Manager, Device Development & Manufacturing

Scorpion Therapeutics; United States; Hybrid; USD 110,000 - 170,000; Full time

Job summary

Scorpion Therapeutics is seeking a role focused on the development and manufacturing of injectable drug delivery devices, including prefilled syringes and autoinjectors. You will oversee vendor selection, support from technology choice through clinical trials to commercialization, and ensure regulatory compliance.

The position emphasizes leading verification/validation activities and cross-team collaboration on device specs, risk assessments, and process validation.

Qualifications

• 6+ years in process or product engineering, preferably within medical devices or pharmaceutical manufacturing.
• Experience with combination products and ISO 13485.
• Knowledge of 21 CFR Part 4 regulations.

Responsibilities

• Oversee vendor selection.
• Support development from technology choice through clinical trials to commercialization.
• Ensure regulatory compliance.
• Lead design verification and validation activities.
• Collaborate across teams on device specifications, risk assessments, and process validation.

Skills

Process engineering

Product engineering

Medical devices

Education

BS/BA in engineering or life sciences

Job description

Role

Manage the development and manufacturing of injectable drug delivery devices within biopharma, focusing on technologies like prefilled syringes and autoinjectors.

Responsibilities

oversee vendor selection, support development from technology choice through clinical trials to commercialization, ensure regulatory compliance, lead design verification and validation activities, and collaborate across teams on device specifications, risk assessments, and process validation.

Qualifications

6+ years in process or product engineering, preferably within medical devices or pharmaceutical manufacturing; BS/BA in engineering or life sciences, with experience in combination products and knowledge of standards such as ISO 13485 and regulations like 21 CFR Part 4.

High-Value

expertise in device design and development, regulatory compliance for combination products, experience with human factors assessments, and familiarity with emerging autoinjector technologies.

Work Setup

hybrid or remote based in Waltham, MA, with up to 15% travel.