Description
Job Overview
We are seeking an experienced Senior Specialist in Analytical Development to lead the creation and refinement of analytical methods. This role is critical to ensuring the successful development and production of high-quality medical products, collaborating closely with internal teams and external stakeholders.
Responsibilities

Design, develop, and improve analytical methods to support product development.
Provide expertise in resolving technical challenges and facilitating technology transfers.
Coordinate project plans to align analytical validation efforts with broader development timelines.
Oversee routine testing to support product development and ensure accurate results.
Lead risk assessments and ensure adherence to relevant regulatory standards.
Mentor and guide team members to foster a collaborative and productive environment.
Deliver clear and actionable recommendations to inform technical strategies and decisions.
Review and approve work completed by team members, including validation data and testing reports.
Maintain thorough and compliant documentation for all processes and results.

Qualifications

Bachelor’s degree in Chemistry, Analytical Science, or a closely related field.
Significant experience in developing and validating analytical methods.
In-depth knowledge of regulatory requirements such as ICH guidelines and GMP standards.
Proven experience in a leadership or supervisory role within a technical setting.
At least four years of experience in analytical development within the pharmaceutical or medical device industry.

Skills and Competencies

Strong problem-solving skills with a proactive approach to challenges.
Excellent written and verbal communication abilities.
A team player who can build positive working relationships and foster collaboration.
Demonstrates a strong commitment to quality and delivering exceptional results.
Organized and detail-oriented, with the ability to manage multiple tasks effectively.

Who You Are
You are a dedicated and innovative professional with a passion for analytical development. Your expertise and leadership skills enable you to manage complex projects and mentor your team to achieve exceptional results.
Where You Are From
Your academic background in chemistry or analytical sciences, combined with hands-on experience in regulated environments, provides you with the expertise to excel in this role. Your understanding of compliance and quality standards ensures success in delivering high-quality outcomes.
What We Can Offer

A key role in a forward-thinking and collaborative organization.
Opportunities to work on impactful projects in a cutting-edge field.
A supportive and growth-oriented work culture.
Competitive compensation and benefits package.

Diversity and Inclusion
Diversity and inclusion are essential to our mission and achieving our vision at CLS. The diversity we foster is one of our greatest strengths in delivering excellence through collaboration, respect, quality, and integrity without compromise. CLS is an Equal Opportunity Employer.