Associate Director, Process Development
Over the past decade we have seen important advances in the cellular immunotherapy therapy field in particular, with dramatic rates of clinical response in hematological malignancies, and rapid evolution of our understanding of factors that could extend this success to solid tumors. However, these transformative therapies are often accompanied by severe and potentially life-threatening toxicities, and patient access is limited by such factors as complex, time-consuming patient-specific manufacturing, variable product quality, and cost.
At Artiva, our mission is to deliver highly effective cell therapies that are also safe and immediately available and accessible to any patient who stands to benefit.
Reporting to the Senior Director, CMC, the Associate Director, Process Development will lead the development, improvement and optimization of processes leading to advancement of Artiva’s off the shelf NK cell pipeline.
Role & Responsibilities
- Design, execute, and analyze experiments to develop, optimize, and evaluate process-related improvements to Artiva’s NK cell therapy platform for novel off- the-shelf products.
- Analyze and evaluate in-process and endpoint phenotypes of cord blood derived NK and CAR-NK cells using multi-parameter flow cytometry.
- Assess in vitro function of NK cells, including proliferation, cytokine secretion, and target cell killing, using standard assays and assist in the development of novel assays as required.
- Development of manufacturing batch records and other documents required for GMP cell therapy production.
- Work alongside the In Vivo Pharmacology Team in providing material for In Vivo assays as required.
- Optimize previously established methods to support IND-enabling activities, including engineering lot production, release, stability, and characterization.
- Follow good documentation and review practices and maintain current and accurate experimental and material records.
- Effectively communicate development strategies and results in presentations and written reports.
- Develop effective tech. transfer methods and procedures to ensure successful tech transfer to both internal and external manufacturers.
Experience, Education and Specialized Knowledge and Skills
Must thrive working in a fast-paced innovative environment while remaining flexible, proactive, resourceful, and efficient. Ability to manage complex process development functions and timelines through outsourced or partnered workflows is a requirement. Excellent interpersonal skills, ability to develop important relationships with key stakeholders, conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans and recommendations. Demonstrated ability to translate strategy into action. Excellent analytical skills, ability to communicate complex issues in a simple way, and ability to orchestrate plans to resolve issues and mitigate risks.
- B.S / M.S. Degree in Cell Biology, Stem Cell Biology, Immunology, or related field with a minimum of 7 years of relevant bench-level experience in an academic, biotechnology, or pharmaceutical setting.
- Proficiency with aseptic techniques for working with mammalian cell culture.
- Expert in working with CliniMACS, Sartorius, Aseptic Technologies and other process platforms required
- Hands-on experience with flow cytometry-based assay execution and analysis; experience with 8+ colors is a plus.
- Prior experience with cell-based functional assays, including proliferation, cytokine secretion, and target cell killing, is desirable.
- Expertise in cellular biology, especially stem cell biology, T cell biology, or NK cell biology, is a plus.
- Experience with tech transfer, development of manufacturing batch records, release specifications and with evaluation of materials used in GMP manufacture
- Proficiency in experiment execution, data analysis, and troubleshooting.
- Excellent written and oral communication skills. An ability to succinctly communicate experimental findings will be highly valued.
- Careful attention to detail and strong analytical and problem-solving skills.
- Positive outlook, engagement, and interest in testing and implementing new ideas.
- Ability to work independently and effectively in a fast-paced team environment, as well as to prioritize activities from multiple projects with little supervision.
- Decision Making
- Risk Management
- Time Management
- Business Planning
- Strategic thinker
- Implementing Plans
- CRO Management
- Analysis & Reporting
- Leadership & Team Development
- Forward thinking
We look for talented, entrepreneurial people who share our values.
We are called to put the safety of our patients and employees first, and to act with integrity and the highest ethical standards. To achieve our mission, we must collaborate across the Company at all levels, and we must hold ourselves and our teams accountable for delivering the progress we commit to, on the timelines we set. We embrace diversity, we include people and their ideas, and we aspire to excellence by listening, understanding, sharing, and responding. We want you to be fully engaged, to develop personally and professionally through this chapter in your life, and to have fun along the way.
Artiva Biotherapeutics is an equal opportunity employer that is committed to providing a work environment free of harassment and discrimination based upon a protected category, as well as an environment free from retaliation for protected activity.
- The opportunity to work with a team of highly experienced professionals from clinical to regulatory to CMC to research
- To be part of building a company on the cutting edge of cell therapy that may be a game changer to patients in a culture that is entrepreneurial, highly collaborative, and innovative
- Competitive compensation, including bonus
- Equity program
- Health and welfare benefits – Medical, Dental, Vision, Life, 401K, EAP