Job Description
Associate Director, Lab Systems
The Associate Director, Lab systems will work with the Digital Lead to help contract manufacturing organization (CMO) and contract labs (CL) establish the digital culture and mutually agreed to digital capabilities. This will include helping the CMO and CL select Lab systems, establish controls to assure real time data flow that meets business needs and expectations, facilitate technology transfer, and assure systems and metrics are in place to provide remote continuous oversight. The lead will work with global subject matter experts.
Primary Responsibilities:
Gain a deep understanding of the business processes, systems, and data that support Lab processes and programs related to our contract manufacturing and labs areas.
Build strong relationships and networks between Digital Manufacturing Divisio, business and External partners; share expertise and align to the enterprise digital strategy.
Thinks with a digital mindset and focus for the benefit of the business area.
Oversee and manage the master data management of various laboratory systems, including but not limited to LIMS, lab x, SoftMax pro, instruments integrations and other digital methods for record-keeping and analysis.
Oversight and support of change controls for laboratory systems, ensuring compliance with applicable procedures and generating detailed system requirements for initiating and progressing changes.
Execute technical changes based on requirements and technical assessment, collaborating with distributed teams to implement change requests in a timely, standard, compliant, and efficient manner.
Ensure data build compliance with global static data standards and drive master data standardization and process harmonization across the laboratory systems network.
Provide support for digital lab records, digital methods, and other laboratory systems, acting as a first-level diagnostic for incidents and supporting end users in the timely resolution of technical incidents through standard incident and problem management processes.
Draft and execute test protocols, coordinating with site/global teams in confirmation of requirements, design, and build.
Energetic self-starter with demonstrated ability to thrive in a dynamic and complex environment.
Demonstrates ability to articulate complex thoughts and ideas accurately and clearly, being able to quickly detect and correct instances of miscommunication. Demonstrates the ability to listen to others and integrate alternate points of view in decisions and ideas.
Preferred Experience/Qualifications:
Bachelor’s Degree or higher in relevant fields such as Computer Science, Biology, Microbiology, Pharmacy, Chemistry, or Engineering, or demonstration of equivalent experience.
A minimum of 10 years of hands-on experience in laboratory systems management, including LIMS (preferably Labware LIMS), lab x, digital methods, digital lab records, SoftMax pro and Instrument integrations in a pharmaceutical or related industry.
Proficiency in master data management in laboratory systems to support various testing, monitoring, and integration with external systems.
Extensive experience with digital lab records, digital methods, and overall laboratory systems, with a strong understanding of regulatory requirements for the manufacture and testing of pharmaceutical products.
Technical aptitude for computerized systems, analytics, and method evaluations, including hands-on working experience with SQL and stored query.
Experience of setting up or overseeing transformation of Laboratory Digital Systems will be a key strength for this role
Current Employees apply HERE
Current Contingent Workers apply HERE
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:
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Required Skills:
Preferred Skills:
Job Posting End Date:
*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.