ArsenalBio, a privately held, clinical-stage programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Senior Manufacturing Engineer – Manufacturing Technical Services to work On-Site 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 multi-faceted 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 Sr. Manufacturing Engineer - Technical Services to support our clinical Manufacturing team at ArsenalBio.
Under minimal supervision, this position’s main accountabilities are focused on the front-line technical support of manufacturing operations while closely collaborating with the Quality and Product Sciences Unit.
What You Will Do:
- Complete required training to maintain technical skill, knowledge, and compliance with cGMP requirements and Manufacturing curriculum.
- Provide technical support for the manufacturing process, including process investigations, process changes, and technology transfer
- Provide support to Process Sciences, QE, QC, MFG, QA, and Facilities through participation on cross functional teams
- Lead activities on identifying, accessing, and executing appropriate CAPA for resolution of root cause related to Manufacturing process.
- Analysis of manufacturing process data
- Investigates and coordinates the resolution of deviations through comprehensive use of Root Cause Analysis tools
- Conducts Risk Assessments/FMEA to support manufacturing activities including manufacturing process changes and technical transfers
- Collaborate With stakeholders to write and/or revise SOPs, batch records, technical reports, and other operational related documents as support is needed
- Analyze and resolve moderately complex Manufacturing and Compliance issues (e.g., CAPA, non-conformances, audit observations)
- Support regulatory submissions and Quality Assurance with technical content and expertise
- Other tasks and duties as assigned by Management
What Will You Bring:
- Bachelor’s degree in relevant scientific or engineering discipline with 7+ years of experience in engineering, manufacturing and quality in biotech/pharma industry or Masters degree with 4+ years of relevant experience.
- Strong understanding of the Manufacturing Process
- Strong skill in technical writing
- Strong skill in CAPA development and management
- Experience in cell culture or aseptic processing
- Experience in cGMP cell therapy manufacturing
- Strong knowledge of pharmaceutical manufacturing of biotechnology products and process development
- Ability to share complex principles of knowledge to others
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 $126,100 –$154,500.
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.