Quality Control Scientist

Senior Associate Scientist QC Amsterdam | GMP | 8-10 Years Exp. | Analytical Assays | QC | Life Cycle Management |

Your new role We are seeking a highly motivated individual to join the Quality Control team in supporting our efforts in this exciting new area of cancer immunotherapy. In this role you will help provide Quality Control oversight of commercial manufacturing of final drug product. You will be working on introduction of new bioanalytical methods and related instruments for cell therapy products tests, life cycle management and troubleshooting of current QC analytical test methods and enhancing GMP data integration. You will provide scientific support for the QC analytical group, assisting in documentation revisions, addressing method issues, generating impact assessments, and leading root cause investigations.

Responsibilities (include but are not limited to): Collaborate with the Global network teams to discuss and coordinate new method/technology introductions and act as the liaison for our client Lead projects for the introduction and implementation of new methods and technology into the QC department Lead projects for Tech Transfer and implementation of product related to Analytical methods. Author and revise analytical methods qualification/validation protocols, specifications, reports, and other documentation. Lead and participate in the validation of analytical methods and automation within QC. Trouble shooting for Analytical assays and implement CAPA when necessary. Support the department by identifying issues that may affect laboratory or facility monitoring or work processes. Monitor the GMP systems currently in place to ensure compliance with documented policies. Write and or Implement changes to controlled documents. Review proposed changes to systems, procedures, methods and submissions to regulatory agencies, as appropriate. Lead in investigations regarding OOS results. Address and manage deviations related to analytical procedures. Monitor and Trend Analytical and stability data. Gather metric information for use in continuous improvement of areas of responsibilities. Interface with contract manufacturers to address QC analytical and related issues. Perform other duties as required.

What you’ll need to succeed Master’s degree in chemistry or biology with 8+ years industry experience in an analytical environment. PhD degree in Chemistry or Biology with 5+ years industry experience in an analytical environment. Expertise in analytical techniques such as Flow Cytometry, ELISAs, PCR, cell bioassays, and other biopharmaceutical testing methods. Working knowledge of cGMP and GLP. Project management skills are a plus. Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience. Proficient in Microsoft Office (Word, PowerPoint, Projects), with preferred excellence in Excel and JMP. Excellent verbal and written communication skills. Demonstrates effective time management skills and ability to work independently and as part of a team with internal and external clients, self-motivation, adaptability, and a positive attitude.

What you’ll get in return Hays Detachering | This is a project that will start with a contract for 12 months through Hays. Extension to stay within the department is anticipated. At this position, there is a gross annual salary of €76,000 and your travel expenses are covered. Visa sponsorship is not possible.

Your new company This company is dedicated to achieving one of the most ambitious goals of 21st century medicine: curing cancer. This mission is at the heart of everything they do, from early research to product development. They have been at the forefront of cancer immunotherapy and today are a leader in engineered T cell therapy, changing the paradigm of cancer treatment with what is potentially the biggest breakthrough since the introduction of combination chemotherapy more than 60 years ago. With an unrelenting drive and a singular focus on cell therapy, our team is executing on our strategy to bring life-saving therapies to patients.

With their brand-new production site in Hoofddorp and the R&D laboratories in Amsterdam, They are dreaming big. Now you can get the chance to be a part of this journey.

What you need to do now If you are interested in this role as

Senior Associate Scientist QC , click ‘Apply now’ to send an up-to-date CV, or give us a call! Is this job isn’t quite right for you, but are you still looking for a new position? Please contact us for a confidential discussion on your career.