Director, Process Development mRNA

Employer
Providence Therapeutics Holdings, Inc.
Location
Calgary (City), Alberta
Posted
Apr 07, 2021
Required Education
Doctorate/PHD/MD
Position Type
Full time

Providence Therapeutics is a clinical stage biotechnology company that develops mRNA vaccines for human use. 

We are a Canadian company with operations in Calgary, AB and Toronto, ON.

Our mission is to provide safe and effective medicines for people suffering from diseases with unmet medical needs. At Providence, the patient is always the priority. Our lead program is a personalized mRNA-based vaccine against cancer. Using advanced technology, we identify a patient's tumor mutations and develop a therapeutic vaccine that will elicit an immune response against the tumor cells.

Providence Therapeutics is seeking a Director of Process Development for mRNA manufacturing.  We are looking for an individual that shares our passion for finding cures for patients with unmet medical needs and looking for solutions to the Covid-19 pandemic. This individual will be responsible for leading the process from development of clinical and commercial manufacturing processes for mRNA drug substances to oversight of external manufacturing, ensuring that the mRNA product for clinical trials meets quality targets and regulatory requirements. They will be a process genius that can identify and implement solutions to address technical challenges in manufacturing and support manufacturing needs.

The successful candidate will have a PhD in a relevant discipline, such as chemical engineering, biomolecular engineering, or biotechnology, along with a minimum of ten years relevant industrial experience with, including direct experience with biologics or oligonucleotide process development. They will have a demonstrated track record with process development relating to both early and late-stage drug substances or products. The Director, Process Development will have experience with technology transfer to CDMOs, and external manufacturing oversight. The successful candidate will be familiar with mRNA characterization methods, authoring CMC sections of regulatory documents, and a strong working knowledge of cGMP and quality systems requirements. They will be a subject matter expert when it comes to preparative chromatographic purification, UFDF, and molecular biology. The successful candidate will be a highly collaborative individual, with strong leadership skills, and the motivation and passion to find cures and solutions for patients.

For more information or to apply for this position, please submit your application and related materials and state the title of the position in the subject line of your email.

We thank all applicants for their interest, however only those under consideration for the role will be contacted.