Formulation Manufacturing Associate

Job Title

Formulates oligonucleotide probes, primers and assays (RUO, ASR, EUA & 510K). Manages oligo stocks inventory. Assists Manager in managing RUO, ASR, EUA and 510K products inventory.

Essential Duties and Responsibilities

Dissolves and dilutes oligonucleotide synthesis products, analyzes concentration, formulates assays (RUO, ASR, EUA & 510K), prints labels according to specifications and apply labels to product tubes.

Formulate solutions mixes according to SOPs and Work Sheets (WS) to prepare finished products.

Prepare and submit oligo samples for Mass Spec analysis.

Manages oligo stocks inventory.

Assists Director/Manager in managing RUO, ASR, EUA and 510K products inventory.

Manufactures stocks of raw materials and buffers, and maintains lab supplies, etc.

Calibrates and maintains lab equipment as required.

Makes inventory corrections and consumptions in NAV.

Writing manufacturing operating procedures that are technically sound, promote effective and efficient operations, and comply with cGMP requirements. Edit SOP, SEPC, Work Sheet and related documentation when needed.

Initiating and owning quality records, including but not limited to non-conformances (NC), Corrective/Preventative (CAPA).

Provides input to process improvements and assists with the development of new and/or improved manufacturing procedures.

Assists with related special projects, as required.

Qualifications

Bachelor's degree (B.S.) in a scientific discipline (chemistry, molecular biology, biochemistry or related field) from four-year college or university with 0-3 years of experience including relevant industry experience in an FDA regulated company preferably in manufacturing and/or quality control.

General computer skills utilizing various software applications.

Experience in NAV

Preferred

Experience with Mass Spectrometer and/or spectrophotometer plate reader.

Proven knowledge of cGMP requirements to ensure compliance.