Senior Specialist, Research Medical Device Combination Products - Onsite

Merck•Rahway, NJ

1d•Onsite

About The Position

The Analytical Research and Development group has an opening for a Senior Specialist based in Rahway, NJ. The company fosters a culture 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 a global team, this role offers the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career. As a Senior Specialist, you will be part of a cross-functional team in charge of testing, managing, coordinating, and facilitating analytical support to enable medical device and combination product development and commercialization. This is a hands-on, lab-based specialist position to support 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

A PhD degree or 4 years of experience with a MS degree, or 7 years of experience with a BS in Science or Engineering.
A proven record of cross-functional collaboration, operational excellence, and strong technical problem solving.
Excellent written and oral communication skills, as well as interpersonal skills.
Accountability
Adaptability
Analytical Chemistry
Clinical Data Interpretation
Combination Products
Data Analysis
Documentation Review
Experimentation
GMP Compliance
Lab Equipment Maintenance
Laboratory Management
Method Validation
Personal Initiative
Project Reviews
Raw Material Testing
Regulatory Compliance
Scientific Research
Specification Documents
Strategic Planning
Teamwork
Technical Writing
U.S. Pharmacopeia (USP)

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.
Experience leading cross-functional teams.
Statistical Analysis

Responsibilities

Responsible for validating 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.
Support, manage, and coordinate analytical support for medical device release testing in a timely manner following GMP procedures.
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.
Perform data entry, data review/approval, and author analytical reports or data summaries.
Troubleshoot and lead any investigations associated with GMP testing through active collaboration with Device Development & Technology, Development Quality.
Identify appropriate corrective and preventative actions.
Directly contributes to experimental design, execution, and data interpretation for validation studies.
Support internal and external compliance audit activities.