Product Development Engineer II, Intratumoral Drug Delivery

Continuity Biosciences, Inc.; Cary (NC); In loco; USD 80.000 - 120.000; Tempo pieno

Descrizione del lavoro

Continuity Biosciences, Inc. is hiring a Product Development Engineer II to advance intratumoral drug delivery implants. You will work hands-on in our Cary lab and ISO 7 cleanroom, translating lab assemblies into repeatable manufacturing processes for clinical release.

Role growth includes ownership of design history files, partner management, and program reporting. The ideal candidate has strong aseptic technique, design controls, and SolidWorks skills, with a track record of solving complex

Competenze

• A Bachelor's or Master's degree in biomedical, mechanical, chemical, or materials engineering and 3+ years of industry experience in medical device or combination product development, or a PhD in one of these fields and at least 1 year of medical device or pharmaceutical industry experience.
• Hands-on aseptic technique and experience in a cleanroom or GMP environment.
• Experience with design controls (21 CFR 820.30, ISO 13485), verification testing with statistically justified sample sizes, and SOPs/batch records.
• Proficiency in SolidWorks or similar 3D CAD for fixtures, tooling, and component drawings.
• Record of solving technical problems independently and communicating results to leadership.

Mansioni

• Build and package devices, including aseptic work for preclinical and clinical studies.
• Transfer assembly processes from lab to cleanroom and develop manufacturing steps for clinical release.
• Develop lab-scale manufacturing steps, including lyophilization of biologics.
• Plan and build preclinical device lots for multi-site animal studies with proper labeling and chain-of-custody.

Conoscenze

Aseptic technique

Cleanroom operation

Design verification/validation

Communication to leadership

Project ownership

Formazione

Bachelor's or Master's in biomedical/mechanical/chemical/materials engineering

PhD in related field (optional)

Strumenti

SolidWorks

Descrizione del lavoro

About Continuity Biosciences

Continuity Biosciences is a clinical stage biotechnology company in the Cary, North Carolina area. We develop precision drug delivery platforms that change how and where therapies reach patients, across oncology, Type 1 diabetes, HIV prevention, and medical aesthetics. Our lead oncology program has advanced into its first clinical trial in patients. We are a small, fast-moving team building a company where individual ownership has outsized impact.

The Role

We are hiring a Product Development Engineer II to help develop our intratumoral drug delivery implants, used across several combination product programs. You will work hands-on in our lab and ISO 7 cleanroom, building devices and working with the team to turn lab assembly processes into documented, repeatable manufacturing processes for clinical product release. Over time, the role has the potential to lead programs, including ownership of the design history file, partner management, and program reporting.

What You'll Do

Device building and process development

• Build and package devices, including aseptic work in a biosafety cabinet, for preclinical and clinical studies.


• Transfer device assembly processes from an academic laboratory into our cleanroom, and develop a manufacturing process suitable for clinical product release.


• Develop lab-scale manufacturing steps, including lyophilization of biologic drug products.


• Plan and build preclinical device lots for multi-site animal studies, with labeling, shipment, and chain-of-custody records.

Cleanroom and quality

• Support commissioning of the cleanroom and its equipment (IQ/OQ/PQ), and set up environmental monitoring, gowning, and cleaning procedures.


• Lead operator qualification and reproducibility studies, including media fills.


• Train and direct manufacturing technicians, and own deviations, nonconformances, and process changes.

Design and documentation

• Write and execute design verification protocols for drug release, mechanical integrity, and gas-flow integrity.


• Maintain the design history file and risk management files with our quality team, including design and process FMEA under ISO 14971.


• Design fixtures and tooling in SolidWorks, work with machining and prototyping vendors, and prepare transfer to a contract manufacturer.

What You'll Bring

Must have

• A Bachelor's or Master's degree in biomedical, mechanical, chemical, or materials engineering and 3 or more years of industry experience in medical device or combination product development, or a PhD in one of these fields and at least 1 year of medical device or pharmaceutical industry experience.


• Hands-on aseptic technique and experience working in a cleanroom or GMP environment.


• Experience with design controls (21 CFR 820.30, ISO 13485), verification testing with statistically justified sample sizes, and process documentation such as SOPs and batch records.


• Proficiency in SolidWorks or a similar 3D CAD tool for fixtures, tooling, and component drawings.


• A record of solving technical problems independently and carrying the solution through to implementation, with clear communication and comfort presenting results to leadership.

Nice to have

• Experience with process development, transfer, or validation for implantable or combination products.


• Experience with lyophilization or antibody handling.


• Familiarity with sterility and endotoxin testing (USP <71> and <85>) and aseptic process simulation.


• Experience working with external vendors such as machine shops, component suppliers, or test laboratories.


• Experience supervising technicians or junior engineers.

Location & Work Arrangement

This is a full time, in person role at our Cary, North Carolina development center, with regular work in our ISO 7 cleanroom. Build and shipping dates occasionally require early starts or late finishes, and the position includes some travel, approximately 10% of the time.

Compensation

A competitive base salary commensurate with experience, plus equity. As an early-stage company, we offer equity that gives you real ownership in what you help build.

Why Join

• Help bring a local cancer therapy platform into the clinic.


• Build a manufacturing process and cleanroom operation in a growing company.


• A path to leading programs, in a small team with real equity.