Specialist - Stability & Sample Management

Job Overview

Position:
Sample Management Specialist

Department:
Pharmaceutical Analysis & Digital Technologies (PADT) – External Capabilities, Validation, and Compliance (ECVC), Research Laboratories Division

Location:

Rahway, New Jersey research facility

• Collaborate with internal and external partners in a cross‑functional environment to drive compliance and operational excellence.
• Receive analytical samples from partner groups according to established procedures.
• Aliquot, prepare, and label analytical samples for distribution to on‑site testing laboratories or shipment, including the coordination of international shipments.
• Manage analytical samples for large‑molecule pipeline stability studies.
• Maintain accurate records including sample inventory and sample chain of custody, leveraging digital systems such as LIMS, Benchling, electronic notebook, and eLogs.
• Build stability studies in LIMS and manage data.
• Perform deviations and investigations, create change‑management records where necessary, and manage GMP documentation including SOPs.

• Bachelor's degree or higher in analytical chemistry or a related field with 3+ years post‑degree relevant industry experience.

• Effective collaborator capable of working independently and within a cross‑functional team to deliver on complex objectives.
• Proven track record of strong technical and innovative problem‑solving.
• Desire and ability to learn new concepts outside core expertise and training.
• Excellent communication skills, creativity, and effective interpersonal skills.
• Experience working within a GMP environment and understanding of GMP policies and procedures.
• Related industry experience supporting management of analytical samples.

• Demonstrated commitment to diversity and inclusion.
• Experience leading a team toward a common goal.
• Experience in auditing and compliance within the pharmaceutical industry, including change management and deviation management.
• Experience supporting internal and external quality audits.

• Adaptability
• Analytical Chemistry
• Analytical Instrumentation
• Change Management
• Computer System Validation (CSV)
• Data Analysis
• Diversity and Inclusion
• Experimentation
• GMP Compliance
• GMP Environments
• Inventory Management
• Investigation Procedures
• Operational Excellence
• Personal Initiative
• Quality Auditing
• Regulatory Compliance
• Reviewing Literature
• Sample Management
• Scientific Research
• Standard Operating Procedure (SOP) Writing
• Teamwork
• Technical Writing

• Adaptability
• Analytical Chemistry
• Analytical Instrumentation
• Change Management
• Computer System Validation (CSV)
• Data Analysis
• Diversity and Inclusion
• Experimentation
• GMP Compliance
• GMP Environments
• Inventory Management
• Investigation Procedures
• Operational Excellence
• Personal Initiative
• Quality Auditing
• Regulatory Compliance
• Reviewing Literature
• Sample Management
• Scientific Research
• Standard Operating Procedure (SOP) Writing
• Teamwork
• Technical Writing

$96,200.00 – $

We offer a comprehensive package of benefits including medical, dental, vision, retirement (401(k)), paid holidays, vacation, and compassionate and sick days. Additional information is available on our benefits website.

10%

Day (1st shift)

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model consisting of three on‑site days per week (Monday–Thursday). Friday is designated as a remote day unless business‑critical tasks require on‑site presence.

As an Equal Employment Opportunity Employer, we provide equal opportunities for 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 legally protected characteristics. For more information about your rights, visit our EEOC resources.