What are the responsibilities and job description for the Manager/Senior Manager, Risk Management position at Artiva Biotherapeutics?
About Artiva
Artiva is clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies for patients suffering from devastating autoimmune diseases and cancers.
Artiva’s lead product candidate, AlloNK, is a non-genetically modified, off-the-shelf, allogeneic, cryopreserved NK cell therapy designed to enhance the antibody-dependent cellular cytotoxicity (ADCC) effect of mAbs to drive B-cell depletion and to be administered in the community setting. Unlike CAR-T and any genetically modified cell therapy, AlloNK is a non-genetically modified NK cell therapy candidate and has not shown any secondary malignancies in our clinical trials, which is a benefit in an autoimmunity setting. Using the company’s proprietary cell therapy manufacturing platform, Artiva can generate thousands of doses of cryopreserved, infusion-ready AlloNK cells from a single cord blood unit. The FDA has granted Fast Track designation to AlloNK in combination with rituximab or obinutuzumab for the treatment of class III or IV lupus nephritis, and AlloNK in combination with rituximab for the treatment of relapsed or refractory non-Hodgkin lymphoma of B-cell origin (B-NHL).
AlloNK, is currently being evaluated in combination with B-cell targeted mAbs in
patients with autoimmune diseases and cancers, such as lupus nephritis, SLE, rheumatoid arthritis, pemphigus vulgaris, the ANCA-associated vasculitis subtypes GPA/MPA, and B-NHL. In addition, we are also pursuing AlloNK and our CAR-NK product candidates in multiple indications through collaborator-funded trials. Artiva’s cell therapy manufacturing platform incorporates cell expansion and activation technology developed by Artiva’s strategic partner, GC Cell Corporation, a member of the GC family of companies, a leading healthcare company in Korea.
Artiva is headquartered in San Diego and backed by leading venture investors including 5AM Ventures, RA Capital Management and venBio Partners.
For more information, visit www.artivabio.com.
Job Summary:
This position is responsible for developing, managing, and leading the Risk Management Program at Artiva.
Duties and Responsibilities:
- Develop and lead Artiva’s Risk Management Program.
- Identify and evaluate risks within Artiva’s cGMP processes, programs, products, and systems.
- Determine the appropriate risk tools for the analysis and evaluation of different risks.
- Develop risk-based approaches to Quality Systems such deviations, non-conformances, and change controls.
- Create a Product Risk assessment for each Artiva product.
- Lead and facilitate the performance and documentation of cross-functional risk assessments for cGMP programs and functions.
- Manage consultants and contractors as required.
- Write risk management plans, reports, and FMEAs.
- Track and manage risk control action items related to mitigation efforts.
- Maintain databases and metrics.
- Identify and communicate gaps; propose phase-appropriate solutions.
- Support audits by regulatory or state agencies and partners.
- Follow applicable regulations, including FDA, ISO, ICH, and company policies and procedures.
- Support other QA department needs as identified by management.
Requirements:
- Bachelor’s degree or a combination of relevant education and applicable job experience.
- 8 years’ experience in an FDA-regulated industry and cGMP regulations.
- Must have expert-level experience in a Risk Management program.
Why you should apply:
We have a fantastic team and philosophy! We are passionate – we deeply care about our team, our science, and improving the lives of patients. We are tenacious – laser-focused on our mission and undeterred in our commitment to deliver life-saving medicines for cancer patients. We are innovative - pushing into new frontiers for patient benefit. We are transparent - believers in flat, accessible, and open communication paths. We are inclusive – committed to the diversity of our team and ensuring that all voices are heard.
In addition to a great culture, we offer:
· A beautiful facility
· An entrepreneurial, highly collaborative, and innovative environment
· Comprehensive benefits, including:
- Medical, Dental, and Vision
- Group Life Insurance
- Long Term Disability (LTD)
- 401(k) Retirement Plan
- Employee Assistance Program (EAP)
- Flexible Spending Account (FSA)
- Paid Time Off (PTO)
- Company paid holidays, including the year-end holiday week
- Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.
If all this speaks to you, come join us on our journey!
Base Salary: $115,000 - $160,000. Exact compensation may vary based on skills and experience.
Salary : $115,000 - $160,000
