About the position
Arsenal Biosciences Inc. is a clinical-stage programmable cell therapy company engineering advanced CAR T-cell therapies for solid tumors. We seek a talented and experienced Sr. Manager, Quality Engineering & Validation (QA for QC) to work onsite based in our Hayward office. ArsenalBio’s mission and purpose are very clear: defeat cancer. With our programmable and computationally driven approach, our team is engineering 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 multi-scientific disciplines and 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, which advances therapies for patients who need it most.
Responsibilities
- Partner with Quality Control group to determine phase appropriate commissioning, qualification, and validation strategies
- Review and approve C&Q documentation for technical soundness and compliance
- Provide oversight for C&Q related activities
- Review and approve QC Quality records, procedures, protocols, and reports as Quality Assurance
- Provide support for deviations, change control, investigations, and CAPA, as needed
- Author, review, and/or approve process validation lifecycle documents, as needed
- Participate in Risk Assessments and facilitate as needed
- Promote a Quality mindset and continuous improvement
- Provide support with regulatory submissions (IND/BLA), as needed
- Provide support during internal and external inspections / audits, as needed
- Provide additional support to other functions, as requested by management, to support project milestones
Requirements
- Bachelors or Masters in relevant scientific field or discipline
- 8+ years of experience in biotechnology/pharmaceutical industry
- In depth knowledge of analytical methods used in QC
- Prior experience in Quality for cell therapy products
- Strong knowledge of cGMP/ICH/FDA/EMA regulations
- 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
- Self-motivated, technically driven, and willing to take on duties outside of general responsibilities
- Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
Nice-to-haves
- Ability to work in cleanroom environments
- Prior experience working in ASAT (Analytical Sciences & Technology)
Benefits
- Medical, dental, and vision insurance
- Mental health resources
- Virtual and telehealth options
- Coaching
- Infertility treatment
- Parental leave
- Health savings accounts
- Flexible work schedules
- Flexible time off, including two extra 'Arsenal Days of Rest' every quarter
