Job Description

The Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics (PDMB) Regulated Bioanalytics Department is seeking an Associate Director to lead our Regulated Bioanalytics Sample Management group located at our company's state-of-the-art AdVAnce research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

The individual will be responsible to lead all aspects of sample management operations, including deployment and troubleshooting of automated sample stores and liquid handlers, managing staff receiving and processing clinical study samples, and maintain highly compliant lab processes. The individual will also support efforts to implement and enhance Laboratory Information Management Systems (LIMS) or other applications used by the team. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes. Representing the lab during quality and regulatory audits will be required.

Education Minimum Requirement:

• B.A./B.S. in Biology, Molecular Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline with at least 7 years, M.S. with at least 5 years, or Ph.D. with 3 years experience in a related field

Responsibilities:

• Manage the development, implementation, operation, and troubleshooting of automation solutions (i.e. sample stores, liquid handlers, etc.) within the sample management laboratory that addresses the receipt, aliquoting, and storage of regulated clinical samples and reagents

• Lead staff through automated and manual sample receipt, processing, aliquoting, & distribution, ensuring efficiency and quality in sample management operations

• Evaluate and validate new or updated applications (e.g. LIMS, automation systems, etc.) that enable improved sample management processes

• Partner with IT on interfacing sample management automation data and systems into LIMS or other inventory management applications

• Serve as an internal subject matter expert on new and existing automated liquid handler and automated samples store technology and capabilities

• Train other sample management staff on sample management processes and the use of lab automation

• Author SOPs or job aids associated with sample management systems and processes

• Perform responsibilities in compliance with departmental SOPs and regulatory guidances (e.g., GxP)

• Serve as lab lead during internal or external regulatory audits

Required Experience & Skills:

• Experience leading sample management staff within a GxP regulated lab

• Experience working with lab automation, such as liquid handlers, robotics, or automated sample stores

• Experience implementing and validating new or updated lab applications such as a laboratory information management system (LIMS) or related system

• Strong verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators

• Ability to communicate effectively in presentations to stakeholders in partner organizations, to write technical reports, and to participate on cross-functional teams

• Ability to build and maintain strong relationships with site leaders, corporate management, and other stakeholders to ensure effective communication of plans and issues

• Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously

• Ability to prioritize projects and resources to deliver required level of output and support

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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".

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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

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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.

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Requisition ID:R326630