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Innoviva Specialty Therapeutics, Inc. · 2 weeks ago

Mechanical Test Engineer-Drug Delivery System

Lexington, MA

Full-time

Onsite

Mid Level

3+ years exp

Nortiva Bio, Inc. is a clinical-stage biopharmaceutical company pioneering long-acting oral therapies. They are seeking an experienced Test Engineer to drive characterization of novel long-acting oral drug products and ensure methods are in place to assess Critical Quality Attributes for clinical trial material.

BiotechnologyMedicalTherapeutics

Responsibilities

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

Qualification

Mechanical test developmentPolymer characterizationData analysisMechanical designStatistical modelingComputer-aided design (CAD)Team collaborationClear communicationProblem-solving

Required

BS Degree in Mechanical Engineering, Chemical Engineering, Bioengineering, Materials Science, or related field

3+ years of experience in mechanical test method development and validation for drug delivery technologies, combination products, or medical implants

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

Preferred

An advanced degree (MS, PhD, PharmD)

Experience with testing plastic materials that are implanted or ingested

Company

Innoviva Specialty Therapeutics, Inc.

Innoviva Specialty Therapeutics, Inc., a subsidiary of Innoviva, Inc., is a biopharmaceutical company focused on developing innovative solutions for patients and healthcare providers in the fields of Critical Care and Infectious Diseases.

Founded in 2023

Waltham, Massachusetts, USA

51-200 employees