RTP North Carolina
Satsuma Pharmaceuticals is a clinical stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine. Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device. Satsuma has recently secured $62M from investors, which will fund the STS101 Phase 3 development program.
This newly developed Device Process Engineer/Managerrole will report to the Head of Manufacturing and oversee all aspects of the work of the external device supplier. This includes development of injection molding/blow molding process at the supplier to meet the product requirements in preparation for commercialization. The role will work with the current supplier of the device to develop and ensure a robust supply chain. The roll will also require some device design engineering.
Duties and Responsibilities:
- Responsible for the development of the device manufacturing strategy to ensure a secure supply chain for development and commercial products.
- Develop risk mitigation strategy and plan for device supply chain for a drug-device combination product, as well as the execution
- Work to reduce cost of goods of device components.
- Responsible for the technical aspects of the quality agreements for device supply working with the Quality Director.
- Responsible for technical aspects of our supply agreements, working closely with the supply chain manager.
- Responsible for device design engineering tasks and/or outsourcing of them.
Minimum Requirements Education/Experience:
- Bachelor of Science in Mechanical Engineering,Process Engineering, Material Science a closely related field.
- Minimum of 5 years’ experience in controlling injection and blow molding process for medical devices in drug-device combination products.
- Minimum of 3 years’ experience in the development of regulated medical devices design under Design Control (21 CFR 820) and ISO 14971; 2D/3D CAD expertise.
- Have a proven track record of delivering projects on time within budget.
- Excellent communication skills with an ability to work in cross-functional teams, including across multiple sites.
- Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted –delivers on promises, goals and expectations.
- Executes combination product development projects on time, in scope, and within budget with responsibilities in project leadership, technical product engineering, design transfer, and secondary packaging.
- Works closely with the cross-functional team to assure project success.
- Ensures that products being developed both internally and externally are technically robust through engineering analysis, ensuring that products perform sufficiently and reliably.
- Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions.
- Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards.
- Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments.
- Makes quality decisions with limited supervision.
For additional information:
Please send your resume or CV to us at firstname.lastname@example.org