Quality Control Group Leader - Cell Therapy

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

Job Description

Job Summary:

The Quality Control Group Leader will supervise a team of PSS employees as well as support the QC Analytical team in the following activities such as: assay performance, qualification/validation of assays and laboratory equipment, and transfer of methods. This position will be required to evaluate drug substance and drug products in order to meet the standards for identity, strength, quality, purity, and potency. This position will also play a vital role in performing assays to support stability study protocols, and training others.

Job Responsibilities:

• This position is responsible for performing the following laboratory procedures such as: cell culture, cell counts assay, determination of cell viability assays, proliferation and cytotoxicity assays, multi-color flow cytometry testing, mycoplasma, and endotoxin testing.
• Perform safety testing (Sterility, Mycoplasma, and Endotoxin) on drug substance and drug products for release.
• Supports the stability study protocols draft, revision, and testing for clients.
• Performs training of the other QC Analyst on current and new methods.
• Assists in completing the day-to-day functions and initiatives in the QC Laboratory.
• Logs in samples received into the QC Laboratory and provides support for shipping samples to other testing organizations.
• Analyzes and interprets data for analytical assays.
• Performing cell culture, media preparation, and preparations of solutions and reagents.
• Performs a cross functional role within the QC Department.
• Participate in technology transfer from the client under the supervision of the QC Supervisor.
• Participate in and supervise analytical method validation.
• Perform daily responsibilities and document work according to current procedures and GMP rules.
• Demonstrates technical proficiency in analytical methodology: Flow Cytometry, ELISA, Cell Counting, PCR-based assays and Cell Culture.
• Leads laboratory investigations, deviations, and resolves discrepancies with product testing.
• Interpret the obtained results and immediately alert the QC management in case of unusual event/result/out of specifications (OOS).
• Initiate deviation, OOS, change control (CHC) in connection with your work and perform necessary investigation.
• Implement curative and preventive actions (CAPA).
• Participate in audits when required.
• Support in-process and release testing and reviewing documentation to support COA.
• Responsible for material restocking, ordering, and performing checks on reagent expirations.
• Maintain open and effective communication with all other QC team members.
• Draft and Revision of Standard Operation Procedures, User Requirement Specifications, Sample Specification and Study Protocols.
• Actively lead weekly QC team meeting.
• Respect the safety rules within the laboratory.
• Participate in routine and planned maintenance, calibration, and qualification of equipment when required.
• Supervising other team members
• Performs other duties as assigned.

Qualifications

Basic Mini