Job Description
The ( Pharmacokinetics, Dynamics, Metabolism, and Bioanalytics) PDMB Regulated Bioanalytics Department is seeking a sample management specialist to join our AdVVAnce Sample Management group located at our company's state-of-the-art AdVAnce research facility in West Point, PA. The AdVAnce bioanalytical team will be dedicated to advancing the fight against HPV and other serious illnesses and diseases by testing phase 3 clinical trial samples for our company's critical vaccines. The AdVAnce facility will not be fully constructed and ready for occupancy until 2026, and the work location for AdVAnce positions will vary until this time. Many roles will complete training and perform work at Springhouse Innovation Park facility in Lower Gwynedd Township, PA.
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The individual will be responsible to contribute with limited supervision to all aspects of development, implementation, operation, and troubleshooting of novel lab automation that will receive, aliquot, and store clinical and non-clinical study samples. The individual will also support efforts to interface automation tools with Laboratory Information Management Systems (LIMS) or other applications. The candidate should be current on state-of-the art technologies and is expected to champion evaluation of new technologies and optimize processes. Providing expert technical representation on multidisciplinary teams will be expected.
Education Minimum Requirement
- B.A./B.S. in Biology, Molecular Biology, Chemistry, Biochemistry, Engineering, Biotechnology, or related discipline with at least 3 years, M.S. with at least 3 years, or Ph.D. with hands-on experience in related field
Responsibilities
- Responsible for the development, implementation, operation, and troubleshooting of automation solutions (i.e. sample stores, liquid handlers, etc.) within the sample management laboratory that address the receipt, aliquoting, and storage of regulated clinical samples and reagents
- Support any manual sample management processes in order to maintain sample chain of custody of regulated study samples
- Evaluate new applications and systems enabling automated sample management
- 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)
- Use own scientific judgment to apply and adapt standard methods and techniques by applying prior work experience, consulting others appropriately
Required Experience & Skills
- Experience working within a laboratory, preferably working within a GxP-regulated lab
- Experience working with lab automation, such as liquid handlers, robotics, or automated sample stores
- Experience utilizing an inventory management system, such as a laboratory information management system (LIMS) or related system
- Capable of working independently
- Critical thinking and good trouble-shooting skills
- 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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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:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
12/21/2024
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Requisition ID:R326596