Job Description
Job DescriptionSalary: $150,000 - $165,000. Exact compensation may vary based on level, skills and experience.
About Artiva:
We are a clinical-stage biotechnology company focused on developing natural killer (NK) cell-based therapies. Our mission is to develop effective, safe, and accessible cell therapies for patients with devastating autoimmune diseases. We aim to develop therapies that patients and physicians can utilize in a community setting. Our lead product candidate,AlloNK, is a non-genetically modified, cryopreserved NK cell therapy being evaluated in combination with B-cell targeted monoclonal antibodies (mAbs). We believe the compelling cell killing properties of NK cells, when combined with mAbs for targeting, creates an opportunity to generate potentially transformative therapies.
For more information, visitwww.artivabio.com.
Job Summary:
As a member of the MSAT (Manufacturing Science & Technology) organization, you area key player in the MSAT teamsupportingArtivas allogeneic manufacturing processes. The Sr. Manager, MSAT Engineer is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial manufacturing. The Sr. Manager, MSAT Engineers responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, andtrack and trending manufacturing data. These functions will be executed following standard operating procedures and batch recordsin accordance withFDA and EU requirements and current Good Manufacturing Practices.
Duties/Responsibilities:
- Provides technicalassistancefor process tech transfer and validation efforts for assigned manufacturing projects.
- Writes Master Batch Records, SOPs, deviation reportsand technical risk assessmentwith a strong understanding of equipment,processand testing
- Lead deviations process under QA supervision and performs thorough Root Cause Analysis
- Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed.
- Author manufacturing investigations anddrivesCAPAimplementation.
- Support raw materials characterization and E&L risk assessment.
- Creates dashboard tovisualizemanufacturing
- Other duties as assigned.
- Establish Track and Trend program in collaboration with biostatistics
Requirements:
- Bachelors,MastersorPhD degreein biotechnology, chemical engineering or related disciplines.
- Proven experience in managing complex projects.
- Technical depth & processexpertisein late-stageclinical and commercial manufacturing
- Ability toestablishbusiness processes, drivestandardizationand governance in complex environments
- Excellent interpersonal,verbaland written communication skills, presentation skills, as well as digital literacy
- Cell culture, celltherapyor aseptic processing experience
- Equipment and/ornew technologydesign,qualificationand testing experience in a cGMP environment (IQ, OQ, PQ) including process validation
- Strong understanding of GMP environment and change control processes
- Experience with investigations and structuredproblem solvingmethodologies (e.g., deviations, DMAIC, root cause analysis)
- Proactive and willing to accept temporary responsibilities outside ofinitialjob description
- Experience in engineering in highly regulated manufacturing environments
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: $ 150,000 - $165,000. Exact compensation may vary based on level, skills and experience.