Simplify Logo

Full-Time

Senior Manager

Quality Control, 24205-U-682-QC

Confirmed live in the last 24 hours

ArsenalBio

ArsenalBio

201-500 employees

Develops CRISPR-enabled solid tumor cell therapies

AI & Machine Learning
Data & Analytics

Compensation Overview

$144.7k - $177.2kAnnually

Expert

Stillwater, OK, USA

Category
Biology Lab & Research
Biology & Biotech
Required Skills
Data Analysis
Requirements
  • Bachelor’s degree in a relevant scientific field or discipline and 10+ years of experience in biotechnology/pharmaceutical industry, advanced degree preferred
  • 4+ years progressive management experience and proven leadership skills managing a quality control function
  • Strong knowledge of cGMP/ICH/FDA/EMA regulations
  • Prior experience in Quality/Analytics for cell therapy products
  • In-depth knowledge of QE principles, concepts, industry practices, and standards
  • Strong technical writing and verbal communication skills
  • Strong critical thinking and problem-solving skills
  • Ability to prioritize deliverables for the overall good of the project
  • Ability to work in cleanroom environments
Responsibilities
  • Establish QC strategy for the organization, including QC analytics for raw materials, in-process, and final product
  • Ensure timely and accurate release of Arsenal’s cell therapy drug products to support clinical manufacturing
  • Make sound decisions regarding complex technical issues and communicate decisions effectively with internal stakeholders, elevating complex issues as appropriate
  • Providing and receiving feedback to support the growth and development of team members
  • Provide support for deviations, OOS, change control, investigations, and CAPA
  • Provide support during inspections/audits as a QC subject matter expert
  • Provide support with regulatory submissions (IND/BLA)
  • Establish team priorities to meet overall project targets and timelines
  • Manage employees, contractors and/or consultants, as needed
  • Provide additional support to other functions, including Quality Operations and QMS, as requested by management, to support project milestones
  • Promote continuous improvement using Lean and Six Sigma principles

Arsenal Bio specializes in developing solid tumor cell therapy using precise CRISPR-enabled genome editing and integrated circuits with logic gates for improved tumor targeting. They also employ therapeutic enhancements for multiple pharmaceutical functions.

Company Stage

Series B

Total Funding

$525.8M

Headquarters

South San Francisco, California

Founded

2019

Growth & Insights
Headcount

6 month growth

0%

1 year growth

-1%

2 year growth

30%

Benefits

Medical, dental, & vision coverage

Virtual & telehealth options

Parental leave

Flexible work schedule

Flexible PTO

Mental health resources