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. STS101 is currently being evaluated in a Phase 3 clinical trial.
This newly developed Device Process Engineer/Manager role will report to the Head of Manufacturing and oversee all aspects of the work of the external device suppliers to ensure a robust supply chain. This includes development of injection molding/blow molding processes at suppliers to meet the product requirements in preparation for commercialization. The role will also require some device design and 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 and implement risk mitigation strategy and plan for device supply chain for a drug-device combination product.
- Work to reduce cost of goods of device components.
- Working closely with our Quality Director, establish quality agreements for device supply. Responsible for technical aspects of these agreements.
- Working closely with our Supply Chain Manager, establish supply agreements. Responsible for technical aspects of these agreements.
- Responsible for device design and engineering tasks and/or outsourcing of them, with oversight of any outsourced work.
- Responsible for STS101 design control.
Minimum Requirements Education/Experience:
- Bachelor of Science in Mechanical Engineering, Process Engineering, Material Science or 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 5 years’ experience in the development of medical devices under Design Control (21 CFR 820) and ISO 13485; 2D/3D CAD expertise.
- Minimum of 5 years’ experience on risk management per ISO 14971 and ICH Q9.
- Minimum of 3 years’ experience in managing suppliers.
- 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. Assume project leadership role with responsibility for technical product engineering, design transfer, and secondary packaging.
- Works closely with the cross-functional team to assure project success.
- Performs engineering analyses to ensure that products being developed (both internally and externally) are technically robust with reliable and sufficient performance.
- 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