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Senior Quality Control Specialist (24011-B-682-QC)

ArsenalBio

ArsenalBio

Quality Assurance
Hayward, CA, USA
Posted on Wednesday, January 10, 2024
ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Senior Quality Control Specialist I 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 multifaceted 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 Senior QC Specialist to join the ArsenalBio Technical Operations Quality team. The individual will support analytical technology transfer and perform analytical QC testing for clinical-phase cell therapy products within the ArsenalBio GMP QC organization. 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. This position will report to the Head of Quality Control.

What You Will Do:

  • Participate in the analytical tech transfer of methods from Analytical Development to QC, providing subject matter and GMP QC perspective and expertise
  • Partner with Analytical Development and ensure analytical methods are implemented and qualified/validated to a phase appropriate GMP state
  • Perform QC analysis and analyze results for GMP cell therapy product
  • Support QC laboratory design and implementation decisions
  • Support establishment of material and product specifications
  • Support deviations, OOS, change control, investigations, and CAPA
  • Support team during inspections/audits as a QC subject matter expert, as needed
  • Support team with regulatory submissions (IND/BLA), as needed
  • Provide additional support to other functions, as requested by management, to support project milestones

What Will You Bring:

  • Bachelor’s degree or advanced degree in relevant scientific field or discipline
  • 5+ years of experience in biotechnology/pharmaceutical industry
  • Prior experience and QC analytical expertise in Cell Culture, cell based assays, ELISA is highly desirable
  • Knowledge of cGMP/ICH/FDA/EMA regulations
  • Strong technical writing and verbal communication skills
  • Strong critical thinking and problem-solving skills
  • Ability to work in GMP QC clean environments
  • 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 $93,500–$114,500. 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.