Senior Sample Management Specialist

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

Description

The PDMB Regulated Bioanalytics Department is seeking a Senior Sample Management Specialist to join our group which oversees sample management at our company's West Point, PA and Spring House, PA sites. We support bioanalytical testing for the development of small molecule, vaccines and biotherapeutics by facilitating efficient sample and critical reagent management while maintaining compliance with regulatory standards. We are seeking a highly talented and motivated individual with experience operating in a regulated laboratory to support sample management, including the receipt, distribution, shipment, and destruction of preclinical and clinical samples and reagents using a laboratory information management system (LIMS).

This individual will primarily support sample management within the small molecule and biotherapeutics area but cross-functional support in the vaccine space will also be required. As a senor level specialist, this individual will be expected to support all aspects sample and reagent management and maintain oversight of work being conducted within the PK/ADA space. The candidate is expected to champion evaluation of new technologies and implement automation tools to optimize processes. As a sample management subject matter expert (SME), representation on multidisciplinary teams will be expected.

Responsibilities

• Manage the chain of custody of regulated bioanalytical samples across a variety of potentially infectious matrices (blood, serum, etc.) and critical reagents from receipt through shipment/disposal
• Partner with staff to develop & drive process changes that innovate & improve the overall sample workflow.
• Collaborate with study personnel to coordinate sample and reagent shipments, resolve sample discrepancies, and handle logistics of international import/exports.
• Develop expertise in the use of Laboratory Information Management Systems (LIMS) to setup studies, maintain sample chain of custody records, and facilitate data reconciliation.
• Manage sample freezers, including the handling of temperature alarms and oversight of monitoring system/software.
• Represent the laboratory on all aspects of sample management during audit
• Train and/or coach junior staff on day-to-day sample management responsibilities
• Operate within the confines of departmental SOPs and regulatory guidances

Education Minimum Requirement :

• B.A. or B.S. Degree in Biology, Biochemistry, Analytical Chemistry, Chemistry or related sciences with at least 3 years of industry experience or an M.S. with 1-2 years of related experience.

Required Experience and Skills

• Experience working within a GLP or GMP laboratory
• Experience utilizing laboratory information management systems (LIMS) or databases
• Capable of working independently under moderate supervision
• Possesses good verbal and written communication skills and comfortable interacting with a variety of on-site and off-site collaborators
• Ability to work efficiently and to adapt to changes in assignments consistent with new or changing project priorities
• A knowledge of sample management and maintenance of sample chain of custody, with direct experience in this role required

#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:

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
$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 .

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:
No Travel Required

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
N/A

Required Skills:
Adaptability, Adaptability, Analytical Chemistry, Audits Compliance, Bioanalysis, Biochemistry, Biopharmaceuticals, Biopharmaceutics, Chemical Biology, Communication, Detail-Oriented, Documentations, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Immunochemistry, Laboratory Informatics, Laboratory Information Management System (LIMS), Microbiology, Organic Chemistry, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management {+ 4 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: R365702