Associate Director of CMC Quality Assurance (CMO/LTO)

Employer
Recursion
Location
Salt Lake City, Utah, United States
Posted
Jan 12, 2022
Ref
3810923
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

  • Build a world-class Quality System for lifecycle management (audits, qualification, agreements, etc.) of Contract Manufacturing Organizations (CMO) and Laboratory Testing Organizations (LTO). You’ll collaborate with Recursion API, Drug Product, and Analytical Development teams in identifying CMO and LTO to support clinical programs. Additionally, you’ll directly support the release of clinical trial materials manufactured and tested by external organizations.
  • Lead the creation, implementation, and execution of fit-for-purpose Quality System processes and procedures for CMO and LTO management. You’ll lead the creation of additional Quality System elements as programs advance through clinical trial phases.
  • Collaborate and Execute at Recursion to drive a quality-minded, innovative culture and identify next-generation, industry-leading technologies to support our development programs through management of CMO/LTOs and the release and delivery of investigational medicines.

The Team You’ll Join

  • Reporting to the Senior Director, Quality Assurance, you will join a rapidly growing Quality Assurance team at Recursion, which includes Preclinical QA, Clinical QA, CMC QA, and Quality Systems. As a member of CMC Quality Assurance, you will be focused on supporting and enabling Recursion’s CMC capabilities through deep collaboration across QA, CMC Operations, Contract Manufacturing Organizations, and Recursion.

The Experience You’ll Need

  • Bachelor’s Degree in a Life Sciences field and 8+ years of related pharmaceutical experience (e.g., CMO/LTO/ Quality Assurance/Quality System).
  • Experience in building and implementing risk-based and fit-for-purpose Quality Systems for various phases of clinical programs.
  • Proficient in review and approvals of manufacturing, testing, and packaging documentation/records for small molecule API manufacturing processes, solid oral drug product manufacturing, and finished goods packaging.
  • Proficient in planning and conducting manufacturing and laboratory audits.
  • Proficient in the creation and management of Quality Agreements.
  • Understanding of (early phase) clinical trials, a broad understanding of drug development and therapeutic area knowledge relevant to Recursion’s pipeline, and internal strategies/tactics and external trends.
  • Solid understanding of ICH, FDA and USP guidelines is essential, including the ability to apply the guidelines in context of the stage of pharmaceutical development for CMO and LTO requirements.
  • Demonstrated ability, ideally in a smaller company, to flex between setting strategic direction and jumping in to get the work done.

#LI-CP1

The Values That We Hope You Share:

  • We Care: We care about our drug candidates, our Recursionauts, their families, each other, our communities, the patients we aim to serve and their loved ones. We also care about our work.
  • We Learn: Learning from the diverse perspectives of our fellow Recursionauts, and from failure, is an essential part of how we make progress.
  • We Deliver: We are unapologetic that our expectations for delivery are extraordinarily high. There is urgency to our existence: we sprint at maximum engagement, making time and space to recover. 
  • Act Boldly with Integrity: No company changes the world or reinvents an industry without being bold. It must be balanced; not by timidity, but by doing the right thing even when no one is looking.
  • We are One Recursion: We operate with a 'company first, team second' mentality. Our success comes from working as one interdisciplinary team.

Recursion spends time and energy connecting every aspect of work to these values. They aren’t static, but regularly discussed and questioned because we make decisions rooted in those values in our day-to-day work. You can read more about our values and how we live them every day here.

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

Recursion requires all employees to be fully vaccinated for COVID-19 prior to their first date of employment.

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.