Senior Scientist, Laboratory QA
Immunovant
Operations and Logistics Support Manager
Orca
full-time
Posted on:
Location Type: Office
Location: Sacramento • California • 🇺🇸 United States
Visit company websiteSalary
💰 $95,000 - $125,000 per year
Job Level
Mid-LevelSenior
Tech Stack
ERP
About the role
- Coordinate and enable seamless collaboration across Manufacturing, Quality, Facilities, Materials Management, MSAT, and IT to support clinical manufacturing operations
- Assess manufacturing processes in alignment with QC testing workflows to optimize execution from blood intake through patient delivery and product release
- Develop SOPs and procedures to support efficient and compliant production processes
- Support logistics management for delivery of starting materials from donors and drug product shipments to customers
- Ensure documentation and preparations for blood and graft pickups and deliveries
- Oversee timely completion of post-run closeout documentation, including upload of data files, temperature reports, and Bill of Materials, for QA review
- Execute cold storage practices and cryopreservation of drug products as needed
- Assist QA in tracking and reporting metrics such as cycle times and production efficiency
- Schedule and send logistics-related calendar invites (e.g., conditioning, sample drop-offs, and sample requests) to relevant teams
- Contribute to special projects focused on innovation and development of upcoming Orca products
- Update and implement SOPs and batch records as needed to reflect process improvements and operational changes
- Support capacity planning and production ramp-up initiatives to meet growing clinical demand at the Sacramento facility
Requirements
- Bachelor’s degree in life sciences, engineering, supply chain, operations management, or a related field
- Minimum of 3 years of experience in a GMP-regulated clinical manufacturing, logistics, or operations environment
- Working knowledge of GMP regulations, clinical production workflows, and compliance expectations
- Proven ability to work cross-functionally with Manufacturing, Quality, Logistics, and other technical functions
- Experience with logistics coordination, including managing patient- and donor-specific schedules and deliveries
- Strong organizational skills with attention to detail and ability to handle multiple time-sensitive activities
- Proficiency with Microsoft Office Suite and experience using digital systems (e.g., document control, scheduling tools)
- (Preferred) Experience with cold chain logistics and cryopreservation of clinical drug products
- (Preferred) Familiarity with ERP systems, LIMS, or other enterprise digital tools used in manufacturing and logistics
- (Preferred) Prior involvement in SOP development, batch record review, and QA documentation closeout
- (Preferred) Experience supporting capacity planning or clinical production scale-up
- (Preferred) Demonstrated ability to contribute to process innovation or new product operations planning
- (Preferred) Strong understanding of clinical supply chain management and quality metrics (e.g., cycle time)
Benefits
- pre-IPO equity
- competitive medical, dental, and vision benefits
- flexible PTO
- 401(k) plan
- life and accidental death and disability coverage
- parental leave benefits
- free daily lunches and snacks at our on-site locations
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
GMP regulationsclinical production workflowslogistics coordinationSOP developmentbatch record reviewcryopreservationcapacity planningprocess innovationquality metricsproduction efficiency
Soft skills
organizational skillsattention to detailcross-functional collaborationability to handle multiple activitiescommunication skills
