Manager-Engineering & TQM
WestlakeSalary not specified
Full Time
Expert & Leadership (9+ years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
BiotechnologyIndustries
Requirements
- Bachelor's degree in a relevant field such as Biotechnology, Engineering, Manufacturing or Operations Management; advanced degree preferred
- 3-5 years of experience in manufacturing or operations optimization, preferably in a regulated environment (e.g., pharmaceuticals, medical devices, or biotechnology)
- Required: Lean certification (minimally green belt certified) – Including demonstrated experience applying Lean, Six Sigma, and other operational excellence methodologies to manufacturing operations
- Experience with data analysis, process optimization, and implementation of KPIs and performance metrics
- Understanding of cell therapy manufacturing processes, regulatory requirements (GxP, GMP, FDA, EMA), or related industry standards
- Proficient in data analysis tools (Excel, Minitab, etc.), statistical process control (SPC), and process modeling techniques
- Strong understanding of Lean, Six Sigma, and other continuous improvement methodologies, certification a plus
- Excellent analytical, problem-solving, and troubleshooting skills
Responsibilities
- Manufacturing Process Optimization: Lead and implement continuous improvement initiatives aimed at optimizing manufacturing processes. Use Lean, Six Sigma, and other operational excellence tools to streamline production workflows, reduce waste, and increase overall efficiency
- Metrics Development & Monitoring: Define, implement, and monitor key performance indicators (KPIs) that track the efficiency, quality, and effectiveness of manufacturing operations. Develop dashboards and reporting tools to ensure real-time visibility into process performance
- Data Analysis & Reporting: Collect and analyze data related to production metrics, production performance, cycle times, etc. Identify trends and areas of improvement and use data to drive decision-making for process enhancements
- Cross-Functional Collaboration: Work closely with operations, engineering, quality, and supply chain teams to understand challenges, identify bottlenecks, and optimize processes across departments. Facilitate communication between teams to ensure alignment on improvement initiatives
- Project Management: Lead projects aimed at improving manufacturing processes and performance. Manage project timelines, budgets, and resources to ensure successful completion
- Compliance & Quality Assurance: Ensure all manufacturing optimization activities comply with industry standards and regulations (e.g., GMP, ISO). Work closely with the quality team to ensure that improvements maintain or enhance product quality and safety
- Continuous Improvement Culture: Foster a culture of continuous improvement within the organization, encouraging employees to contribute ideas, solve problems, and implement solutions that drive operational excellence
Skills
Lean
Six Sigma
Continuous Improvement
KPIs
Data Analysis
Dashboards
Reporting
Process Optimization
Manufacturing Processes
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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