Microbiologist

About the Role

The Quality Control Department at Serán BioScience in Bend, Oregon, is seeking a dedicated Microbiologist to support their Environmental Monitoring and Microbiology programs. This position primarily involves performing routine environmental and utility microbiological testing, including verification of cleaning processes in compliance with US-FDA, EU, and other industry regulations. Candidates with regulatory experience in pharmaceutical manufacturing or relevant microbiology and environmental monitoring backgrounds in related industries are highly encouraged to apply.

Key Responsibilities

• Perform routine environmental monitoring tests such as viable air and surface sampling, and non-viable particulate testing in aseptic and non-sterile areas.
• Conduct quality control analyses of utilities like high purity water systems (testing for Total Organic Carbon, Conductivity, Endotoxin, and Bioburden) and compressed gas systems (checking hydrocarbons, moisture, bioburden, particulates, etc.).
• Execute growth promotion and qualification testing supporting environmental monitoring strategies.
• Collect swab samples for cleaning process verification in manufacturing environments.
• Analyze and report environmental monitoring trends.
• Develop and implement microbiological testing protocols for manufacturing qualification.
• Prepare and manage documentation including Incident Reports, investigations, Change Controls, and CAPA processes.
• Serve as a subject matter expert (SME) for environmental monitoring and microbiology in cross-functional projects.
• Maintain laboratory orderliness, including cleaning, disinfecting surfaces and equipment, inventory management, and 5S initiatives.
• Coordinate sampling schedules with other departments and communicate results effectively.
• Log all samples and standards into the QC laboratory system.
• Follow Standard Operating Procedures, cGMP guidelines, and company policies.
• Identify and lead opportunities for process improvement within the department.
• Adjust work schedules as needed to meet testing demands and support company objectives.
• Perform additional related duties as required with potential for increased responsibilities aligned with company growth.

Candidate Requirements

• Excellent verbal and written communication abilities.
• Strong analytical thinking and problem-solving skills.
• Demonstrated capability to collaborate effectively within cross-functional teams.
• Exceptional organizational skills with acute attention to detail.
• Proficient time management and ability to meet deadlines.
• Skillful prioritization and delegation of tasks when appropriate.
• Ability to adapt and perform well in a fast-paced, dynamic work environment.
• Openness to constructive feedback and effective conflict management.
• Familiarity with Microsoft Office or similar software tools.

Education and Experience

• Bachelor's degree in a scientific field, preferably microbiology.
• Scientist I: Minimum 1 year experience in environmental monitoring or microbiological testing within a manufacturing setting.
• Scientist II: At least 2 years of GMP experience required; 3-5 years preferred in environmental or microbiological testing environments.

Physical Demands

• Ability to stand or sit for extended periods while monitoring equipment or working on data analysis and computers.
• Capability to regularly lift up to 25 pounds.
• Comfortable wearing Tyvek suits with PAPR for prolonged durations.
• Exposure to variable noise levels, including intermittent alarms.
• Work near heat-generating machinery.
• Physical agility to climb ladders, kneel, squat, and balance.
• Consistent, predictable onsite attendance is essential.

Additional Information

Serán BioScience prioritizes a collaborative, creative, and supportive workplace culture. Employees benefit from generous paid time off (over four weeks annually), low-cost health plans, basic life and long-term disability insurance, a 5% 401(k) contribution without employee match or vesting, and access to an Employee Assistance Program and pet insurance options.

The company's headquarters are located at 63047 Layton Ave, Bend, OR 97701. Applicants must be authorized to work in the United States as no visa sponsorship is provided. Artificial intelligence tools may support application evaluation, but hiring decisions are conducted by humans.