The Next Frontier of Medicines for Cardioendocrine Diseases. Backed by Third Rock Ventures.
About the role
This is a key role within our Technical Operations team as we aggressively advance our two lead assets into mid- and late-stage clinical development. Both assets include a transition from vial to prefilled drug delivery devices with a subcutaneous route of administration. Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Serve as Marea’s technical lead for combination product development of these programs, owning the design and development files for all product configurations
- Lead device risk management to ISO 14971:2019, including the use-related risk analysis, design FMEA, and process risk assessments with partners
- Work with human factors specialists to plan formative and summative studies to IEC 62366-1:2015 and FDA human factors guidance, and carry the findings into design, labeling, and the instructions for use
- Support selection and technical oversight of the clinical assembly and packaging CMO, including design transfer, assembly process development, equipment qualification, and on-site support during clinical builds
- Lead primary and secondary packaging development, covering container closure integrity strategy and testing as well as shipping and distribution simulation testing
- Define the device portion of combination product stability and shelf-life studies with the Drug Product and Analytical teams
More about this role
Marea Therapeutics is a clinical-stage biotechnology company based in South San Francisco with a growing pipeline of first-in-class therapies to address genetically validated cardioendocrine disease targets. Our therapies have the potential to serve as transformative treatment options for significant patient populations living with cardioendocrine diseases.
The company’s lead program, MAR001, is being developed for the treatment of severe hypertriglyceridemia (sHTG), a condition characterized by very high triglyceride levels and elevated risk of acute pancreatitis. Preclinical models with MAR001 demonstrated reduction in triglycerides, remnant cholesterol and ectopic fat, and improved insulin sensitivity. MAR001 has demonstrated strong and a differentiated profile in patients and is approaching Phase 3 development. Our second clinical asset, MAR002, is a monoclonal antibody targeting excess growth hormone produced by the pituitary gland in the rare hormonal disorder, acromegaly. MAR002 has potential to become best-in-disease and is quickly progressing into Phase 2/3 clinical development. We also have a third asset that is swiftly advancing through research discovery, with DC...
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