Job Title: Associate Engineer, Drug Implants and Devices
Location: Bethlehem, PA
At Agno Pharma, we provide a rewarding and challenging work environment. As a leader in the pharmaceutical CDMO space, we help our clients create products that save and improve lives.
Position Summary
We are seeking a highly motivated Drug Implant and Devices Associate Engineer, to assist in driving the development of novel drug-device combination products, including implants and controlled-release systems. The successful candidate will work with senior engineers to design and evaluate drug-polymer formulations, develop implant or device manufacturing processes (e.g., coating, extrusion etc.), and support manufacturing of clinical supplies and commercial products.
Key Responsibilities
· Product Development: Working under the supervision of senior colleagues, contribute to formulation and manufacturing process development efforts for long-acting drug implants, devices, and extrusion or coating technologies for medical devices.
· Experimental Design: Apply Design of Experiments and Quality by Design principles to optimize drug loading, release kinetics, and stability.
· Drug-Device Integration: Integrate drug product and delivery devices and ensure functionality
· GMP Compliance: Author GMP manufacturing batch records, SOPs, and development reports to support regulatory filings
· Tech Transfer and Scale-Up: Collaborate with cross-functional teams to assist in the transfer and scale up manufacturing from lab-scale to commercial manufacturing
Required Qualifications
Education: BS or MS in Biomedical Engineering, Pharmaceutical Science, Chemical Engineering, Mechanical Engineering or related field.
- Experience: 0 – 3 years related experience in the medical device or pharmaceutical industry, or equivalent combination of education and experience working under current Good Manufacturing Practices (cGMP). Previous experience in drug product formulation and characterization is preferred.
- Technical Skills: Background in polymer science, polymer engineering, and controlled release.
- Regulatory Knowledge: Familiarity with FDA/cGMP guidelines for combination products.
Preferred Qualifications
- Previous experience in drug product formulation and characterization is preferred.
- Experience with hot-melt extrusion, device design and manufacturing.
- Hands-on experience with in vitro dissolution modeling.
- Familiar with device Design Controls
Equal Opportunity Employer
Benefits:
- 401(k) matching
- Dental insurance
- Disability insurance
- Employee assistance program
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Work Location: In person
