Associate II, Quality Control Biology

Artiva Biotherapeutics, Inc.; San Diego (CA); On-site; USD 79,000 - 91,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Group Life Insurance

Long-Term Disability (LTD)

401(k) Retirement Plan

Employee Assistance Program (EAP)

Flexible Spending Account (FSA)

Paid Time Off (PTO)

Company-paid holidays

Bonus.ly recognition program

Job summary

Artiva Biotherapeutics, Inc. is seeking an Associate II, Quality Control Biology to perform routine cGMP release and stability testing on NK cell therapy products.

You will support investigations, assist in SOPs, and contribute to QC system improvements within a collaborative lab environment. The role requires a BS/BA in biology or related field and at least 2 years of cGMP QC experience in biotech/pharma, with strong writing and technical skills to document results and support deviations and

Qualifications

• Minimum 2 years of cGMP QC experience in cell therapy/biotech/pharma.
• Knowledge of deviations, OOS and related investigations.
• Experience with method transfers, qualifications and validations.
• Strong technical writing and critical thinking skills.
• Proficient with Word and Excel.

Responsibilities

• Assist in ordering supplies and equipment.
• Write and revise SOPs and test methods.
• Operate ELISA and cytometry instruments as needed.
• Support IQ/OQ/PQ activities for QC equipment.
• Perform routine cGMP release and stability testing.
• Document work and write deviation/Out of Specification reports.
• Plan GMP release testing and review biology data.
• Support transfer and qualification of analytical methods.

Skills

2 years cGMP QC exp

biology background

critical thinking

technical writing

MS Word/Excel

Education

Bachelor’s degree in biology or related field

Tools

ELISA

Flow Cytometers

Automated cell counters

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, create an opportunity to generate potentially transformative therapies.

For more information, visit

www.artivabio.com.

Summary:

Artiva Biotherapeutics is seeking a skilled and motivated Associate II, Quality Control Biology who will be reporting to the Associate Director, Quality Control Biology. 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.

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 QC equipment IQ/OQ/PQ activities.
• Perform routine cGMP release and stability testing of Artiva’s products, including biological tests, biochemistry, and chemistry-based tests as needed.
• Support as needed to 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) in a relevant scientific field, preferably in biology or a 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.

In addition to a great culture, we offer:

• A beautiful facility
• An entrepreneurial, highly collaborative, and innovative environment
• Comprehensive benefits, including:
• Medical, Dental, and Vision
• Group Life Insurance
• Long-Term Disability (LTD)
• 401(k) Retirement Plan
• Employee Assistance Program (EAP)
• Flexible Spending Account (FSA)
• Paid Time Off (PTO)
• Company-paid holidays, including the year-end holiday week
• Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.

If all this speaks to you, come join us on our journey!

Base Salary: $ 79,000 - $ 91,000. Exact compensation may vary based on level, skills, and experience.

NO AGENCIES PLEASE