Analytical Validation- Supervisor (Quality) M/F (27781)

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We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, as well as digital and AI solutions for diagnostic and interventional imaging. As a pioneer in the field of contrast products for the last 95 years, we continuously innovate.

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WHAT WE'RE LOOKING FOR:

The Analytical Validation Supervisor works with and oversees members of the Lifecycle Management team on a variety of projects. This position is responsible for performing stability testing, qualifying and distributing reference standards, writing SOPs and methods as needed, performing method development and validation tasks, as well as coordinating all of these activities for the other members of the LCM group under the supervision of the QC Laboratory management.

YOUR ROLE:

Lead analytical project efforts, deliver project milestones on-time and on-quality, and represent analytical on cross-functional project core teams with representatives from Project Management, Chemistry, Engineering, Manufacturing, QC, and QA.
Qualify and evaluate analytical methods for the transfer to cGMP Quality Control laboratory for method validation.
Extensive hands-on experience and in-depth knowledge of 5 or more of the following analytical technologies including: chromatography (HPLC/GC/IC/UPLC/LC-MS/GC-MS), absorption spectroscopy, slope spectroscopy, FTIR, NMR, wet chemistry and/or USP, EP and JP methodologies.
Excellent time management, attention to detail and strong communication skills (both written and verbal) are required. The candidate should be able to efficiently communicate concepts to both specialist and general audiences. Customer-facing experience is vital.
Performs tests and assays via thorough understanding of laboratory standard operating procedures and instrumentation.
Writes and revises new and existing testing procedures, instrument procedures, and laboratory documentation procedures.
Performs experimental work under minimal supervision on future products and their respective testing procedures. Records and reports results and significant observations.
Performs specialized testing and performs independently method development, validations and transfers.
Ensure LCM group activities meet timelines provided by management.
Provide technical expertise and troubleshooting assistance to QC lab with regards to investigations and aberrant results.

YOUR PROFILE:

Will provide support to Quality by performing the development and implementation of more efficient methods.
Will provide support to Quality by answering technical questions and providing assistance with investigations and customer complaints, as needed.
Will assist with the qualification and distribution of CMDS reference standards.
Will assist with the creation of departmental SOPs and the revision of reference standard test methods.
Will assist with special projects assigned to the Lifecycle Management group, such as new product introduction and compliance with new compendial and regulatory guidelines.
Coordinate and supervise activities within the LCM group.

YOUR BACKGROUND:

Education required/preferred:

PhD in Analytical Chemistry or Chemistry with >7 year, masters in Analytical Chemistry or Chemistry with > 10 years, or a Bachelor’s degree with >15 years of industrial experience is preferred

Preferred Skills/Qualifications/Competencies:

Good interpersonal and verbal/written communication skills
Able to use a computer for data analysis
Able to lead a group effectively
Ability to oversee multiple projects and ensure timelines are met
Knowledge of laboratory safety, material safety
Working knowledge of cGMPs, GLPs, and FDA

EQUAL EMPLOYMENT OPPORTUNITY

Guerbet is committed to a policy of Equal Employment Opportunity and will not discriminate against an applicant or employee based on race, color, religion, creed, national origin or ancestry, sex, sexual orientation, gender identity or expression, age, physical or mental disability, veteran or military status, genetic information, or any other legally recognized protected basis under federal, state, or local law. The information collected by this application is solely to determine suitability for employment, verify identify, and maintain employment statistics on applicants.

Applicants with disabilities may be entitled to reasonable accommodation under the Americans with Disabilities Act and certain state or local laws. A reasonable accommodation is a change in the way things are normally done which will ensure an equal employment opportunity without imposing undue hardship on Guerbet. Please inform the company’s personnel representative if you need assistance completing this application or to otherwise participate in the application process.

Guerbet provides accommodations to applicants and employees with disabilities. If you need an accommodation to apply for a position please send an email to careers@guerbet.com.

WHY GUERBET?

4 weeks of PTO
Exempt-employee benefits start on start date, non-exempt benefits start a month after hire
Competitive 4% 401K match + 2% profit sharing contribution
Tuition reimbursement program for ongoing education