Facilities Engineer

Innoviva Specialty Therapeutics, Inc. provided pay range

This range is provided by Innoviva Specialty Therapeutics, Inc. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

Nortiva Bio, Inc., a subsidiary of Innoviva, Inc., is a clinical‑stage biopharmaceutical company pioneering long‑acting oral therapies. The company’s proprietary LYNX™ drug delivery platform represents a major advancement in oral drug delivery, enabling the creation of medicines designed to last a week or longer in a single oral dose. Our near‑term focus is on advancing clinical programs in therapeutic areas where weekly or monthly doses would improve adherence and health outcomes.

Nortiva Bio, Inc. is seeking an experienced Test Engineer to drive characterization of novel long‑acting oral drug products. Nortiva’s ultra‑long‑acting oral drug delivery platform uniquely combines elements of controlled drug delivery, traditional and non‑traditional formulation components and processes, and dynamic structural features required for gastric residence. In this role, you will be responsible for developing and executing laboratory methods to assess physical properties of Nortiva’s long‑acting oral products, ensuring phase‑appropriate methods and specifications are in place to assess Critical Quality Attributes (CQAs) for clinical trial material.

The ideal candidate brings experience in mechanical characterization of polymeric materials in biological environments as well as experience in mechanical test development, validation, and verification for medical devices. Strong skills in innovation, attention to detail, clear communication/documentation, and team collaboration are essential. This role is primarily onsite in Lexington, MA.

• Drive strategic development, validation, and execution of novel in‑vitro /mechanical test methods to predict in‑vivo performance for the drug delivery platform technology
• Develop phase‑appropriate methods and specifications for critical physical attributes of the product, validate methods, support batch release and stability
• Ensure execution of all development and routine testing, analyze results, and correlate to in‑vivo data
• Lead/support mechanical design of test method fixturing and equipment
• Work collaboratively with formulation, engineering, and project management functions to meet timelines and prioritize efforts
• Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross‑functionally
• Author and/or review CMC sections of regulatory documents and submissions

• BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field is required; an advanced degree (MS, PhD, Pharm
  
  D) is preferred
• 3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants
• Experience with testing plastic materials that are implanted or ingested preferred
• Knowledgeable of the fundamentals of polymer chemistry, material properties, and composites

• Strong data analysis skills, including design of experiments and/or statistical modeling using software such as JMP
• Familiar with mechanical design of fixturing and/or tooling, computer‑aided design (CAD) software programs, and 3D printing technology
• Excellent analytical and problem‑solving skills; fast learner with the ability to adapt to changing priorities and thrive in a fast‑paced environment
• Eagerness to support teammates across functions, providing hands‑on support for testing and manufacturing as needed

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

Nortiva Bio, Inc. is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.