: 5,001-10,000 employees