Oligonucleotide Formulation Specialist (cGMP)

ELITechGroup - A Bruker Company; Bothell (WA); On-site; USD 36,000 - 47,000; Full time

Job summary

ELITechGroup - A Bruker Company is seeking a biochemical manufacturing support role to formulate oligonucleotide probes and assays, manage inventories, and assist with regulatory documentation in a cGMP environment.

The candidate will dissolve, dilute, and label products, prepare samples for Mass Spectrometry, and maintain lab equipment while contributing to process improvements and SOP updates.

Qualifications

• Bachelor's degree in a scientific discipline with 0-3 years in an FDA-regulated environment, preferably manufacturing or quality control.
• General computer skills using various software applications.
• Experience with NAV software is a plus.

Responsibilities

• Dissolves and dilutes oligonucleotide synthesis products; analyzes concentration; formulates assays (RUO/ASR/EUA/510K); labels products.
• Formulates solution mixes per SOPs and worksheets to prepare finished products.
• Prepares and submits oligo samples for Mass Spec analysis.
• Manages oligo stocks inventory and assists with RUO/ASR/EUA/510K product inventory.
• Manufactures stocks of raw materials and buffers; maintains lab supplies.
• Calibrates and maintains lab equipment as required.
• Updates and writes manufacturing SOPs, SEPCs, worksheets, and related docs to ensure cGMP compliance.
• Initiates and owns quality records (NCs, CAPA) and supports process improvements.

Skills

NAV

General computer skills

Education

Bachelor's degree in chemistry or related field

Tools

Mass Spectrometer

Spectrophotometer

Job description

ELITechGroup - A Bruker Company is seeking a biochemical manufacturing support role to formulate oligonucleotide probes and assays, manage inventories, and assist with regulatory documentation in a cGMP environment.

The candidate will dissolve, dilute, and label products, prepare samples for Mass Spectrometry, and maintain lab equipment while contributing to process improvements and SOP updates.