Pigment Systems Administrator
Huntress$140,000 - $150,000/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
- 5+ years of experience with a Quality Control background in a regulated industry, such as antibodies, proteins, and reagent testing or pharmaceutical manufacturing
- 3+ years of experience administering enterprise systems (e.g., LIMS) in a GMP regulated environment
- Hands-on experience with enterprise level system administration in a GMP regulated environment
- Strong problem-solving skills
- Ability to collaborate with cross-functional teams including IT, Quality, and Laboratory Operations
- Visual acuity of 20/20 (corrected or uncorrected) and normal color vision
- Ability to meet cleanroom gowning requirements, including wearing full gowning for extended periods
- No use of cosmetics, jewelry, or facial piercings in cleanroom; disclose any skin conditions causing shedding
- Ability to work at Orca Bio Sacramento locations (3400 Business Dr. or 7910 Metro Air Pkwy) based on needs
- Comfortable participating in video-based meetings
- Availability to work scheduled overtime, weekends, or holidays based on business needs
Responsibilities
- Support the implementation and validation of a new LIMS system including requirements gathering, configuration, and testing
- Assist with configuration and administration of enterprise systems (e.g., MasterControl, electronic quality systems)
- Perform day-to-day administration for enterprise systems including user account provisioning, role/permission management, and system configuration changes
- Conduct periodic system and audit trail reviews to ensure compliance with 21 CFR Part 11, GxP regulations (including GMP), and internal policies
- Monitor system performance and troubleshoot issues
- Support internal and external audits as needed for enterprise systems
- Provide frontline support and assistance to LIMS end users
- Implement new modules for various enterprise systems to shape design, configurations, and workflows
- Support testing for enterprise systems including preparing test plans and evaluating test results for implementations, modifications, or upgrades
Skills
LIMS
System Administration
GMP
MasterControl
Electronic Quality Systems
Data Integrity
Regulatory Compliance
Enterprise Systems
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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