Technical Specialist - Chemistry

Smithers - Medical Device Testing · Akron, OH · 5 days ago

On-siteInformation TechnologyFull-time

About the role

Smithers is a global leader in delivering trusted analytical testing and consultancy services to a range of industries, including pharmaceuticals, medical devices, and packaging. We are seeking a highly skilled Technical Specialist to join our team in Akron.

Responsibilities

Act as a Subject Matter Expert (SME) in Extractables and Leachables (E&L) regulations, designing and delivering comprehensive analytical testing solutions tailored to client needs.
Develop and lead multi-staged E&L programs, providing expert advice on technical strategies and ensuring compliance with regulatory requirements.
Communicate effectively with clients through various channels (e.g., verbal, video conferencing, written, or in-person meetings) to provide high-quality consultancy and service.
Design and oversee analytical projects using techniques such as LC-MS/UV, GC-MS, FTIR, ICP, UV, conductivity, and pH.
Produce high-quality documentation, including test protocols, reports, and risk assessments, ensuring accuracy and compliance.
Support the development and delivery of technical presentations and workshops at conferences, which may involve international travel.
Stay at the forefront of scientific advancements in E&L, contributing to the growth and evolution of Smithers' services.
Collaborate with internal and external stakeholders to meet project deadlines, budgets, and quality standards.

Requirements

A degree in Chemistry, Analytical Science, or a related field (higher qualifications are advantageous).
Extensive experience in Extractables and Leachables testing and/or regulatory consultancy.
Proficiency in a wide range of analytical techniques, including LC-MS, GC-MS, and ICP.
Strong project management skills, with the ability to oversee complex, multi-stage technical programs.
Excellent communication and interpersonal skills, with the ability to build and maintain strong client relationships.
An attention to detail and a commitment to delivering high-quality work.
A proactive approach to continuous professional development in scientific advancements and industry regulations.

Qualifications

Desirable Skills And Experience:
Experience with cGMP, ISO 17025, or equivalent quality systems.
Familiarity with regulatory submissions and risk assessments.
Previous experience presenting at industry conferences or workshops.

Benefits

At Smithers, we provide an environment where technical excellence thrives. Our employees benefit from:

Competitive salary and benefits.
Paid time off and holiday pay.
Professional development and career progression opportunities.
A supportive and innovative work culture.

Pay

TBD

Schedule

TBD

Skills

Technical expertise in Extractables and Leachables (E&L) testing and regulatory consultancy.

Benefits

Competitive salary and benefits.

Paid time off and holiday pay.

Professional development and career progression opportunities.

A supportive and innovative work culture.

International travel opportunities for conference presentations.

Continuous professional development in scientific advancements and industry regulations.

Collaboration with internal and external stakeholders to meet project deadlines, budgets, and quality standards.