Overview
Scientist II, Quality Control Analytical Jobs in Portsmouth, USA at Lonza
Position
Scientist II, Quality Control Analytical
Location
101 International Drive, Portsmouth, NH 03801, United States
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 and business objectives.
- Identify potential challenges and risks associated with method transfer 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‑trend 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.
Qualifications
Requires a Bachelor’s degree, or foreign equivalent degree in Chemistry, Biochemistry, Biotechnology, or Molecular Biology and ten 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 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 filings; and participating in method transfers.
Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.
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Title: Scientist II, Quality Control Analytical
Company: Lonza
Location: Portsmouth, USA
Category:
