Associate Director, CMC Drug Product
Company
Recursion
Location
York ON
Type
Full Time
Job Description
Recursion is the 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.Â
We care about our drug candidates, our Recursionauts, their families, each other, the communities in which we live and work, and we care deeply about the patients we aim to serve and their loved ones. We also care about our work; we operate with an owner’s mindset. We care so much that we are willing to do and say the hard things to make each other and the company better
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The Impact You’ll Make
Recursion is at the forefront of reimagining drug discovery through the integration of automated cell biology, high-dimensional and diverse data sets, and sophisticated analytics. We are seeking an Associate Director, CMC Drug Product to develop and oversee the manufacture of medicines that are in current clinical trials and the future medicines that will be advanced into candidate nomination. In this role, you will:Â
- Lead external drug product development across select portfolio candidates including oversight of CDMOs and strategic technical development relationshipsÂ
- Provide technical authoring of internal reports and regulatory filings supporting Recursion’s clinical programs Â
- Ensure delivery of formulated drug product from external manufacturing campaigns adhering to current quality guidelines and delivery timelines  Â
- Critically analyze development, manufacturing, and analytical data and batch records to identify and resolve formulation challenges during drug product developmentÂ
- Participate in developing and extending our CDMO relationships for drug product expenditures and achieving our quality requirementsÂ
The Team You’ll JoinÂ
As CMC Drug Product Associate Director, you will be an essential member of the Recursion CMC Team reporting to the Director of Drug Product Development. The CMC Team is an empowered, execution-minded group of scientists and technical experts responsible for translating Recursion’s innovative science to patients in the clinic through CMC activities and deliverables.Â
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 experienceÂ
- Knowledge of and experience in oral solid dose formulation development and manufacturing particularly across Phase I to Proof of Concept Â
- Experience leading external development and CDMO relationships is a plusÂ
- Cross-functional understanding related to formulation development including pre-formulation, solid state, analytical results, stability trending, quality and regulatory affairsÂ
- Well-versed with the latest trends in drug formulation technologies and the outsourcing industry
- Demonstrated track record in the areas of drug product development (authoring of CTD sections) with prior IND/IMPD authoring experience preferredÂ
- Ability to travel to external manufacturing sites 10-20% of the time
#LI-LM1
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.Â
- 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.
More About RecursionÂ
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.Â
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.Â
Date Posted
12/12/2022
Views
6
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