Serologist I

Position Summary

The Serologist I is responsible for performing a variety of serological and chemical testing activities in support of the Formulation Department.

• This role includes preparation of antibody dilutions, formulation of buffers and solutions, equipment cleaning and maintenance, and adherence to regulated manufacturing procedures.

Key Responsibilities

• Perform serological and chemical testing of formulation intermediates (e.g., antibody dilutions, gel bottle products)
• Prepare dilutions of monoclonal and polyclonal antibodies
• Formulate buffers and solutions according to approved procedures
• Perform gel treatment processes (e.g., addition of Sodium Azide and antibodies to gel)
• Conduct manual and automated cleaning, assembly, inspection, and issuance of manufacturing equipment
• Perform verification and maintenance of the DI Water System
• Conduct daily and weekly maintenance of automated washers
• Perform instrument calibration and maintenance
• Execute chemistry testing of intermediates within formulation
• Open nonconformances, prepare investigations, and support continuous improvement projects
• Perform QC incoming receipt and inspection of raw materials
• Complete all documentation in compliance with GMP requirements
• Perform other work-related duties as assigned

Key Stakeholders

• Manufacturing
• Quality Control
• Microbiology
• Quality Assurance
• Engineering
• Product Support
• Materials Management

Required Qualifications

• Associate of Science degree in Medical Technology, Biology, Chemistry, or related field
• Minimum of 1 year experience in a medical or manufacturing facility (or equivalent combination of education and experience)
• Experience with chemical and/or biological formulations
• Manual dexterity for equipment processing and cleaning
• Ability to stand for extended periods and perform repetitive motions
• Strong verbal and written communication skills
• Basic proficiency in Microsoft Office (Excel, Word, Outlook)
• Ability to prioritize and manage multiple tasks simultaneously
• Ability to work independently and in a team environment

Preferred Qualifications

• At least 1 year of experience in a regulated production environment
• Knowledge of Good Manufacturing Practices (GMP)
• Familiarity with FDA, OSHA, ISO, and cGMP regulations
• Commitment to workplace safety and advocacy for safe work practices