Share this Job

Guerbet is a leader in medical imaging worldwide, offering a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging, to improve the diagnosis and treatment of patients.

A pioneer since more than 90 years in the field of contrast media, Guerbet is continuously innovating with 9% of revenue dedicated to Research & Development and four centers in France, Israel and the United States.

Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €817 million in revenue in 2019 with a global workforce of over 2,800 employees.

Achieve, Cooperate, Care and Innovate are the values that Guerbet's employees share and practice every day. Working at Guerbet means playing a unique part in the future of medical imaging. Passionate about its business, the company strive day in, day out to combine performance, quality and sustainable development.

For more information about Guerbet, please go to www.guerbet.com  and follow Guerbet on Twitter @GuerbetGroup

 

Sr. Chemist/Quality Analyst

OUR NEED:

Sr. Chemist/Sr. Quality Analyst is responsible for evaluating material and product quality by performing data review, authoring investigations, and coordinating activities relating to Corrective/Preventative actions. This position interacts with formulation, filling, validation, engineering, and packaging personnel in support of those functions.  The qualified candidate will also work to guide the efforts of Chemistry lab personnel to assure test results, procedures, and methods are written, maintained, executed in conformance with current philosophies. Provide technical and troubleshooting assistance to junior lab personnel in regard to lab instrumentation and analysis of Chemistry data.  Work with other plant personnel to resolve problems related to actual or potential product quality problems. 

 

YOUR DUTIES:

  1. Assist Chemistry Lab Supervisor in guiding lab personnel to provide timely documentation and review of all chemistry testing, occasionally assisting as a working team member as necessary (requires knowledge of all chemistry Analysts’ jobs)
  2. Review and approve lab data for release, author lab investigations, coordinate CAPA activities (including documentation) related to the lab.
  3. Serve as laboratory liaison to validation group regarding new equipment selection, purchases, and validation
  4. Serve as expert in laboratory testing/requirements
  5. Perform troubleshooting guidance on laboratory testing such as HPLC testing, water testing wet chemistry, etc.
  6. Leads by example:  assists other Chemistry personnel in learning GDP, learning new tasks or new ways to perform old tasks.
  7. Analyzes trends chemistry data on a monthly basis to identify potential concerns with product quality and correct deviant situations
  8. Serve as contact point for chemistry as it relates to new product introduction, method validations, method transfers, and effective implementation thereof. 
  9. Assists in providing laboratory with an audit ready status as compared to global regulatory agencies as applicable.
  10. This person will take an active role in laboratory QA functions including, but not limited to:  OOS investigation, exception reporting/investigation, SOP writing/revising, external team participation, validation activities, new product introduction, records review, SOP/SM-R/specification management, and auditing.
  11. Performs experimental work under adequate supervision on future products and their respective testing procedures.
  12. Works in a team environment to support internal and external customer requirements.
  13. Will be responsible for maintaining inventory and reconciliation of laboratory supplies.
  14. Works independently with minimal supervision.

 

 

YOUR PROFILE:

  1. Performs duties of Chemistry Manager as needed upon designation.
  2. Coordinates testing of finished goods, stability, or raw materials and release thereof in a timely manner.
  3. Work safely in accordance with regulations, standards, and procedures and in a manner that eliminates unreasonable risk to health and the environment.  Notify management of unsafe conditions or practices, unlawful activities and activities which present unreasonable health and/or environmental risk.  Report all safety and/or environmental incidents to management immediately.
  4. Other duties as assigned with or without accommodation.

 

 

YOUR BACKGROUND:

 

Education required/ preferred:

Bachelor’s Degree preferably in Chemistry or equivalent

Experience:

Minimum ten years in Analytical Chemistry testing, in a pharmaceutical manufacturing environment, including

significant time initiating and resolving laboratory investigations,

as well as experience in handling corrective and preventative actions.

Preferred Skills/Qualifications:

Good interpersonal and verbal/written communication skills; able to use computer for data analysis

Previous leadership experience

Skills/Competencies:

Knowledge of laboratory safety, material safety; working knowledge of cGMPs, GLPs, and FDA requirements; knowledge of lab systems (Empower, LIMS, etc)