Job Description

Department: Manufacturing Operations
Location: Weston, FL

The Technical Process and Manufacturing Specialist is responsible for the production, optimization, and quality verification of complex finished goods and specialty materials in a regulated laboratory manufacturing environment. This role supports established batch records and standard operating procedures, performs technical calculations, prepares formulations, and ensures product performance and consistency. The position involves operation and troubleshooting of analytical instrumentation, process adjustments to maintain specifications, and execution of in vitro diagnostic (IVD) manufacturing tasks. Experience with immunoassay systems, clinical analyzers, and scientific production workflows is highly desirable.

Key Responsibilities

· Write, revise, review, and support controlled documentation related to manufacturing, process improvement, and quality activities

· Calibrate, maintain, troubleshoot, and operate scientific instruments, including:

• pH meters

• Spectrophotometers

• Dissolved oxygen meters

• Centrifuges

• Clinical chemistry analyzers

• Immunochemistry analyzers

· Perform technical calculations and apply statistical methods to support process control

· Work with human and animal serum, plasma, and biological materials

· Operate within a biological safety cabinet using proper aseptic technique

· Execute analytical laboratory and process manufacturing tasks supporting production, development, and optimization initiatives

· Comply with Good Manufacturing Practices (cGMP), Good Laboratory Practices (GLP) & SOPs

· Maintain accurate, compliant approved batch record documentation within controlled systems

· Collaborate cross-functionally with Manufacturing, Production, Purchasing, and QA/QC teams

· Participate in troubleshooting, process improvement, and cross-functional projects

· Maintain laboratory cleanliness and manage biohazardous and non-biohazardous waste

· Perform additional duties as required

Qualifications

To perform successfully in this role, the individual must:

• Execute essential duties in a regulated manufacturing environment

• Interpret technical and scientific documentation

• Write controlled documents, SOPs, reports, and protocols in prescribed formats

• Demonstrate strong attention to detail and process discipline

• Possess working knowledge of Microsoft Word, Excel, and Outlook

Education & Experience

• Bachelor’s degree in Chemistry, Biology, Biotechnology, Biomedical Sciences, or related technical discipline preferred

• Relevant laboratory, manufacturing, or diagnostic production experience may be considered in lieu of a degree

• Associate degree combined with applicable industry experience will also be considered

Physical Requirements

• Ability to stand for extended periods

• Ability to lift and/or move up to 50 pounds occasionally

• Ability to work in cold storage environments at times

• Ability to work with human biological samples

Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Compensation & Benefits

This is a full-time, exempt position. Compensation is based on qualifications, experience, and internal equity. Occasional overtime and weekend work may be required.

Benefits include:

Medical, dental, and vision insurance, Company Paid Life insurance, 401(k), Paid time off

Work Environment

The work environment characteristics described here are representative of those encountered while performing the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions. The noise level in the work environment is typically moderate. This position requires working with human biological samples. Tasks may occasionally expose the employee to extreme cold conditions.

About Us

Medix Biochemica is a rapidly growing in vitro diagnostics (IVD) company with Finnish roots and global operations. We operate across multiple international locations:

• Espoo, Finland

• St. Louis, Missouri

• Weston, Florida

• Shanghai, China

• Besancon, France

• Konstanz, Germany

We develop, produce, and supply high-quality IVD raw materials that enable customers worldwide to deliver accurate results to billions of patients. Our recent strategic acquisitions have expanded our portfolio, making us one of the most comprehensive raw material partners in the global IVD industry.

With more than 250 colleagues worldwide, our values guide everything we do:

We Care. We Dare. We Deliver.