What are the responsibilities and job description for the QC Microbiology Manager position at Eurofins?
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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
 In 2020, Eurofins generated total revenues of EUR € 5.4 billion, and has been among the best performing stocks in Europe over the past 20 years.
Job Description
The Manager, QC Microbiology, is a highly critical role and is responsible for managing Eurofins QC Microbiology Laboratory and Laboratory support group which provides critical support in a CAR-T manufacturing environment. The group is responsible microbiological related testing of in-process samples, final product testing, critical utilities sampling and testing, Validation and requalification support, incoming component testing, and microbiological identification. The Manager QC Microbiology is responsible for tracking group progress and essential processes as well as act as the SME during regulatory inspections.
Qualifications
Advanced knowledge of cGMP's, FDA, USP, MHRA, BP, EP, JP, PMDA, and DEA regulations and guidelines, as related to manufacture of cell therapy products.
· Advanced data integrity knowledge and practices.
· Intermediate understanding of statistics, control charts, action and alert limits.
· Advanced knowledge of Microbiology, media, incubation conditions, microorganism isolation, identification, and enumeration techniques, validations/suitability studies etc.
· Intermediate knowledge of Good Engineering Practices and Validation Principles: URS, IQ, OQ, PQ, PVs, etc.
· Ability to lead and maintain the development of Microbiology laboratory testing data and trending.
· Excellent verbal and written communication skills.
· Demonstrated critical reasoning, problem solving, troubleshooting, investigation, and decision- making skills.
· Must be team-oriented and has the demonstrated ability to work cross-departmentally throughout the manufacturing site.
· Demonstrated leadership and management skills, including establishing direction and goals, and guiding execution while fostering a team-based environment.
· Advanced mentoring and coaching, influencing, negotiating and personal interaction skills.
· Demonstrated resource management and planning skills. Must be flexible and adaptable, and able to work under pressure, while meeting designated timelines.
· Advanced knowledge of safety, OSHA, and EPA regulations. Electrical and energized equipment (lockout/tag out), fall safety, HAZCOM, MSDS sheets, etc.
· Advanced of Microsoft Word, Outlook, Excel, PowerPoint, etc.
Additional Information
Work schedule will be Monday-Friday 11pm-7am. Candidates currently living within a commutable distance of Summit, NJ are encouraged to apply.
What Happens Next
Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit you'll be invited to meet the team in the form of an assessment centre or a staged interview process dependent on the role and it's requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get you know your key skills and strengths.
Your data
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore we would urge candidates to submit an application as early as possible.
Due to the high volume of applications we receive please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date unfortunately, on this occasion your application has been unsuccessful.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
