Operations Manager
Dandy$116,500 - $137,000/year
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
- Visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment
- Ability to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods; no cosmetics (makeup, painted nails), jewelry, or facial piercings in the cleanroom; disclose any skin conditions that cause shedding
- Ability to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs
- Comfortable regularly participating in video-based meetings
- Availability to work scheduled overtime, weekends, or holidays based on business needs
Responsibilities
- 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
- Collaborate with cross-functional teams (Manufacturing, Quality, Facilities, Materials Management, MSAT, IT) to implement innovative solutions in accordance with GMP and regulatory requirements
- Support logistics management for the delivery of starting materials from donors and drug product shipments to customers
- Ensure documentation and preparations are in place 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., Credo conditioning, sample drop-offs, and sample requests)
- Establish and optimize manufacturing workflows to ensure effective use of labor, smooth integration with analytical testing, and timely delivery of clinical products to patients
- Collaborate closely with the logistics team to support the execution of patient batch orders, scheduling of routine non-patient operations, maintenance activities, and project work
- Support capacity planning and production ramp-up initiatives to meet growing clinical demand at the clinical manufacturing facility
Skills
Manufacturing
Logistics
Capacity Planning
Production Scheduling
Workflow Optimization
Cross-functional Collaboration
Quality
Facilities Management
Materials Management
MSAT
Orca Bio
Develops and commercializes cell therapies
About Orca Bio
Orca Bio operates in the biotechnology sector, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company works to enhance these therapies, aiming to make them safer and more effective for patients. Orca Bio's products are primarily used by healthcare providers who administer these therapies to patients as part of their treatment plans. Unlike many competitors, Orca Bio emphasizes a strong team culture and values communication with stakeholders, keeping them informed about the company's progress and developments. The goal of Orca Bio is to improve patient outcomes through advanced cell therapies, addressing conditions that currently have limited treatment options.
Menlo Park, CaliforniaHeadquarters
2016Year Founded
$186.8MTotal Funding
SERIES_DCompany Stage
Biotechnology, HealthcareIndustries
51-200Employees
Benefits
Health Insurance
Dental Insurance
Vision Insurance
Life Insurance
Unlimited Paid Time Off
401(k) Retirement Plan
Parental Leave
Risks
Emerging competition from BlueRock Therapeutics in stem cell therapies.
Aspen Neuroscience's advancements in personalized stem cell therapies pose a threat.
Competitors' focus on iPSC-derived therapies may overshadow Orca Bio's offerings.
Differentiation
Orca Bio focuses on high-precision cell therapies for cancer and autoimmune diseases.
Their lead product, Orca-T, shows promising relapse-free survival rates in clinical trials.
Orca Bio's therapies aim to replace diseased blood and immune systems with healthy ones.
Upsides
Orca-T demonstrated 87% relapse-free survival in a Phase 1b/2 trial.
FDA's expedited approval pathways could accelerate Orca Bio's market entry.
Advancements in gene editing enhance the efficacy of Orca Bio's cell therapies.
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