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

Job Description

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.

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Wilmington Biotech Campus

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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.

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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.

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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.

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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.

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Principal Accountabilities:

• 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.

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Education Requirements:

• Bachelor's Degree

Skills and Knowledge

• 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.-
• Experience with a number of the following key levers:--
• 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.

Additional-Info: -

• Location;-US, Delaware, Wilmington (On site role).
• The successful individual will need to be available on site at the Wilmington Biotech site.

VETJOBS

Required Skills:
Analytical Testing, Analytical Testing, Aseptic Processing, Audit Management, Business Data Analytics, Business Due Diligence, Business Management, Calibration Management Software, cGMP Training, Customer-Focused, Detail-Oriented, Driving Continuous Improvement, Ethical Standards, Lab Equipment Maintenance, Laboratory Maintenance, Laboratory Techniques, Leadership, Manufacturing Compliance, Marketing Data Analytics, Personnel Recruitment, Project Execution Plan, Quality Control Documentation, Quality Management Systems (QMS), Quality Metrics, Quality Risk Management {+ 5 more}

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.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.--As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.- For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights

EEOC GINA Supplement•

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (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:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
02/4/2026
*A job posting is effective until 11:59:59PM on the day BEFORE -the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID: R381979