Careers

Mesa Biotech strives to deliver the next generation of reliable molecular diagnostic tests. The key to our success is our team of dedicated and talented employees, employees that are driven to deliver novel, quality diagnostic products. Explore the careers available at Mesa Biotech below:

Available Positions

Equipment Operator Technician

Location: San Diego, CA Mesa Biotech is a fast growing, ISO certified, FDA approved, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician’s office to the patient’s home. We are seeking a motivated Equipment Operator Technician who will support Manufacturing and Operations staff primarily in the Mesa Biotech lateral flow strip and lyophilization bead manufacturing process. This position will build and test small and large lots using equipment focused on dispensing and/or striping solutions using striping and dispensing equipment. This position will also work closely with the Chemistry Formulations Specialist and Manufacturing Engineers in the lyophilization process and overall process improvement and R&D for new product transfer.

We are looking for someone with:

* A minimum of 2-3 years’ experience using standard laboratory equipment, especially filling, fluid dispensing and striping.

* Experience with cGMP compliance products.

* Experience with cGMP equipment setup and lot runs.

* Knowledgeable with filling out documentation and working within a Quality systems process.

* Able to self-direct and stay on track with multiple concurrent assignments/projects.

* Excellent communication skills; ability to read, write, and speak English

* Basic math and calculation skills.

* Strong interpersonal skills and attention to detail in documentation.

* Manual dexterity with hands and fingers

* Demonstrated experience of operating instruments

* Ability to understand and follow basic documented processes.

* Ability to trouble shoot simple process issues/problems and to communicate with supervisors when they arise.

* Ability to work independently and in a team environment

* Engineering Associate experience a plus

Your day-to-day duties will consist of:

* Operating manual, semi-automated, or automated liquid handling equipment with emphasis on striping solutions onto membranes and/or using dispensing equipment for making small lyophilized beads.

* Other tasks include thorough knowledge and experience in equipment set-up and lot runs.

* Testing activities including quality control tasks to determine bead and/or strip suitability.

* Able to fill out batch records and follow cGMP compliance.

You will need to have:

* High School Diploma or GED

* Associate Degree or equivalent experience in engineering or equipment operation preferred.

We offer a competitive salary, comprehensive benefits including: medical, dental, vision, flex plan, life/disability insurance, 10-paid holidays, 15-days PTO and a 401(k) plan. If you like the start-up environment, have a problem driven mindset, want autonomy working for an innovative company; get ready to roll-up your sleeves and join our team of collaborative people!

Please email resume to humanresources@mesabiotech.com


Title: Senior Process Chemist (Lyophilization)

Location (City, State): San Diego, CA

Overview: Mesa Biotech is a fast growing, ISO certified, FDA approved, medical device company that has achieved a dramatic simplification in the complexity of DNA and RNA molecular testing. Our patented technology provides everything needed to conduct rapid molecular tests at the point-of-care. The palm-sized, reusable dock and disposable test cassette form a user-friendly system for use anywhere, from the physician’s office to the patient’s home.

We are seeking a motivated and independent Senior Lyophilization Process Chemist who will be responsible for developing, scale up and optimizing the dispensing and lyophilization process. Accountable for producing critical product components to include lyophilization, dispensing process and chemical formulation to achieve successful manufacturing of robust diagnostic products.

This position is responsible for set up, scale up and performance optimization of large scale Bioreagent lyophilization components and processes to achieve highest quality and efficiency. Participates in day-to-day operations with responsibilities in optimizing manufacturing process improvements, validation and cost optimization, quality testing, inventory management and labor accountability.

We are looking for someone with experience in:

* Developing, set-up, scale-up and optimizing formulations, and manufacturing processes.
* Develop the operating protocols and documents that meets ISO 13485 and cGMP standards.
* Support the implementation of automation processes to improve manufacturing throughput.
* Adhere to the OSHA safety code and company policies
* Work directly with QA personnel to support ISO 13485 and cGMP certification.
* Lead and develop capacity plan to support production requirements and meet R&D and commercial needs.
* Support internal and external audits when necessary.
* Training junior manufacturing personnel to implement efficient manufacturing work flow
* Equipment Management (Specifications, IQ/OQ/PQ, Calibration and Preventive Maintenance)

You will need to have:

Bachelor’s degree plus a minimum of 8 years of experience in an in-vitro diagnostic industrial setting.

Direct knowledge of manufacturing processes.

Thorough understanding of dispensing processes.

Direct knowledge of lyophilization, conjugation, formulation of IVD diagnostic products.

Thorough knowledge of cGMP requirements to ensure adherence to compliance policies and regulations.

Through knowledge of ISO 13485 regulations and certification.

Ability to perform project management activities and lead small teams.

Thorough knowledge of non-conforming material, corrective and preventive action processes

Knowledge on how to perform process investigations per FDA and ISO standards

Knowledge of risk analysis per FDA and ISO standards

Ability to read, write and speak English.

Experience in setting up, operate, and maintain large scale lyophilizers

Strong written and oral communication skills.

Demonstrates team working competencies and ability to lead the project to meet production schedules.

We offer a competitive salary, comprehensive benefits including: medical, dental, vision, flex plan, life/disability insurance, 10-paid holidays, 15-days PTO and a 401(k) plan.

If you like the start-up environment, have a problem driven mindset, want autonomy working for an innovative company; get ready to roll-up your sleeves and join our team of collaborative people!

Please email resum to humanresources@mesabiotech.com