CMC Drug Product Associate Director/Sr. Manager

Employer
Recursion
Location
Salt Lake City, Utah, United States
Posted
Jan 22, 2022
Ref
3771510
Required Education
Doctorate/PHD/MD
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

  • Lead the drug product development for assigned programs
  • Provide technical leadership, project management and oversight of formulation development and manufacturing activities supporting Recursion’s clinical programs 
  • Ensure delivery of formulated drug product from external manufacturing campaigns adhering to current quality guidelines.  Typical travel to external manufacturing sites can be around 10-20% of the time.
  • Critically analyze development, manufacturing, and analytical data to identify and resolve formulation challenges during drug product development
  • Participate in budget planning and forecasting for drug product expenditures and ensure budget, schedules, and performance requirements are met

 

The Team You’ll Join 

As CMC Drug Product Associate Director, you will be an essential member of the Recursion Development Team reporting to the Director of Drug Product Development. The Development Team is an empowered, execution-minded group of business development and clinical development professionals responsible for translating Recursion’s innovative science to patients through clinical and business development activities.

 

The Experience You’ll Need

  • Ph.D. in pharmaceutical sciences, chemical engineering, or closely related field with a minimum of 5-8 years’ experience or M.S. with 8-12 years of experience. 
  • Strong knowledge of & experiences in oral solid dose formulation development and manufacturing particularly across Phase II/Phase III stages and general knowledge across all phases of drug development, from identified lead to Phase I dosing and to process validation and launch.
  • Phase II/Phase III development experience is required
  • Experience in continuous drug product manufacturing is a plus
  • Demonstration of cross-functional understanding related to formulation development including pre-formulation, analytical results, stability trending, quality and regulatory affairs
  • Well-versed with the latest trends in drug formulation technologies and the outsourcing industry
  • Excellent verbal and communication skillsDemonstrated track record in the areas of drug product development (authoring of CTD sections) with prior NDA/MAA preferred.

#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.