Microbiology Operations Manager

Eurofins USA BioPharma Services; United States; On-site; USD 86,000 - 105,000; Full time

Benefits offered by this job

Medical, dental and vision options

401(k) with company match

Paid vacation and holidays

Life and disability insurance

Job summary

Eurofins USA BioPharma Services is seeking a microbiology laboratory leader to ensure testing compliance and daily operations. The role reports to the Site Director and works with Quality Manager, staff, and customers to maintain cGMP and ISO 17025 standards.

Responsibilities include supervising personnel, developing schedules, guiding test methods, and supporting regulatory documentation. Candidates should have a B.S.

Qualifications

• Bachelor’s degree in microbiology or related field.
• 2–3 years in a testing laboratory; supervisory experience preferred.
• Good knowledge of ISO 17025 and cGMP quality systems.

Responsibilities

• Provide operational leadership and manage personnel and resources.
• Support QA to ensure compliance with cGMP/ISO 17025 and company standards.
• Oversee scheduling, supervision, and training for analyses; manage reports delivery.
• Advise customers on regulatory guidelines, test results, and test method suitability.
• Develop new lab technologies and test methods; maintain equipment and QA systems.
• Hire and evaluate staff; communicate goals and give feedback.

Skills

Communication skills

Interpersonal skills

Problem solving

Microbiology knowledge

Education

Bachelor’s degree in microbiology

Job description

Job Description

Job Summary

Responsible for all activities in the microbiology laboratory, working closely with the Site Director, Microbiology staff, Quality Manager, Business Development and customers. Is a member of the Quality Committee and can act as a Business Unit Leader or Quality Manager in his/her absence. Ensures compliance of the testing within the microbiology laboratory with cGMP, ISO 17025 and company quality standards.

Essential Duties / Responsibilities

• Provides operational leadership and support through effective planning, execution, management of personnel and available resources.
• Motivates staff to perform at high levels, and ensures engaged employees, satisfied clients, and efficient processes that are quality driven.
• Assist the Business Unit Manager in managing daily operations of the microbiology laboratory including scheduling, supervising, instructing, monitoring, and assisting in the performance of manual and instrumental analyses. Develops and maintains production schedules, ensuring on-time completion and delivery of Reports and Data Packages into QA.
• Is a subject matter expert for the business in their field. Provides and assists customers with understanding regulatory guidelines, test results, technical support, and the appropriateness of specific tests, including advantages and limitations of test procedures.
• Accomplished productivity through effective communication of company goals/objectives and supports staff in achieving such expectations by appraising performance and giving continuous feedback.
• Plans and oversees development of new laboratory technologies and test methods.
• Ensures continuous development and training of staff.
• Ensures that the facility, instrumentation, and equipment are well maintained and in good working order.
• Ensures the implementation of the laboratory Quality Management System and its compliance with ISO/IEC 17025.
• Handles client and employee requests and concerns appropriate and in a timely manner.
• Performs laboratory testing, when necessary.
• Evaluates resumes, interviews potential employees, and hires new personnel.
• Assists in writing regulatory documents relating to the Quality Management System and regulatory agencies such as ISO, AAMI, USP, and FDA.

Qualifications

Education

• Bachelor’s degree in microbiology, or a related field.

Experience

• Minimum of 2-3 years of experience in a testing laboratory, with a preference given to candidates with supervisory experience
• Good knowledge of quality systems such as ISO 17025 and cGMP.
• Internal contact includes daily contact with all personnel and regular contact with management.
• External contact may require infrequent contact with Clients.
• External contact with vendors may be required.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.

Competencies

• Detailed understanding of microbiological sciences related to pharmaceutical and medical device testing.
• Excellent verbal and written communication skills.
• Excellent interpersonal and organizational skills.
• Responsive problem solver and action-oriented

Additional Information

Positions are full-time, working (Monday-Friday 8am-5pm), overtime as needed. Candidates currently living within commutable distance to North Brunswick Township, NJ are encouraged to apply.

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

• Comp: $95,000-105,000
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

Eurofins USA BioPharma Services is a Disabled and Veteran Equal Employment Opportunity employer.

Compensation

$95,000-$95,000 per year