Artiva Biotherapeutics

Senior Manager, MSAT

Artiva Biotherapeutics$150K — $165K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's, Master's or PhD in biotechnology, chemical engineering or related fields
  • Proven experience managing complex projects
  • Technical expertise in late-stage clinical and commercial manufacturing
  • Strong communication skills with digital literacy
  • Experience in cell culture, cell therapy or aseptic processing
  • Knowledge in equipment qualification (IQ, OQ, PQ) within GMP
  • Familiarity with investigations and problem-solving methodologies

Responsibilities

  • Provide technical support for process transfers and validation
  • Create Master Batch Records, SOPs and deviation reports
  • Lead deviation processes and conduct Root Cause Analysis
  • Monitor manufacturing processes and troubleshoot issues
  • Author manufacturing investigations and implement CAPA
  • Support raw material characterization and E&L risk assessment
  • Establish a Track and Trend program in collaboration with biostatistics

Benefits

  • Beautiful facility
  • Collaborative and innovative work environment
  • Comprehensive medical, dental, and vision
  • 401(k) Retirement Plan
  • Employee Assistance Program (EAP)
  • Paid Time Off (PTO)
  • Company paid holidays, including year-end holiday week
  • Recognition program to exchange earned points for rewards
Full Job Description
Job Summary: As a member of the MSAT (Manufacturing Science & Technology) organization, you are a key player in the MSAT team supporting Artiva's 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 Engineer's 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, and track and trending manufacturing data. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices. Duties/Responsibilities: 3 Provides technical assistance for process tech transfer and validation efforts for assigned manufacturing projects. 3 Writes Master Batch Records, SOPs, deviation reports and technical risk assessment with a strong understanding of equipment, process and testing 3 Lead deviations process under QA supervision and performs thorough Root Cause Analysis 3 Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed. 3 Author manufacturing investigations and drives CAPA implementation. 3 Support raw materials characterization and E&L risk assessment. 3 Creates dashboard to visualize manufacturing 3 Other duties as assigned. 3 Establish Track and Trend program in collaboration with biostatistics Requirements: 3 Bachelor's, Master's or PhD degree in biotechnology, chemical engineering or related disciplines. 3 Proven experience in managing complex projects. 3 Technical depth & process expertise in late-stage clinical and commercial manufacturing 3 Ability to establish business processes, drive standardization and governance in complex environments 3 Excellent interpersonal, verbal and written communication skills, presentation skills, as well as digital literacy 3 Cell culture, cell therapy or aseptic processing experience 3 Equipment and/or new technology design, qualification and testing experience in a cGMP environment (IQ, OQ, PQ) including process validation 3 Strong understanding of GMP environment and change control processes 3 Experience with investigations and structured problem solving methodologies (e.g., deviations, DMAIC, root cause analysis) 3 Proactive and willing to accept temporary responsibilities outside of initial job description 3 Experience in engineering in highly regulated manufacturing environments In addition to a great culture, we offer: 3 A beautiful facility 3 An entrepreneurial, highly collaborative, and innovative environment 3 Comprehensive benefits, including: 3 Medical, Dental, and Vision 3 Group Life Insurance 3 Long Term Disability (LTD) 3 401(k) Retirement Plan 3 Employee Assistance Program (EAP) 3 Flexible Spending Account (FSA) 3 Paid Time Off (PTO) 3 Company paid holidays, including the year-end holiday week 3 Our recognition program, Bonus.ly, is where you can trade in points earned for things you want. Base Salary: $ 150,000 - $165,000. Exact compensation may vary based on level, skills and experience.

About Artiva Biotherapeutics

Artiva Biotherapeutics is a clinical-stage biotechnology company developing a pipeline of novel, precisely targeted immuno-oncology therapies. The company's proprietary technology platform leverages a deep understanding of the biology of immune cells and their interactions with cancer cells to develop therapies that can selectively activate or suppress immune responses to cancer. Artiva's lead product candidate, AB-101, is a first-in-class, off-the-shelf, allogeneic cell therapy that targets solid tumors by activating natural killer (NK) cells. The company was founded in 2019 and is headquartered in South San Francisco, California.
Learn more about Artiva Biotherapeutics
Size
20 employees
Industry
Net Income
-$16
Founded
2019
NASDAQ

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