Principal Quality Control Specialist (24010-B-682-Qc)

ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Principal Quality Control Analyst to work onsite based in our Hayward office.

ArsenalBio's mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. With our programmable and computationally driven approach, our team is engineering living medicines to attack cancer's inherent multi-faceted nature and overcome the challenges of addressing solid tumors with cell therapy.

Driven by a collective of diverse experts across immunology, synthetic biology, molecular biology, automation and computational biology, we are united in purpose to deliver radical breakthroughs for people with cancer and prioritize the team's outcomes over individual goals to achieve our company mission - together.

We are seeking a talented and motivated leader to join the ArsenalBio Technical Operations Quality team. The individual will provide technical expertise and leadership to the Technical Operations team in overseeing QC/Analytics, and clinical product testing of cell therapy products. The individual will work closely with Quality Operations, Process Development, Analytical Development, and Manufacturing to enable the success of ArsenalBio's clinical scale manufacturing process. The position reports to the Head of Quality Control.

What You Will Do:

• Perform technical review of all analytical testing associated with the batch release, stability and product characterization

• Be a Subject Matter Expert (SME) for the QC assays especially cell-based potency assay

• Support QC testing activities as needed

• Lead and oversee method transfer activities

• Perform QC analysis and analyze results for GMP cell therapy products

• Assist with Contract Testing Lab management

• Interact effectively with cross functional teams to communicate and resolve testing related issues

• Establish team priorities to meet overall project targets and timelines

• Manages employees, contractors and/or consultants, as needed

• Lead/initiate change controls, investigations, and deviations

• Assists other analysts with impact assessments and root cause analysis

• Provide support with regulatory submissions (IND/BLA)

• Provide additional support to other functions, including Quality Operations and QMS, as requested by management, to support project milestones.

• Promote continuous improvement using Lean and Six Sigma principles.

What You Will Bring:

• Bachelor's degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred

• Prior experience working in a GMP analytical laboratory with demonstrated proficiency in cell culture and cell-based potency assays

• Experience with various analytical techniques used in Quality Control Labs including cell culture, bioassays, cytotoxicity and ELISA methods

• Understanding of compliance requirements as it relates to potency assay qualification.

• Prior experience in Quality/Analytics for cell therapy products

• Strong technical writing and verbal communication skills

• Strong critical thinking and problem-solving skills with experience in Root Cause Analysis

• Self-motivated, technically driven, and willing to take on duties out-side of general responsibilities

What We Will Offer You:

An opportunity to work with the best talent in the field of cell therapy and be part of ONE TEAM to advance therapies to patients who need it most.

ArsenalBio has a generous and comprehensive benefits package that includes but is not limited to medical, dental, and vision as well as mental health resources, virtual and telehealth options, coaching, infertility treatment, parental leave and health savings accounts. We also offer flexible work schedules and flexible time off, which includes two extra "Arsenal Days of Rest" every quarter for employees to recharge.

We have a robust mentorship program, and comprehensive development tools to help employees take control of their career paths and grow into their best selves. ArsenalBio believes in investing in the well-being of our employees - both at work and at home, as they are our greatest asset. They bring scientific talents in molecular biology, immunology, pharmacology, protein chemistry, computational biology, automation, genome engineering, software and other fields to make the future happen now.

We are committed to hiring the best talent from diverse backgrounds. A diverse workforce engenders richness of thought, creativity and discovery. We invite individuals who embrace intellectual achievement to bring their unique personal and professional journeys and together we will build transformative cell therapies for cancer patients.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

The estimated base salary offer for the preferred primary location of San Francisco Bay area ranges from $127,300 - $156,000. Salary ranges for other locations may vary from this range. Base pay offered may vary depending on job related knowledge, experience, education, and location. In addition to these factors, we believe in the importance of pay equity and consider internal equity of our current employees as part of any final offer.

To all recruitment agencies: ArsenalBio does not accept agency resumes. Please do not forward resumes to our jobs alias, or ArsenalBio employees. ArsenalBio is not responsible for any fees related to unsolicited resumes.

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