Senior Specialist, Research Medical Device Combination Products - Onsite

Job Description

The Analytical Research and Development group has an opening for a Senior 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 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.   We are seeking a hands-on, lab-based specialist 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.

Primary 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.

Education Minimum 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.

Required Experience and Skills

• 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, are necessary to qualify for this role.

Preferred Experience and Skills

• Though not required, the ideal applicant would have 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 and experience leading cross-functional teams is a plus.

Required 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)

Preferred Skills:

Statistical Analysis

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