Microbiologist - Group Leader (2nd Shift)

Rahway, NJ, USA

Full-time

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

In your role as Scientist, you will be a critical part of the Analytical Research and Development Microbiology team with responsibilities including leading the rapidly growing pipeline via collaboration with stakeholders to deliver on critical data in a good manufacturing practices (GMP) microbiology laboratory, including finished products testing, utilities, and environmental monitoring.

Primary Responsibilities

• Perform routine viable and non-viable Environmental Monitoring of classified cleanroom areas (Grad A-D), including surfaces, air, and equipment.

• Conduct active air, passive air (settle plates), surface sampling, in accordance with site EM programs and GMP requirements.

• Operate and maintain EM instruments (e.g., viable air samplers, particle counters, RODAC plates, isolator/BSC environmental sampling tools).

• Execute aseptic sampling techniques to ensure data integrity and contamination-free sample collection.

• Perform utility sampling/testing (WFI, purified water, clean steam) and support routine water system monitoring.

• Perform microbiology laboratory testing associated with EM samples, including bioburden, microbial identification, and endotoxin testing.

• Trend, analyze, and interpret EM data; escalate atypical or out-of-trend (OOT) results and support investigations.

• Participate in deviation investigations, root cause assessments, and CAPA development related to environmental or microbiological events.

• Maintain accurate documentation of sampling activities in compliance with ALCOA and data-integrity principles. Inventory management.

• Conduct microbiology finished goods testing and biological indicator (BIs) testing

• Support of sterile operations within the quality control department including utilizing isolator for sterility testing, conduct method suitability testing, endotoxin, microbial enumeration, media / reagent quality control testing, Experience with testing in clean room environments preferred

• Conduct the execution, procedure, results, and conclusions of experiments in a detailed and organized manner following ALCOA and data integrity principles

• Partner with internal stakeholders and partners, including Quality, Pipeline, and Operations.

• Perform second scientist review microbiology experiments in line with GMP expectations

• Support internal and external compliance audit activities.

• May need to be flexible with weekday work hours and weekend support as needed

Leadership Responsibilities:

• Support and monitors the performance of the team of employees

• May participate in new hire interviews

• Supports the on-boarding process of new employees

• Disseminate administrative communications

• Demonstrate and promote the company's vision

• Ensure adherence to highest quality and efficiency standards in laboratory operations

• Ensure coverage and performance for all shifts, and work duties

• Performs administrative tasks for team member growth and development

• Adeptly balance technical lab work with leadership responsibilities

• Foster morale and teamwork

Qualifications

Minimum Requirements:

• Minimum 2 years of pharmaceutical industry experience for applicants with a MS degree or 3 years of experiences for BS degree in Microbiology or related Biological Sciences, or equivalent with direct microbiological testing GMP experience

• A proven record of microbiology laboratory experience.

• Excellent written and oral communication skills, as well as interpersonal skills, are necessary to qualify for this role.

• Knowledge and experience of microbiology testing in context of, environmental monitoring, aseptic manufacturing, and utilities testing in a GMP environment

• Knowledge of current microbiology industry guidelines and compendia

• Previous experience in a leadership role

• Authorization to work in the United States indefinitely without restrictions

Preferred Experience

• • Knowledge in sterile, nonsterile and aseptic manufacturing and associated GMP product testing
• • Experience in supporting quality investigations in the microbiology discipline
• • Experience with MODA, SAP, Veeva, LIMS is a plus

Additional Information

Position is full-time, Mon-Fri 3pm-11pm Candidates currently living within a commutable distance of Rahway, NJ are encouraged to apply. Base compensation is between $29-36/hr based on experience. **2nd shift has a 10% shift differential. **

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holiday

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.