Cell Therapy Associate

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

The Cell Therapy Associate is responsible for the manufacturing of cellular therapeutics for clinical applications within a GMP environment and reporting manufacturing data. This role requires skills to perform complex manufacturing operations with direct interaction with cellular product under minimal supervision.

Position Responsibilities:

• Manufacture cell therapy products per manufacturing batch records and in compliance with current regulations and quality standards. The duties required include basic cell culture and specialized cell culture techniques including, but not limited to, aseptic techniques for cell culture seeding, feeding and expansion, counting, harvesting, and cryopreservation
• Perform operations in a cleanroom environment, applying controls to assure aseptic processing including gowning, cleaning, and isolation procedures.
• Document each task involving manufacturing procedures, line clearance, maintenance and cleaning procedures per Good Documentation Practices (GDPs) upon completion.
• Accurately account for biobanking and dispensation of seed material and finished product.
• Demonstrate proficiency in current Good Manufacturing Practices (GMPs) and how they apply to specific tasks and responsibilities.
• Prepare documentation of non-conformance, deviations, and CAPAs.
• Train junior associates on technical and facility cleaning procedures, analyze manufacturing data for trending, perform review of executed records, work with others to assist in transfer of new procedures into manufacturing.
• Collaborate with Development to transfer new procedures into Manufacturing.
• May provide direction to junior staff and act as lead when necessary.
• Utilize and perform maintenance on equipment per standard operating procedures.
• Other duties as assigned

Qualifications

Basic Minimum Qualifications:

• Associate Degree with 6 years or Bachelor’s Degree with minimum 4 years’ GMP experience, preferably in cell therapy manufacturing.
• Ability to relate to others and communicate clearly. Fluency in spoken and written English. Technical writing skills for reporting data.
• Ability to apply basic laboratory mathematical concepts such as exponents, unit conversions, and scientific notation, calculate density and concentration of solutions, dilutions and titrations. Apply statistical analysis to manufacturing data.
• Standing and sitting for long periods of time may be required at times. Lifting, pushing, and pulling may be required for stocking and movement of equipment

Additional Information

Position is full-time and permanent, Monday-Friday, 8am-5pm with over time as needed. Candidates currently living in a commutable distance to Houston, TX are encouraged to apply.

What we offer:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
• Yearly goal-based bonus & eligibilit