Manufacturing Associate 1

We are seeking a disciplined, detail-oriented, and highly motivated Manufacturing Associate I for a temporary assignment supporting the formulation and manufacture of biological and chemical reagents. The role will also handle temperature-sensitive, high-concentration antigens where strict contamination control, aseptic technique, accurate pipetting, and careful temperature management are critical to maintaining material integrity and preventing cross-contamination. Experience in reagent formulations under Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) in a regulated industry is highly preferred.

Responsibilities:

• Formulate biological and chemical reagents in accordance with manufacturing batch records (MPRs), standard operating procedures, and other applicable Quality System policies.
• Perform antigen reconstitution, dilution, mixing, aliquoting, and storage activities using approved procedures and designated equipment.
• Maintain temperature-sensitive materials under specified storage and handling conditions throughout manufacturing activities.
• Assist with other high-priority manufacturing activities, including special builds, filling, labeling, and packaging, as assigned.
• Complete MPRs and associated manufacturing records accurately and in accordance with Good Documentation Practices (GDP).
• Track and maintain inventory of consumables and raw materials required for manufacturing.
• Participate in general laboratory maintenance such as basic equipment calibration and maintenance, general cleaning of facility, cleaning of labware, and routine laboratory housekeeping.
• Support troubleshooting to investigate and resolve manufacturing issues.
• Support routine inventory cycle count.
• Maintain a safe working environment and comply with all applicable laboratory safety practices.

Required Qualifications:

• Bachelor's degree in Biological Science, Biochemistry, Chemistry, Bioengineering, or a related field with one to two years of experience in reagent manufacturing.
• Demonstrated proficiency with micropipettes and routine molecular biology laboratory techniques.
• Demonstrated ability to follow detailed SOPs, MPRs, and work instructions and maintain complete and accurate records.
• Understanding of aseptic technique and prevention of cross-contamination. Direct experience handling proteins, antibodies, antigens, or other temperature-sensitive biological materials is strongly preferred.
• Ability to perform calculations and accurately execute small-volume liquid handling, dilutions, aliquoting, and material reconciliation.
• Strong attention to detail, organization, and problem-solving skills, with the judgment to stop work and escalate unexpected conditions.
• Ability to work effectively both independently and as part of a team in a fast-paced manufacturing environment.
• Strong verbal and written communication skills.
• Experience in an ISO 13485, GMP, or other regulated environment is preferred.

The base salary range for this full-time position is $35 - $40/hour.