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Full-Time

Quality Assurance Senior Representative

Confirmed live in the last 24 hours

Orca Bio

Orca Bio

51-200 employees

Develops and commercializes cell therapies

Hardware
Biotechnology

Compensation Overview

$100k - $150kAnnually

Senior, Expert

Menlo Park, CA, USA

Category
QA & Testing
Quality Assurance
Requirements
  • Proven experience (5+ years) in quality assurance, ideally within clinical-stage manufacturing for a biotech company.
  • Familiarity with antibody manufacturing is highly desirable.
  • Strong self-motivation and ability to work with minimal oversight.
  • Excellent communication skills to work effectively with cross-functional teams.
Responsibilities
  • As an on-site team of one, oversee the quality assurance activities at the Menlo Park site.
  • Conduct batch releases and manage quality control testing.
  • Ensure compliance with clinical stage manufacturing requirements, with a preference for experience in antibody or large molecule manufacturing.
  • Work closely with manufacturing, CMC and science teams on quality assurance tasks.
  • Participate in tech transfer from clinical production to commercial production within the next 1-2 years.
  • Collaborate with all staff to support consistent production at the Menlo Park site.
  • Implement and manage documentation and quality control procedures, updating obsolete procedures as necessary.
  • Contribute to the development of in-house raw material production, ensuring the facility meets regulatory and quality standards.
  • Contribute to the setup and management of a quality system for pipeline products, ensuring high standards for clinical manufacturing.

Orca Bio operates in the biotechnology field, specifically focusing on cell therapies that utilize the body's own cells to treat diseases. The company aims to enhance these therapies to make them safer and more effective, ultimately improving patient outcomes. Orca Bio's products are designed for 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 significantly impact healthcare by advancing cell therapy treatments for conditions that currently have limited options.

Company Stage

Series D

Total Funding

$375M

Headquarters

Menlo Park, California

Founded

2016

Growth & Insights
Headcount

6 month growth

8%

1 year growth

14%

2 year growth

35%
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Simplify's Take

What believers are saying

  • Orca Bio's promising clinical data, including high relapse-free survival rates, highlight the potential for curative treatments in challenging patient groups.
  • The company's participation in prestigious conferences like the J.P. Morgan Healthcare Conference and the American Society of Hematology Annual Meeting underscores its industry recognition and thought leadership.
  • Orca Bio's strong team culture and commitment to employee value make it an attractive workplace for talented individuals in the biotechnology field.

What critics are saying

  • The competitive landscape in cell therapy and biotechnology requires continuous innovation to maintain a leading position.
  • Clinical trials and regulatory approvals are inherently risky and can lead to delays or failures, impacting the company's progress and financial stability.

What makes Orca Bio unique

  • Orca Bio's focus on high-precision cell therapies for cancer, autoimmune diseases, and genetic blood disorders sets it apart in the biotechnology sector.
  • Their proprietary single-cell precision manufacturing platform offers uniquely-defined products that aim to transform allogeneic cell therapy.
  • Orca Bio's investigational therapies, such as Orca-T and Orca-Q, demonstrate significantly better outcomes with fewer risks compared to standard treatments.