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

ArsenalBio

ArsenalBio

Quality Assurance
Hayward, CA, USA
Posted on Tuesday, April 16, 2024
WHO WE ARE
Arsenal Biosciences Inc. is a clinical stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We are seeking a talented and experienced Principal Quality Control Specialist to work onsite based in our Hayward office.
ArsenalBio’s mission and purpose is very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering medicines with the goal to attack cancer’s inherent multifaceted nature and overcome the challenges of addressing solid tumors with cell therapy.
Driven by a collective of diverse experts across multi-scientific disciplines as well as clinical and manufacturing expertise, we are united in our purpose to develop the optimal medicines for improving patients’ lives.
This means you’ll have the opportunity to work with the best talent in the field of cell therapy, and be part of ONE TEAM advancing therapies for patients who need it most.
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’LL 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.

WHO YOU ARE

  • Bachelor’s degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred
  • 4+ years progressive management experience and proven leadership skills managing a quality control function
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Prior experience in Quality/Analytics for cell therapy products In depth knowledge of QE principles, concepts, industry practices, and standards Strong technical writing and verbal communication skills
  • Strong critical thinking and problem-solving skills
  • Ability to prioritize deliverable for the overall good of the project
  • Ability to work in cleanroom environments
BENEFITS AND PAY
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.
Our people-first culture fosters a deep appreciation for humanity, both in the people we endeavor to serve as well as each other. We are proud to work for a company that is driven by diversity in experiences, ideas and interests, and one that empowers us in an environment that embraces both unity and inclusivity.
We have robust 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 our people 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 for the preferred primary location of the San Francisco Bay area ranges from $127,300 - $156,000. Salary ranges for other locations may vary. Base pay offered may vary based 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.