Manufacturing Associate
Artiva Biotherapeutics
4 hours ago
On-site
San Diego, CA
Operations
Job Summary
- The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in a new cGMP facility. Develop and adhere to SOPs for GMP facility operations, equipment/facility monitoring, and internal manufacturing of cell therapies across multiple programs.
Duties/Responsibilities
- Assist in setting up cGMP manufacturing suites and equipment/fixtures as needed.
- Perform facility and equipment monitoring activities.
- Assist in authoring manufacturing SOPs and batch production records that comply with cGMP requirements.
- Perform cGMP manufacturing and support operations described in SOPs and batch records across multiple programs.
- Complete documentation required by process tech-transfer protocols, validation protocols, SOPs, and batch records (cGDP standards).
- Perform tasks consistent with safety policies, quality systems, and GMP requirements.
- Complete training assignments and qualifications for GMP manufacturing and related process technical skills.
Required Skills & Experience
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
- Minimum 2 years of experience in cGMP biologics or cell culture manufacturing (biotech/cell therapy manufacturing preferred).
Preferred Skills & Experience
- Aseptic gowning and manufacturing in an ISO 7 clean room environment.
- Cell counting on various platforms.
- Cell culture/expansion using bag systems and single-use large-scale bioreactors (Sartorius systems experience a plus).
- Lentiviral vector transduction.
- Cell harvesting and washing (automated and manual) (kSep experience a plus).
- Cell selection/depletion using Miltenyi CliniMACS Prodigy.
- Fill finish and cryopreservation processes/equipment in bags and vials (AT-vialing a plus).
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Working Conditions and Physical Requirements
- Work with human-origin cells/cell lines and viral vectors.
- Occasional weekend or evening work may be required.
Benefits (as listed)
- 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 year-end holiday week)
Compensation
- Base salary: $75,000–$105,000 (exact compensation varies by level, skills, and experience).
- The Manufacturing Associate will support manufacturing of Artiva’s off-the-shelf cell therapy platforms in a new cGMP facility. Develop and adhere to SOPs for GMP facility operations, equipment/facility monitoring, and internal manufacturing of cell therapies across multiple programs.
Duties/Responsibilities
- Assist in setting up cGMP manufacturing suites and equipment/fixtures as needed.
- Perform facility and equipment monitoring activities.
- Assist in authoring manufacturing SOPs and batch production records that comply with cGMP requirements.
- Perform cGMP manufacturing and support operations described in SOPs and batch records across multiple programs.
- Complete documentation required by process tech-transfer protocols, validation protocols, SOPs, and batch records (cGDP standards).
- Perform tasks consistent with safety policies, quality systems, and GMP requirements.
- Complete training assignments and qualifications for GMP manufacturing and related process technical skills.
Required Skills & Experience
- Bachelor’s degree in a relevant science or engineering discipline, or equivalent work experience.
- Minimum 2 years of experience in cGMP biologics or cell culture manufacturing (biotech/cell therapy manufacturing preferred).
Preferred Skills & Experience
- Aseptic gowning and manufacturing in an ISO 7 clean room environment.
- Cell counting on various platforms.
- Cell culture/expansion using bag systems and single-use large-scale bioreactors (Sartorius systems experience a plus).
- Lentiviral vector transduction.
- Cell harvesting and washing (automated and manual) (kSep experience a plus).
- Cell selection/depletion using Miltenyi CliniMACS Prodigy.
- Fill finish and cryopreservation processes/equipment in bags and vials (AT-vialing a plus).
- Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing.
Working Conditions and Physical Requirements
- Work with human-origin cells/cell lines and viral vectors.
- Occasional weekend or evening work may be required.
Benefits (as listed)
- 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 year-end holiday week)
Compensation
- Base salary: $75,000–$105,000 (exact compensation varies by level, skills, and experience).