The role involves providing technical leadership to develop first-class patient-centric biologic/device combination products including prefilled syringes and autoinjectors
Job Summary
The role involves providing technical leadership to develop first-class patient-centric biologic/device combination products including prefilled syringes and autoinjectors.
Candidates must have hands-on experience developing user requirements, establishing statistical acceptance criteria, and executing test method validation for combination products.
The company offers a competitive compensation package including base salary, performance bonus, equity grants, and three weeks of PTO.
Matching Summary
The role involves providing technical leadership to develop first-class patient-centric biologic/device combination products including prefilled syringes and autoinjectors.
Salary
Base: $180,000 - $200,000; Bonus/Equity: Performance bonus and equity grant opportunities; Benefits: Health, welfare, retirement benefits, three weeks PTO
Skills & Requirements
Must-have
10+ years industry experience
Biologic/device combination products
Prefilled syringe with needle safety device
Autoinjector or on-body injector
Design and Development Verification plans
Test Method Validation
ISO 14971 risk management
Nice-to-have
Advanced degree preferred
Late phase clinical development experience
Commercialization of combination products
Root cause analysis expertise
Cross-functional collaboration skills
C.O.R.E. values alignment
Key Requirements
Minimum 10 years relevant industry experience
BS in mechanical, biomedical, or chemical engineering
Experience with 21 CFR Part 820 and ISO 13485
Ability to travel up to 25% domestically and internationally