ArsenalBio’s mission is to develop efficacious and safe cellular therapies for patients with chronic diseases, initially cancer. Our products are being designed to herald the transition of adoptive cell therapy from a hospital based treatment to outpatient therapy, like most other cancer treatments.
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 seeking a talented and motivated QC Associate to join the ArsenalBio Technical Operations Quality team. The individual will support the manufacturing environmental monitoring program and QC microbiology, as well as QC laboratory operations including support of analytical technology transfer and 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: Support/manage the environmental monitoring program for the GMP manufacturing areas, including coordination of sample collection, testing, and compilation of EM data.Oversight/coordination of external microbiological testing, including EM, Sterility, and Mycoplasma. Participate in the analytical tech transfer of methods from Analytical Development to QC Perform QC analysis and analyze results for GMP cell therapy productSupport QC laboratory operations, including:
- QC laboratory design and implementation discussions
- Establishment of material and product specifications
- Management of deviations, OOS, change control, investigations, and CAPA
- General laboratory set-up and support
- Support during inspections/ audits/ regulatory submissions (IND/BLA) Provide additional support to other functions, as requested by management, to support project milestonesPosition will require travel between manufacturing and testing locations in the San Francisco Bay Area, including San Francisco and Hayward.
What You Will Bring: Bachelor’s degree or advanced degree in relevant scientific field or discipline3+ years of experience in biotechnology/pharmaceutical industry Prior experience and QC analytical expertise in environmental monitoring or microbiologyPreferable additional experience in one or more methods common in the cell therapy industry, ie. Cell based assays, PCR/RT-PCR, flow cytometry (10+ multi-color)Knowledge of cGMP/ICH/FDA/EMA regulationsStrong technical writing and verbal communication skillsStrong critical thinking and problem-solving skillsAbility to work in GMP manufacturing clean room environments (ISO-7 clean room gowning)Self-motivated, technically driven, and willing to take on duties out-side of general responsibilities
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 (including 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.
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.