Arsenal Biosciences
Senior Manager, Quality Control (24205-U-682-QC)
Arsenal Biosciences, Hayward, California, us, 94557
Senior Manager, Quality Control (24205-U-682-QC)
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 Senior Manager, Quality Control 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
Establish QC strategy for the organization, including QC analytics for raw materials, in-process, and final productEnsure timely and accurate release of Arsenal’s cell therapy drug products to support clinical manufacturingMake sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriateProviding and receiving feedback to support the growth and development of team membersProvide support for deviations, OOS, change control, investigations, and CAPAProvide support during inspections/audits as a QC subject matter expertProvide support with regulatory submissions (IND/BLA)Establish team priorities to meet overall project targets and timelinesManage employees, contractors and/or consultants, as neededProvide additional support to other functions, including Quality Operations and QMS, as requested by management, to support project milestonesPromote continuous improvement using Lean and Six Sigma principlesWHO YOU ARE
Bachelor’s degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred4+ years progressive management experience and proven leadership skills managing a quality control functionStrong knowledge of cGMP/ICH/FDA/EMA regulationsPrior experience in Quality/Analytics for cell therapy productsIn-depth knowledge of QE principles, concepts, industry practices, and standardsStrong technical writing and verbal communication skillsStrong critical thinking and problem-solving skillsAbility to prioritize deliverables for the overall good of the projectAbility to work in cleanroom environmentsBENEFITS 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 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 $144,700 – $177,200. Salary ranges for other locations may vary. Base pay offered may vary based on job-related knowledge, experience, education, and location.
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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 Senior Manager, Quality Control 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
Establish QC strategy for the organization, including QC analytics for raw materials, in-process, and final productEnsure timely and accurate release of Arsenal’s cell therapy drug products to support clinical manufacturingMake sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriateProviding and receiving feedback to support the growth and development of team membersProvide support for deviations, OOS, change control, investigations, and CAPAProvide support during inspections/audits as a QC subject matter expertProvide support with regulatory submissions (IND/BLA)Establish team priorities to meet overall project targets and timelinesManage employees, contractors and/or consultants, as neededProvide additional support to other functions, including Quality Operations and QMS, as requested by management, to support project milestonesPromote continuous improvement using Lean and Six Sigma principlesWHO YOU ARE
Bachelor’s degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred4+ years progressive management experience and proven leadership skills managing a quality control functionStrong knowledge of cGMP/ICH/FDA/EMA regulationsPrior experience in Quality/Analytics for cell therapy productsIn-depth knowledge of QE principles, concepts, industry practices, and standardsStrong technical writing and verbal communication skillsStrong critical thinking and problem-solving skillsAbility to prioritize deliverables for the overall good of the projectAbility to work in cleanroom environmentsBENEFITS 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 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 $144,700 – $177,200. Salary ranges for other locations may vary. Base pay offered may vary based on job-related knowledge, experience, education, and location.
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