Job Description

Job Description

Sample Management Specialist (P3), Regulated Bioanalytics, Integrated Logistics & Sample

Description

The PDMB Regulated Bioanalytics Department is seeking a Senior Sample Management Specialist to join our AdVAnce Sample Management group located at our Company's new state-of-the-art AdVAnce GxP 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. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. 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 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 1 years, or Ph.D. with hands-on experience in related field

Responsibilities

• Manage day-to-day sample management processes in order to maintain sample chain of custody of regulated clinical study samples

• Responsible for the operation, and initial troubleshooting of automation solutions (automated sample store, liquid handlers, etc.) within the sample management laboratory that address the receipt, aliquoting, and storage of regulated clinical samples and reagents

• 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, LIMS usage, 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

• Assist with writing and executing SDLC test cases, if necessary and as appropriate.

Experience & Skills

• Experience working within a laboratory, preferably working within a GxP-regulated lab, and proper documentation practices (eg ELN)

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

• Experience utilizing a laboratory inventory management system (LIMS) or related system for clinical sample tracking, task delegation, and reporting purposes

• Capable of working independently and overseeing operations

• 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

• Familiarity with Clinical Study design and test protocols and how to translate them into a LIMS system for sample tracking purposes.

• 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, management, team leaders, 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

#ProjectADVANCE

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:

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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

$104,200.00 - $163,900.00

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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (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:

No Travel Required

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Audits Compliance, Automation Solutions, Biochemistry, Cell-Based Assays, Clinical Testing, Communication, Critical Thinking, Delegation of Authority, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Inventory Management, Molecular Biology, Molecular Microbiology, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Project Prioritization, Proteomics, Regulatory Affairs Management {+ 5 more}

Preferred Skills:

Job Posting End Date:

10/1/2025

*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:R365698