CMC Quality – Qualified Person (Contractor)
- Employer
- Recursion
- Location
- Remote Opportunity
- Start date
- Nov 11, 2024
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- Discipline
- Quality, Quality Control, Science/R&D, CMC
- Required Education
- Bachelors Degree
- Position Type
- Contract
Job Details
The Impact You’ll Make
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. This role will be instrumental in ensuring that clinical trials associated with Recursion programs are able to expand into any region in the world!
- Create world-class internal infrastructure to enable certification of materials for use in EU and UK clinical trials. You’ll collaborate with other members of Quality, Manufacturing, Process Development, and Analytical Development to build and implement this capability.
- Lead the implementation of fit-for-purpose quality systems and processes enabling the expansion of clinical trials beyond the United States into the EU and UK. As other regions are identified (e.g. Israel, Canada, etc.) you will lead the CMC Quality effort to enable the supply of materials into the clinic. Regulations provide the framework; you will bring innovation and creative thinking into the mix!
- Partner across Recursion to drive a quality-minded, innovative culture and identify next-generation, industry-leading technologies to support our development programs through the delivery of investigational medicines.
Location:
This position is fully remote, however, if the candidate is located near our London office, they are highly encouraged to work from that location at least 3 business days per week.
The Team You’ll Join
Reporting to the Senior Director, Quality Strategy & Operations, you will be joining a rapidly growing Quality Assurance team at Recursion, which will include CMC QA, GCP QA, and GXP Quality Systems. As a member of CMC Quality, you will be focused on supporting and expanding Recursion’s CMC capabilities through deep collaboration across Quality, CMC Operations, and Recursion.
The Experience You’ll Need
- Degree in a relevant field (e.g. pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry and technology, or biology) and 6+ years of pharmaceutical CMC/ QA experience.
- Experience in building and implementing the infrastructure needed to support batch certifications for UK and EU use.
- Must be certified as a Qualified Person in the EU and UK.
- Hands on experience with small molecule API manufacturing processes, solid oral drug product manufacturing and finished goods packaging.
- Strong 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.
- Demonstrated ability, ideally in a smaller company, to flex between setting strategic direction and jumping in to get the work done.
- Ability to work 35-40 hours per week across multiple time zones.
#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.
More About Recursion
Recursion is a clinical stage TechBio company leading the space by decoding biology to industrialize drug discovery. Enabling its mission is the Recursion OS, a platform built across diverse technologies that continuously expands one of the world’s largest proprietary biological and chemical datasets. Recursion leverages sophisticated machine-learning algorithms to distill from its dataset a collection of trillions of searchable relationships across biology and chemistry unconstrained by human bias. By commanding massive experimental scale — up to millions of wet lab experiments weekly — and massive computational scale — owning and operating one of the most powerful supercomputers in the world, Recursion is uniting technology, biology and chemistry to advance the future of medicine.
Recursion is headquartered inSalt Lake City, where it is a founding member ofBioHive, the Utah life sciences industry collective. Recursion also has offices in London, Toronto, Montreal and the San Francisco Bay Area. Learn more atwww.Recursion.com, or connect onX(formerly Twitter) andLinkedIn.
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. Recursion welcomes and encourages applications from people with disabilities. Accommodations are available on request for candidates taking part in all aspects of the selection process.Recruitment & Staffing Agencies: Recursion Pharmaceuticals and its affiliate companies do not accept resumes from any source other than candidates. The submission of resumes by recruitment or staffing agencies to Recursion or its employees is strictly prohibited unless contacted directly by Recursion’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Recursion, and Recursion will not owe any referral or other fees. Our team will communicate directly with candidates who are not represented by an agent or intermediary unless otherwise agreed to prior to interviewing for the job.
Company
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.
Recursion is proudly headquartered in Salt Lake City, Utah with offices in Toronto, Montreal and Milpitas, California. We're working to solve some of the most meaningful problems facing human health today. Come do the most impactful work of your career at a company that prioritizes belonging, collaboration and career development.
- Website
- https://www.recursion.com/
- Phone
- 801-587-1629
- Location
-
41 S. Rio Grande Street
Salt Lake City
Utah
84101
United States
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