Senior Process Engineer I (24115-R-680-PS)
Hayward
Process & Analytical Development /
Full-Time /
On-site
WHO WE ARE
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 Principal Quality Control Specialist 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 Process Engineer to join the ArsenalBio Process Engineering team. The individual will work closely with cross-functional team members to develop, optimize, transfer 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’LL 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 including 1) Actively engage in cross-functional collaboration with peers to overcome technical challenges, and 2) Assist cross-functional activities including hand-offs to various teams, compiling data, and presenting at project meetings
- Organize, communicate, and present complex data sets to key stakeholders and senior management
- Assist in regulatory documentation authoring and/or review
WHO YOU ARE
- PhD, Masters, or Bachelors in a relevant scientific discipline (such as Biotechnology, Bioprocess engineering, Immunology, Molecular Biology, or Biochemistry)
- PhD or Masters with 3+ years or Bachelors with 5+ years relevant research experience (cGMP manufacturing, T cell biology and/or immunotherapy preferred)Expertise in T cell process development and flow cytometry
- Experience in multi-color flow cytometry analyses including panel design and data analysis
- Experience in T cell functional assays including cytotoxicity, cytokine/chemokine, and proliferation is a plus
- Understanding of and experience with cGMP environment, Design of Experiment (DOE), and Quality by Design (QBD) principles for process development, qualification, and validation
- Experience working in cGMP environment in supporting equipment set-up, commissioning, qualification is preferred
- Experience working in cGMP environment and within Quality management systems
- Prior experience in cell therapy and/or process development team is 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
BENEFITS 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 have robust 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 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 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 $127,300–$156,000. Salary ranges for other locations may vary. Base pay offered may vary based 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.
