Full-Time

Associate Director

CMC Process Development and Characterization

Posted on 8/21/2024

Orca Bio

Orca Bio

51-200 employees

Develops and commercializes cell therapies

Biotechnology
Healthcare

Compensation Overview

$170k - $205kAnnually

Senior, Expert

Menlo Park, CA, USA

Onsite position in Menlo Park, CA.

Category
Public Health
Biology Lab & Research
Biology & Biotech
Requirements
  • PhD in Pharmaceutical Sciences, Biology, Immunology, Cell Biology, with at least 8 years relevant industry experience. Candidates with B.S./M.S. may also be considered with demonstrated leadership track record in process development and validation
  • Knowledge and broad understanding of process development principles associated with a GMP drug product manufacturing site. Good understanding of relevant ICH guidelines
  • Experience working with contract service providers and consultant contributors externally to complete project assignments
  • Experience in GMP cell therapy and/or biological product manufacturing, preferably with emphasis on cell therapy and individualized patient therapies is a plus
  • Experience working with and leading cross functional teams such as CMC, Quality and Regulatory
  • Outstanding written and verbal communication skills, self-starter with great interpersonal skills and strong planning/tracking skills
  • Must be able to work in a fast paced, changing environment with demonstrated ability to manage multiple competing responsibilities with a high degree of self-motivation
Responsibilities
  • Manage and develop strategic direction for process development and process characterization activities within the CMC function.
  • Manage and influence strategy for the development and monitoring of critical process controls and continued process verifications.
  • Manages, tracks and reports on readiness/execution status for all development activities and deliverables.
  • Generates documents (plans, protocols, reports) according to timelines and commitments.
  • Manage and mentor career development of cell therapy scientists; organize resourcing of projects and project assignments of group members.
  • Author and review protocols, technical reports, method SOPs and/or work instructions.
  • Responsible for all appropriate documentation for regulatory submissions.
  • Collaborate with and provide training and guidance to process validation and CMC group members in defining, executing and analyzing studies.
  • Prepare and present high-quality data summaries and project progress updates to stakeholders and at cross-functional team meetings.

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.

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