Associate II, Quality Control Biology (Temporary)

Artiva Biotherapeutics; San Diego (CA); On-site; USD 74,000 - 85,000; Full time

Job summary

Artiva Biotherapeutics is seeking a QC Associate II, QC Biology (Temporary) to perform routine cGMP release and stability testing of NK cell therapy products. You will support investigations, write reports, and help improve QC systems under supervision.

The role requires a BS/BA in biology or related field and at least 2 years of cGMP QC experience in a biotech/pharmaceutical setting. Base salary ranges from $74,000 to $85,000 annually.

Qualifications

• Minimum 2 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting.
• Strong documentation practice and ability to write deviations and OOS investigations.
• Knowledge of method transfers, validations, and regulatory guidance interpretation.

Responsibilities

• Assist in ordering supplies, reagents and equipment.
• Write and revise SOPs/Test methods that support Artiva’s cell therapy products.
• Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Support activities for QC equipment IQ/OQ/PQs.
• Perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
• Support and as needed evaluate QC systems and/or implement system improvements with supervision.
• Support laboratory investigations and write reports for deviations and Out of Specification results.
• Document lab work in a thorough and accurate manner.

Skills

cGMP QC experience

Technical writing

Critical thinking

Microsoft Word / Excel

Education

Bachelor’s degree in Biology or related field

Tools

ELISA

Flow Cytometry

Automated cell counters

IQ/OQ/PQ

Microsoft Word

Microsoft Excel

Job description

About Artiva: We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate, AlloNK® , is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.

For more information, visit www.artivabio.com.

Job Summary:

Artiva Biotherapeutics is seeking a skilled and motived QC Associate II, QC Biology (Temporary) who will be reporting to the Associate Director, Quality Control. This individual will perform routine cGMP release and stability testing of Artiva's NK cell therapy products, support laboratory investigations, and contribute to continuous improvement of QC systems. The contract will be through the end of the year with possible extension beyond that.

Duties/Responsibilities:

• Assist in ordering supplies, reagents and equipment.
• Write and revise SOPs/Test methods that support Artiva’s cell therapy products.
• Operate and test ELISA, Flow Cytometers, automated cell counters, and other analytical instruments and equipment, as needed.
• Support activities for QC equipment IQ/OQ/PQs.
• Perform routine cGMP release and stability testing of Artiva’s products; including biological tests, biochemistry, chemistry-based tests as needed.
• Support and as needed evaluate QC systems and/or implement system improvements with supervision.
• Support laboratory investigations and write reports for deviations and Out of Specification results.
• Document lab work in a thorough and accurate manner.
• Perform all work according to company policies, SOPs, and cGMP practices.
• Assist in planning for GMP release testing, including testing schedules, reviewing biology data and investigating OOS and OOT results.
• Write technical QC protocols and reports as needed.
• Assist in analytical qualification and validation, as necessary.
• Support the transfer and optimization of analytical methods from Analytical Development (or contract laboratories).
• Develop an in-depth understanding of NK products, testing, and safety.
• Maintain records and databases in accordance with procedures.
• Support other special QC projects as needed.

Qualifications:

• Bachelor’s degree (BS/BA) or relevant scientific field, preferably in biology or related field.
• Minimum 2 years of cGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• Knowledge and experience in supporting cGMP deviations, OOS, etc.
• Basic knowledge of method transfers, qualifications, and validations; current industry practices; and some experience with guidance interpretation and application
• Adept at learning critical thinking and technical writing skills.
• Computer skills required to operate Microsoft Word and Excel programs.

Base Salary: $ 74,000 - $ 85,000. Exact compensation may vary based on level, skills and experience.