Senior Process Engineer I (23011-B-680-PS)
Hayward /
Process & Analytical Development /
Full-Time
/ On-site
ArsenalBio, a privately held programmable cell therapy company engineering advanced CAR T therapies for solid tumors, is seeking a talented Senior Process Engineer I 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 talented and motivated Process Engineer to join the ArsenalBio Process Engineering team. The individual will work closely with cross-functional team members to develop, optimize, transfer drug product (i.e. harvest, filling, cryopreservation) processes for GMP manufacturing. They will work closely with Manufacturing Operations, MSAT, and Quality groups to provide manufacturing troubleshooting support, to participate in root cause analyses (RCAs), to perform and document risk/impact assessments and RCAs, and to author change control documents as needed. Additionally, this individual will be responsible for identifying, evaluating, and transferring improvements for drug substance (DS) and drug product (DP) manufacturing processes; and the execution and documentation of DS and DP process characterization and validation studies for later-stage projects and regulatory filings. This position will report into the Process Engineering team lead, and will also interact cross-functionally within Process Sciences (e.g. Analytical Development), Tech Ops (e.g. Manufacturing, Supply Chain, Quality), and across the organization (e.g. Clinical Subteam) to enable the success of ArsenalBio.
What You Will Do:
- Plan, execute, analyze, and report on experiments and analytic assays to support the development, process characterization, and process validation of drug product GMP process to manufacture, characterize, and release T cell therapy products
- Define and execute in-process, product, and in-use stability studies
- Develop and implement process improvements (e.g. process closure) to improve robustness, scalability and COGs of cell therapy products
- Compile documentation (protocols, batch records, and study reports) to facilitate transfer of ArsenalBio’s process to manufacturing sites (e.g. CDMO(s), internal manufacturing site(s))
- Support process FMEAs to understand process and product risks
- Support operational start-up and technology transfer activities, including, generation of risk assessments, manufacturing batch records, standard operating procedures (SOPs), and training materials
- Provide on-the-floor manufacturing operations support and participate in RCAs
- Define, execute, and author process characterization/validation study plans and reports
- Collaborate closely with other functions to enable effective and successful project execution
- Actively engage in cross-functional collaboration with peers to overcome technical challenges
- Organize, communicate, and present complex data sets to key stakeholders and senior management
- Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
- Assist in regulatory documentation authoring and/or review
What You Will Bring:
- PhD, Masters, or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, or Biochemistry)
- 0-2 years experience with PhD or 3+ years with Masters or 5+ years with Bachelors of relevant research experience (cGMP manufacturing, T cell biology and/or immunotherapy preferred)
- Required expertise in T cell process development and flow cytometry
- Understanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process and assay development, qualification, and validation required
- Experience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferred
- Experience working in cGMP environment and within Quality management systems is required
- Prior experience in cell therapy and/or process development teams preferred
- Experience in multi-color flow cytometry analyses including panel design and data analysis requiredExperience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation a plus
- Ability to quickly adapt and learn new skills for changing research priorities
- Flexible mind with the ability to think outside the box, creative approach to problem-solving
- Demonstrated ability to work well in a highly collaborative team environment, coordinate tasks across multiple projects to meet deadlines
- Willingness to accept other responsibilities outside of initial job description
What We Will Offer You:
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.
