Microbiologist 3

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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.

The MilliporeSigma Carlsbad Viral Vector Manufacturing facilities are a Contract Development and Manufacturing Organization (CDMO) dedicated to the manufacture of clinical and commercial viral vector therapies. The site offers comprehensive services from process development, cell and viral banking, tech transfer, fill finish, and viral vector testing and manufacturing. This is a fast-paced, constantly evolving environment that aims to meet client needs while being held to strict regulatory standards for therapeutic biologics.

Your role:

As a Microbiologist 3 in the Microbiology group, you will support the site through testing the quality of the cleanroom manufacturing environment as well as performing microbiological assays in the Quality Control laboratory. This will ensure that products produced at the Carlsbad Viral Vector Manufacturing (CLD-VVM) plant adhere to strict regulatory and ISO requirements. Your delivery of on-time and quality results will support MilliporeSigma’s place as an industry leader in viral vector manufacturing. Microbiologist 3’s take a leading role in the team by authoring and leading studies, including method validation and sample-specific studies, performance qualifications, and Corrective and Preventative Action (CAPA) projects. Microbiologist 3’s support laboratory operations, testing incoming raw materials as well as in-process samples. Microbiologist 3’s also support cleanroom operations, collecting surface, air, utility (process gas and water), and personnel samples, as well as supporting monitoring of manufacturing fill/finish process.

Comply with company EH&S requirements, promote a safety-first culture, and support safe laboratory operations.

Perform environmental monitoring of cleanrooms and utilities, including process gases and water systems.

Conduct microbiological testing of raw materials, pharmaceutical water, and other samples in accordance with SOPs.

Operate, maintain, clean, and sterilize laboratory equipment, including autoclaves; manage supplies and consumable inventory.

Compile trend data and author reports, studies, and protocols, including bioburden validation, endotoxin inhibition/enhancement, hold-time, and disinfectant efficacy studies.

Implement new test methods and equipment and lead protocol execution for special studies and projects.

Lead change controls and CAPAs; report and investigate deviations, nonconformances, and related quality events.

Maintain accurate, timely, and data-integrity-compliant documentation, including raw data, testing records, logbooks, and SOP revisions, in accordance with ALCOA+ principles; support off-shift, weekend, and overtime operations as needed.

Physical Attributes:

Wearing PPE when entering the cleanroom space. PPE includes, safety glasses, face masks, hoods, scrubs, sterile gowns, gloves, sleeves, and boot covers.

Sitting and reaching to use computers and other office/lab equipment.

Occasionally standing for extended periods of time, up to four (4) to five (5) hours/time.

Occasionally lifting up to fifty (50) pounds.

Viewing objects at close and distant ranges. Occasional exposure to fumes, airborne particles, chemicals, vibration and biohazardous materials.

Who you are:

Minimum Qualifications:

Bachelor’s Degree in Biology, Microbiology, Chemistry or other Life Science Discipline

4+ years of quality analysis experience

OR

High School Diploma or GED

6+ years of quality analysis experience

Preferred Qualifications:

Experience with cGMP, aseptic techniques, microbiology testing, automation, troubleshooting for equipment, software and data integrity

Understanding and knowledge of governmental regulatory guidelines relating to the manufacturing of biologics and pharmaceuticals

Experience with Aseptic Technique and Cleanroom Gowning

Coursework in Microbiology

Experience working in a Quality Control laboratory

Pay Range for this position: $26-$40 per hour.

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here .

RSREMD

What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!

Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!