Scientist II, Quality Control Analytical

Lonza•Portsmouth, NH

7d•Onsite

About The Position

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of. Lonza is seeking an experienced Scientist ll, Quality Control Analytical to join their team in Portsmouth, NH.

Requirements

Requires a Bachelor’s degree, or foreign equivalent degree in Chemistry, Biochemistry, Biotechnology, or Molecular Biology
10 years of progressive, post-baccalaureate experience in the job offered or 10 years of progressive, post-baccalaureate experience in a related occupation implementing equipment and test methods associated with the Spectrophotometry, Appearance testing and chromatographic methods
working in a cGMP laboratory
supporting projects and cross-functional teams within stated objectives and timelines
implementing regulatory requirements (e.g., US, EU, USP) and industry best practices and supporting regulatory fillings
participating in method transfers

Responsibilities

Manage, lead and execute analytical method transfer programs from initiation to completion, ensuring on time execution and adherence to program requirements and manufacturing readiness timelines.
Develop, implement and lead the transfer of analytical methods, including method verification, qualification and validation activities aligned with program requirements business objectives.
Identify potential challenges and risks associated with method transfers activities, developing mitigation strategies to ensure successful and on-time completion.
Participate in cross-functional teams as a Quality Control subject matter expert and technical resource responsible for providing quality control oversight and support to Validation and Tech Transfer manufacturing operations internally or at contracted suppliers.
Execute analytical testing as required to support on-time product release and in adherence with cGMP and the company’s procedures, policies and principles.
Review testing and laboratory records for accuracy and compliance with cGMP and the company’s procedures policies and principles.
Author, review, and/or approve SOPs, method transfer and validation plans, protocols, reports, specifications, and justification of specifications.
Oversee analytical and QC activities for site and Contract Testing Laboratories.
Identify, alert, and propose solutions to issues on instruments and test executions.
Perform data review and trend analysis to support all areas of laboratory operation.
Identify, facilitate, and/or lead continuous improvement efforts.
Perform and lead investigations for out of specification and out of trending data as per cGMP standards.
Support on-the-job training for junior QC personnel, review and escalate to management as needed.
Manage and Maintain an adequate inventory of supplies needed for all analytical testing requirements including but not limited to pipets, containers, and consumables.