Senior Manager, Quality Control (23017-B-682-QA)
Hayward, CA, USA
Posted on Friday, May 5, 2023
ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Senior Manager, Quality Control 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 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:
- Establish QC strategy for the organization, including QC analytics for raw materials, in-process, and final product
- Ensure timely and accurate release of Arsenal’s cell therapy drug products to support clinical manufacturing
- Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
- Providing and receiving feedback to support the growth and development of team members.
- Provide support for deviations, OOS, change control, investigations, and CAPA Provide support during inspections/audits as a QC subject matter expert
- Provide support with regulatory submissions (IND/BLA)
- Establish team priorities to meet overall project targets and timelines
- Manages employees, contractors and/or consultants, as needed
- 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
- 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
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.
ArsenalBio prioritizes the providing of a safe and healthy workplace that is consistent with COVID-19 public health guidance and legal requirements. In order to protect our employees and visitors, we require all visitors (candidates) and employees to present proof of being fully vaccinated against COVID-19 when coming onsite.
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 $144,700 – $177,200.
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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