QC Chemistry Lead
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube
WHAT WE ARE LOOKING FOR
The QC Chemistry Lead operates in full compliance with applicable hygiene, safety, quality, and regulatory standards, and in alignment with the organization's framework, company's procedures, and the defined scope of responsibility the role is accountable for.
At the Guerbet Raleigh Imaging manufacturing facility, the Quality Control Lead is responsible for overseeing analytical testing and quality assurance processes within the chemistry lab. This role ensures compliance with cGMP (Current Good Manufacturing Practices), ICH guidelines, and regulatory standards while leading a team of chemists to maintain the integrity and accuracy of pharmaceutical products.
YOUR ROLE
- Lead, support, and mentor a team of QC chemists, ensuring adherence to laboratory protocols and regulatory requirements.
- Oversee the testing of raw materials, in-process samples, finished drug substances, and stability studies to ensure product quality.
- Implement and maintain quality control procedures to ensure compliance with FDA, EMA, and other regulatory agencies.
- Conduct investigations into out-of-specification (OOS) results and deviations (EXC), implementing corrective and preventive actions (CAPA).
- Ensure proper documentation and data integrity in accordance with Good Laboratory Practices (GLP).
- Collaborate with cross-functional teams, including quality assurance, manufacturing, and regulatory affairs, to support product development and release.
- Maintain and troubleshoot laboratory instruments such as HPLC, FTIR, UV-Vis Spectrophotometers, and other analytical equipment.
- Lead audits and inspections, ensuring readiness for regulatory reviews.
- Provide training and guidance to QC staff on analytical techniques and compliance standards.
- Ensure testing is performed in compliance with USP/EP/JP and internal specifications, SOPs, and cGMP standards.
- Participate in method transfers, validations, and verifications.
- Maintain lab readiness for regulatory inspections and internal audits.
- Train, mentor, and evaluate lab analysts; ensure proper documentation and lab safety practices.
- Support continuous improvement projects, including implementation of new equipment, methods, or automation tools
- Performs other duties as assigned by management
YOUR BACKGROUND
- Education: Bachelor's or Master's degree in Chemistry, Biochemistry, or a related scientific discipline.
- 5+ years of pharmaceutical QC laboratory experience with a strong background in analytical chemistry.
- 1-3 years in a leadership or senior analyst role preferred.
- Proficiency with HPLC, GC, UV-Vis, FTIR, titrations, wet chemistry.
- Familiarity with LIMS, CDS (e.g., Empower), and laboratory instrumentation qualification.
- Strong understanding of cGMP, FDA, ICH, and USP guidelines.
- Knowledge of industry regulations and best practices for data integrity.
- Effective communication and problem-solving skills.
- Thorough knowledge of cGMPs and pharmaceutical manufacturing requirements
- Demonstrated auditing and corrective action proficiency.
- Demonstrated record of successfully assessing and determining the impact of current and potential regulatory compliance issues.
Cognitive Requirements:
- Ability to read and understand military time.
- Experience in data quality control, auditing, or regulatory compliance.
- Strong analytical skills and attention to detail.
- Excellent leadership and team management abilities.
- Proficiency in data management tools and software.
- Excellent problem solving and decision-making skills.
- Ability to manage and drive change
- Ability to prioritize tasks and lead a team in a fast-paced, regulated environment.
- Computer skills
- Knowledge of document management/quality systems
- Ability to manage projects and processes with multiple functional groups without direct reporting authority
- Strong communication and interpersonal skills
- Getting work done through others that are not direct reports
- Operates with minimal direction, self-starter
- Building relationships with other departments
Reason to join US
Much more than a Competitive salary,
We offer continued personal development. When you join Guerbet, you :
- Are choosing a global leader with recognized expertise in diagnostic and interventional imaging,
- Are joining our 2820 collaborators who are committed every day to offering innovative solutions to improve quality of patient's life all over the world,
- Are joining a company where we value diversity of talents coming from various horizon.
We # Innovate # Cooperate # Care #Achieve at Guerbet.
Guerbet is an Equal Opportunity Employer. As an organization, we believe that no individual should be discriminated against because of their differences, which includes the following: age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All employment decisions shall be made without regard to age, race, creed, color, religion, sex, national origin, ancestry, disability status, veteran status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other basis as protected by federal, state, or local law. Guerbet is committed to diversity, equity, and inclusion.
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 or you can also call this number +19843443717