Specialist, Medical Device and Combination Product

MSD • Rahway, NJ

4d • Hybrid

About The Position

The Pharmaceutical Analytical Sciences team has an opening for a Specialist based in Rahway, NJ. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. In your role as Specialist, you will be part of a cross-functional team providing hands-on analytical testing support to enable medical device and combination product development and commercialization. We are seeking a hands-on, lab-based specialist to support characterization and GMP testing of devices (components, sub-assemblies, and full devices) and combination products (drug-delivery products) including method validation and transfer activities. The role will utilize a wide variety of cutting-edge analytical instruments in collaboration with device development teams, to build robust and consistent methods for clinical and commercial product release and stability testing.

Requirements

• Minimum 3+ years relevant industry experience for applicants with a Bachelor of Science or Engineering degree, or 1+ years of relevant industry experience for applicants with a Master of Science degree.
• Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.
• Candidates will also be required to work in a team environment with cross-functional interactions.
• Adaptability
• Analytical Chemistry
• Collaborative Development
• Cross-Functional Collaboration
• Data Analysis
• Device Development
• Experimentation
• GMP Compliance
• Incoming Inspection
• INCOMING RAW MATERIAL INSPECTION
• ISO Standard
• Lab Equipment Maintenance
• Medical Device Regulations
• Medical Devices
• Medical Devices Design
• Method Validation
• Package Testing
• Personal Initiative
• Regulatory Compliance
• Reviewing Literature
• Stakeholder Engagement
• Standard Operating Procedure (SOP)
• Strategic Planning
• Teamwork
• Technical Writing

Nice To Haves

• Hands-on experience in GMP operations, package component or medical device release testing, validation experience including engineering studies, design verification protocols, stability studies and validation protocols.
• Familiarity with ISO standards, FDA, and MDR regulations involving medical device requirements is a plus.

Responsibilities

• Responsible for executing method validation and performing test procedures for clinical supply release and stability testing according to specifications for medical device components and combination products.
• Responsible for performing validation activities to support commercial method validation and transfer activities in collaboration with Device Development & Technology, Development Quality, and Strategy Leads.
• Document the execution, procedure, results, and conclusions of experiments in a detailed manner in compliance with Standard Operating Procedures (SOPs) and Attributable, Legible, Contemporaneous, Original and Accurate (ALCOA) principles.
• Author technical reports, analysis certificates, investigations/deviation records, and SOPs.
• Work collaboratively with internal stakeholders and partners including Device Development, Development Quality and Materials Management.
• Troubleshoot and investigate any challenges associated with the GMP testing through active collaboration with cross-functional project teams and/or Quality stakeholders.
• Engage and participate in various internal and external current Good Manufacturing Practice (cGMP) audits.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level