Microbiologist

Microbiologist I

This position reports directly to the Quality Aseptic Manager. The role is responsible for overseeing third party sterility testing and environmental monitoring testing for the Company’s 503B sterile cGMP manufacturing facility. Responsible for environmental monitoring program including sampling, scheduling, and trending activities. This role offers a dynamic opportunity to drive environmental monitoring and Quality processes in a collaborative team setting.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

• Oversee environmental monitoring (EM) program, assist as needed
• Oversee EM process qualifications of new cleanroom areas
• Oversee microorganism identification program
• Understand Leiter’s monitoring programs and methods and conduct troubleshooting analysis
• Oversee or perform growth promotion testing of media as per compendial methods
• Assist in internal laboratory, as needed
• Work with internal and external resources to maintain lab in an optimal state
• Monitor, trend, and report environmental monitoring data, keeping management informed on trends and implementing corrective actions as necessary
• Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release. Assist in generation of CoAs for product release as needed
• Develop, revise, and review SOPs, job aids, forms, qualification/validation protocols, and reports
• Assist in investigations regarding out of specifications (OOS) results and deviations through root cause analysis
• Manage CAPAs and change controls to ensure timely resolution of issues and continuous improvement of Quality processes
• Monitor the GMP systems currently in place to ensure compliance with documented policies
• Review and assess proposed changes to procedures, systems, methods, and regulatory submissions as appropriate
• Gather and analyze metrics to drive continuous improvement in areas of responsibility
• Collaborate with Training, Quality Aseptic, and other departments for implementing process improvements and job aids
• Collaborate with Quality Control department to ensure timely completion of environmental monitoring testing and sterility testing as needed for batch release
• Perform other duties as required

Experience and Necessary Skills:

• Bachelor’s degree in Microbiology, Biology, or related technological field of science required
• 1-3 years of microbiology lab experience and/or environmental monitoring in the biotech and/or pharmaceutical industry working with sterile injectables required
• Proficient in microbiological techniques, including air monitoring, water testing, surface monitoring, and microbial identification
• Experience with aseptic technique and cleanroom operation
• Experience with the sterile gowning procedures
• Knowledge of regulatory requirements for aseptic operations and manufacturing of sterile drug products
• Working knowledge of quality systems and regulatory requirements (21 CFR Part 11/210/211)
• Strong knowledge of GMP, SOPs, and quality control processes
• Experience managing and resolving OOS results and investigations
• Working knowledge of aseptic manufacturing and EM processes
• Proficient in MS Word, Excel, Power Point and other applications
• Ability to communicate and work independently with scientific/technical personnel
• Strong critical thinking, troubleshooting, and problem-solving abilities
• Self-motivated and willing to accept temporary responsibilities outside of initial job description
• Excellent interpersonal, verbal, and written communication skills in a collaborative work environment
• Comfortable in a fast-paced, small company environment with minimal oversight and able to adjust workload based upon changing priorities.

Benefits:

• Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
• Flexible Spending & Health Savings Accounts (FSA & HSA) available
• Dental & Vision insurance
• Employer Paid Life Insurance & Employee Assistance Program
• Short Term & Long-Term Disability Insurance
• Up to 4% 401K Matching (100% vested on day one!)
• Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
• $5,250 Annual Tuition Reimbursement after 6 months
• $1,000 Referral Bonus Program with no limit
• Eligible for annual bonus program

Timeline: We will be accepting applications on an ongoing basis until position is filled.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law .

*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.