Full-Time

Quality Assurance Senior Representative

Posted on 7/18/2024

Orca Bio

Orca Bio

51-200 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Compensation Overview

$100k - $150kAnnually

Senior, Expert

Menlo Park, CA, USA

This position requires onsite presence in Menlo Park, CA.

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 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.

Company Stage

Series D

Total Funding

$186.8M

Headquarters

Menlo Park, California

Founded

2016

Growth & Insights
Headcount

6 month growth

-1%

1 year growth

-4%

2 year growth

-2%
Simplify Jobs

Simplify's Take

What believers are saying

  • 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.

What critics are saying

  • 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.

What makes Orca Bio unique

  • 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.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Unlimited Paid Time Off

401(k) Retirement Plan

Parental Leave

INACTIVE