Microbiologist

Leiters Inc•Englewood, CO

10d•$55,000 - $69,000

About The Position

The Microbiologist I reports directly to the Quality Aseptic Manager and oversees third-party sterility testing and environmental monitoring testing for the Company’s 503B sterile cGMP manufacturing facility. The role is responsible for the environmental monitoring program, including sampling, scheduling, trending, and reporting, and supports the facility’s quality processes in a collaborative team setting. The position also oversees environmental monitoring process qualifications for new cleanroom areas and the microorganism identification program. It supports laboratory activities, quality-system documentation, investigations, CAPAs, change controls, and continuous improvement while helping ensure compliance with GMP policies and applicable regulatory requirements.

Requirements

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

Responsibilities

Oversee the environmental monitoring program and assist with its activities as needed.
Oversee environmental monitoring process qualifications for new cleanroom areas.
Oversee the microorganism identification program.
Understand the company’s monitoring programs and methods and conduct troubleshooting analysis.
Oversee or perform growth promotion testing of media according to compendial methods.
Assist in the internal laboratory as needed.
Work with internal and external resources to maintain the laboratory in an optimal state.
Monitor, trend, and report environmental monitoring data; keep management informed of trends and implement corrective actions as necessary.
Complete routine review of test data and related documents for in-process testing and drug substance and drug product release; assist with generating Certificates of Analysis for product release as needed.
Develop, revise, and review SOPs, job aids, forms, qualification and validation protocols, and reports.
Assist with investigations of out-of-specification results and deviations through root cause analysis.
Manage CAPAs and change controls to support timely issue resolution and continuous improvement of Quality processes.
Monitor existing GMP systems 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 to implement process improvements and job aids.
Collaborate with Quality Control to ensure timely completion of environmental monitoring and sterility testing as needed for batch release.
Perform other duties as required.

Benefits

Healthcare coverage options that reward wellness.
Flexible Spending Accounts and Health Savings Accounts.
Dental and vision insurance.
Employer-paid life insurance.
Employee Assistance Program.
Short-term and long-term disability insurance.
401(k) matching of up to 4%, 100% vested on day one.
Paid time off options, including vacation, sick leave, paid leave, and holidays.
Annual tuition reimbursement of up to $5,250 after six months.
Referral bonus program of $1,000 with no limit.
Eligibility for an annual bonus program.