Associate Director, CMC Quality Assurance External Manufacturing

Employer
Recursion
Location
Salt Lake City, Utah, United States
Posted
Nov 25, 2021
Ref
3603160
Required Education
Bachelors Degree
Position Type
Full time

Recursion is a clinical-stage biotechnology company decoding biology by integrating technological innovations across biology, chemistry, automation, data science and engineering to radically improve the lives of patients and industrialize drug discovery. Our team is working to solve some of the hardest, most meaningful problems facing human health today. Come join us in our mission to decode biology to radically improve lives, while doing the most impactful work of your life.

The Impact You’ll Make

  • Builds a CMC Quality Operations program in support of GMP manufacturing, testing, and release activities, including leadership of the Material Review Board; change control review and approval; deviations and OOS review and approval; regulatory/IND impact assessments; and batch record review and release.
  • Influences collaborative and successful partnerships with CDMOs and other Vendors by implementing risk-based vendor qualification and governance practices, including strategic alignment, Quality Agreements; qualification evaluations and audits; and performance indicators (KPIs/KQIs).
  • Partners with team members to drive quality initiatives and continuous improvement, in support of an effective Quality Management System and high-quality outcomes across the development organization.

 

The Team You’ll Join 

While reporting to the Sr Director of QA, you will be joining a growing Quality Assurance team at Recursion, where you will partner closely with the Development and CMC teams to assure the phase-appropriate and quality development and manufacture of drugs in support of our rapidly-expanding clinical programs. You will bring your Quality expertise and mindset to act with urgency and agility to help build a next-generation biopharmaceutical company.

 

The Experience You’ll Need

  • 8+ years in a GMP environment with comprehensive and practical expertise in cGMPs, Health Authority Regulations, and Quality Systems 
  • CMC Operations experience preferred with sound technical knowledge of Drug Substance, Drug Product, and Finished Goods manufacturing processes for clinical-stage products
  • Demonstrated leadership in using creative and agile approaches to continuously improve Quality System processes and drive results
  • Ability to manage risks and execute against strategic and tactical objectives
  • Ability to work cross functionally

 

#LI-CP1

The Benefits/Perks You’ll Enjoy as a Full-Time Employee at Recursion: 

  • 100% Coverage of health, vision, and dental insurance premiums 
  • 401(k) with generous matching (immediate vesting)
  • Stock option, restricted stock unit (RSUs) and employee stock purchase plan (ESPP) programs
  • Two one-week paid company closures (summer and winter) 
  • Flexible vacation/sick leave
  • Generous paid parental leave (including adoptive)
  • Onsite daycare facility** (Salt Lake City)
  • Commuter benefit and vehicle parking to ease your commute** 
  • Complimentary chef-prepared lunches and well-stocked snack bars** (Salt Lake City)
  • Monthly fitness/wellness stipend 
  • One-of-a-kind 100,000 square foot headquarters complete with a 70-foot climbing wall, showers, lockers, and bike parking** (Salt Lake City)

**United States based employees

More About Us 

Central to our mission is the Recursion Operating System, or Recursion OS, that combines an advanced infrastructure layer to generate what we believe is one of the world’s largest and fastest-growing proprietary biological and chemical datasets and the Recursion Map, a suite of custom software, algorithms, and machine learning tools that we use to explore foundational biology unconstrained by human bias and navigate to new biological insights which may accelerate our programs. We are a biotechnology company scaling more like a technology company. Recursion is proudly headquartered in Salt Lake City. 

Learn more at www.recursion.com, or connect on Twitter and LinkedIn.

Recursion is an Equal Opportunity Employer that values diversity and inclusion.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected under applicable federal, state, local, or provincial human rights legislation.