Expert Scientist in Quality Control Microbiology

Alphanumeric Systems Canada Ltd; Rockville (MD); On-site; USD 125,000 - 150,000; Full time

Job summary

An established industry player is on the lookout for a QC Microbiologist to join their innovative team in Rockville, MD. This unique opportunity allows you to drive the implementation of cutting-edge microbiology technologies in the pharmaceutical sector, ensuring the highest quality standards for life-saving medications. With a focus on endotoxin detection and method development, your expertise will play a crucial role in advancing medical solutions. If you thrive in collaborative environments and are passionate about scientific innovation, this is the perfect chance to make a significant impact in the field of quality control microbiology.

Qualifications

• 3+ years in research or quality control functions required.
• Experience with method development and GMP operations essential.

Responsibilities

• Implement new microbiology technologies ensuring data integrity.
• Design and execute method development for endotoxin testing.
• Support validation and testing data for regulatory submissions.

Skills

Endotoxin detection methods

Method development

GMP laboratory operations

Analytical troubleshooting

Scientific report writing

Team collaboration

Communication skills

Education

BSc in Biological Sciences

Microbiology

Biochemistry

Job description

Alphanumeric is hiring a QC MICROBIOLOGIST to work out of Rockville, MD with our client of 20 years committed to improving lives through medical and pharmaceutical advancements.

We are seeking an Expert Scientist in Quality Control Microbiology with experience or specialty in endotoxin detection methods. This is an exciting and unique role where the applicant will have the opportunity to implement novel technology into biological and pharmaceutical products and processes.

DURATION: THROUGH 2024 (Most likely extended through the end of 2026)
100% ON SITE

HOURLY PAY: $42.50

Responsibilities

1. Drive implementation of new and rapid microbiology technologies that ensure data integrity, meet quality standards, and support regulatory submissions and delivery of quality medicines for patients.
2. Design and execute method development and GMP validation for recombinant factor C endotoxin testing.
3. Contribute to method development and method qualification.
4. Perform laboratory operations to support and implementation of compliant, state of art methodology and instrumentation.
5. Provide scientific understanding and analytical support for development of new test method, validation, and specifications.
6. Support for scientific report writing and document revision.
7. Provide analytical troubleshooting support for investigations which require non routine/specialized service.
8. Support microbiology technology validation and implementation for testing pharmaceutical products and manufacturing environment.
9. Provide validation and testing data for these new methods and technologies for internal advocacy and external regulatory submission.
10. Facilitate method transfer, validation, and implementation of new microbiology technologies at secondary commercial sites.
11. Work to GMP standards as appropriate.
12. Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Minimum Qualifications:

1. BSc in Biological Sciences or related area; Microbiology, Biochemistry or a related subject.
2. 3 years or more experience in working in research and/or analytical development and/or quality control functions.
3. Demonstrated experience and good working knowledge of method development, method validation/qualification.
4. Experience with GMP laboratory operations.
5. Strong team working skills, able to perform collaborative work across interdisciplinary groups.
6. Strong desire to learn/scientific curiosity, with cross functional learning agility.
7. Good organizational skills, ability to multitask and adapt to fast changing priorities and deadlines.
8. Excellent verbal and written communication (English).
9. Self-motivation.

Preferred Qualifications

1. An understanding of the theoretical and practical aspects of Pharmaceutical Microbiology (knowledge of rapid/alternative methodologies an advantage).
2. Demonstrated hands-on and/or practical experience in endotoxin detection methods of pharmaceutical products and/or water.
3. Capacity to think innovatively and flexibly for new microbiology methodology implementation, comfortable with complexity.
4. Experience in microbiology method and equipment development and/or validation.
5. Knowledge of biological and pharmaceutical product manufacturing and microbial control.
6. Experience with FDA regulations.