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Senior Microbiologist

Reporting to the Manager, Microbiology, the Senior Microbiologist, will be responsible for performing biological assays of raw materials, in-process samples, finished product, and environmental monitoring samples. They will work with the microbiology personnel to assure test results, procedures, and methods are written, maintained, executed, and approved in accordance with approved SOPs and regulatory requirements.


ESSENTIAL DUTIES & RESPONSIBILITIES
  • Train and mentor analysts in troubleshooting issues related to documentation and testing
  • Support the development, verification, and validation of microbiological methods, including sterility, endotoxin, bioburden, AET, biological indicator enumeration and growth promotion testing
  • Review microbiological testing records for accuracy and adherence to test methods instrument malfunctions, and methodology problems
  • Act as a subject matter expert for microbiology and compliance, supporting deviation investigations, CAPA implementation, and technical audits
  • Lead and participate in continuous improvement projects in the laboratory including 5S and inventory management
  • Assist in the development and implementation of training programs that govern general and microbiological specific laboratory practices
  • Serve as a backup for sampling activities for environmental monitoring and facility utilities


QUALIFICATIONS, KNOWLEDGE, SKILLS, & ABILITIES
  • Bachelor’s degree (U.S. or foreign equivalent) in Biology or a related field.
  • Seven (7) years of pharmaceutical experience
  • Ability to work in a fast-paced environment with minimal supervision
  • Able to work flexible schedules at short notice
  • Work in a team environment with well-developed interpersonal skills and excellent organizational skills
  • Experience with EMPQs and Aseptic Process Simulations
  • Familiarity with QMS systems such as Master Control and BMRAM 
  • Working knowledge of cGMP, FDA, ICH, USP, and other regional and country specific guidance
  • Proficient in Microsoft Word, Excel, Outlook, and PowerPoint


PHYSICAL REQUIREMENTS
  • Prolonged periods sitting at a desk and working on a computer.
  • Must be able to lift up to 15 pounds at times.


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Average salary estimate

$90000 / YEARLY (est.)
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What You Should Know About Senior Microbiologist, August Bioservices

Join us at a leading pharmaceutical company in Nashville, Tennessee, as a Senior Microbiologist! In this role, you'll report to the Manager of Microbiology and take charge of performing and overseeing a variety of biological assays on raw materials, in-process samples, finished products, and environmental monitoring. Imagine being the key player who ensures that all test results and procedures align perfectly with our established SOPs and regulatory standards. Not only will you be training and mentoring analysts, but you'll also dive deep into the development, verification, and validation of microbiological methods. Your expertise in sterility testing, endotoxin analysis, bioburden assessment, and more will be critical as you review testing records for accuracy. You'll also serve as a subject matter expert, guiding investigations and audits while leading continuous improvement projects within our lab. If you thrive in a fast-paced environment and are looking for a place where you can actively contribute to innovative microbiological practices, this opportunity is perfect for you. Additionally, you'll help shape the future of our laboratory operations by assisting in training program development. If you're ready to bring your seven years of experience and your passion for teamwork to a dynamic organization, we want to hear from you!

Frequently Asked Questions (FAQs) for Senior Microbiologist Role at August Bioservices
What responsibilities does a Senior Microbiologist at this pharmaceutical company in Nashville undertake?

A Senior Microbiologist in our Nashville facility is primarily responsible for performing biological assays of various samples, ensuring that all procedures align with SOPs and regulatory requirements. They train and mentor new analysts, support the development and validation of microbiological testing methods, and review testing records for both accuracy and compliance with established methodologies.

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What qualifications are required for the Senior Microbiologist position in Nashville?

Candidates for the Senior Microbiologist position must hold a Bachelor's degree in Biology or a related field along with a minimum of seven years of pharmaceutical experience. Additionally, a deep understanding of cGMP, FDA regulations, and experience with QMS systems enhances a candidate's ability to succeed in this role.

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How does the Senior Microbiologist contribute to team leadership in Nashville?

In Nashville, the Senior Microbiologist takes on a leadership role by training and mentoring younger analysts and guiding them through troubleshooting processes. This role also involves leading continuous improvement projects within the laboratory and serving as a backup for various sampling activities, fostering a collaborative team environment.

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What skills are valued for the Senior Microbiologist position at this Nashville company?

Strong organizational skills, an ability to work independently in a fast-paced environment, and well-developed interpersonal skills are highly valued for the Senior Microbiologist role. Familiarity with EMPQs and Aseptic Process Simulations, alongside proficiency in Microsoft Office applications, is also crucial for success in this position.

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What is the work environment like for a Senior Microbiologist in Nashville?

The work environment for a Senior Microbiologist in Nashville is dynamic and fast-paced, requiring adaptability and a strong team spirit. The role combines desk work with hands-on laboratory activities, where analytical skills are applied in real-time to ensure compliance with rigorous testing standards.

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How can a Senior Microbiologist influence laboratory practices?

A Senior Microbiologist significantly influences laboratory practices by implementing training programs and continuous improvement projects like 5S and inventory management. This direct involvement ensures that all laboratory practices adhere to industry standards and enhance overall operational efficiency.

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Are there any physical requirements for the Senior Microbiologist role in Nashville?

Yes, the physical requirements for the Senior Microbiologist position include the ability to sit for prolonged periods at a desk, work on a computer, and occasionally lift objects up to 15 pounds. These requirements are important for managing daily tasks in a standard laboratory setting.

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Common Interview Questions for Senior Microbiologist
Can you explain your experience with biological assays and compliance with SOPs?

In an interview, describe specific instances where you performed biological assays, emphasizing how you ensured adherence to SOPs. Highlight the importance of compliance in your previous roles, and be prepared to discuss any challenges you faced and how you overcame them.

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How do you ensure accuracy in microbiological testing records?

To answer this question, outline the steps you take to verify that all documentation is accurate. Mention how you utilize checklists, peer reviews, and cross-referencing results to maintain high accuracy standards in microbiological testing records.

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Describe a time when you had to troubleshoot a microbiological testing issue?

When answering, narrate a specific situation where you identified a problem during microbiological testing. Discuss the troubleshooting steps you executed and how your interventions contributed to a successful resolution. Highlight what you learned from the experience.

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What methods have you developed or validated in microbiology?

Share details about any methodologies you’ve developed or validated. Discuss the process you followed, the challenges you faced, and how you ensured the methods met industry standards. Your answer should reflect your expertise and innovative approach.

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How do you stay current with microbiology standards and regulations?

In your response, outline the steps you take to stay informed about the latest microbiology standards. This may include attending workshops, participating in relevant webinars, or professional networking. Show your commitment to continuous learning and professional development.

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What role do you believe a Senior Microbiologist plays in a team environment?

Discuss the importance of a Senior Microbiologist in fostering collaboration and mentoring within the team. Highlight how you would balance leadership with teamwork, encouraging communication, and promoting a positive laboratory culture.

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How do you approach continuous improvement projects in the laboratory?

Share your strategy for initiating and managing continuous improvement projects. Discuss how you’ve approached past projects, including the goals you aimed to achieve and the outcomes of those initiatives. Emphasize your problem-solving skills and results-oriented mindset.

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Can you provide an example of working with a Quality Management System?

You should provide a specific example showcasing your experience working with a Quality Management System. Talk about how you utilized the system to maintain compliance, manage documentation or improve processes, and your role in training others on its use.

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What strategies do you use to manage your time effectively in a fast-paced environment?

In your answer, discuss techniques such as prioritizing tasks, using project management tools, and maintaining open communication with your team. Showcase your organizational skills and your ability to handle multiple priorities effectively.

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What are your strengths in microbiological practices, and how will they benefit our team?

Identify key strengths you possess, such as technical expertise, leadership capability, or attention to detail. Present examples that illustrate these strengths and how they can positively impact the team and enhance laboratory efficacy.

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Full-time, on-site
DATE POSTED
November 28, 2024

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