Platform Performance and Mechanical Testing Lead

Company Overview

Lyndra Therapeutics is a clinical-stage biopharmaceutical company partnering to create and commercialize long-acting oral therapies. Our LYNX drug delivery platform transforms daily medicines into treatments that last a week or longer in a single oral dose. With the LYNX platform, we have the potential to fundamentally change how medicines are taken and delivered.

Position Overview

The Platform Performance and Mechanical Testing Lead is an individual experienced in test method development and validation. The individual in this role will lead the platform testing team, drive the development of novel test methods, and work cross-functionally to inform the successful advancement of Lyndra's innovative LYNX platform. They will bring experience in understanding Critical Quality Attributes (CQAs) and developing/validating test methods to demonstrate that the product meets the defined CQAs. They will be responsible for leading the team performing platform testing, data analysis, and reporting for the platform. This individual will collaborate across disciplines to share data and insights and to help inform key platform decisions. This individual will be a "player and coach", willing to take an active role in test method development while coaching and leading the team supporting development and test execution. This role is onsite, based primarily in our Watertown MA site.

Responsibilities:

• Lead the strategic development, validation, and execution of novel in vitro/mechanical test methods to predict in vivo performance for the LYNX drug delivery platform technology
• Steer decision making and prioritization related to platform performance, mechanical test method development and execution
• Lead and coach team to drive high performance culture that accommodates rapid and dynamic development
• Ensure test execution of all development and routine testing, analysis of results, and correlation to in vivo data
• Lead/support mechanical design of test method fixturing and equipment
• Ability to support hands-on testing and in-lab development activities, as needed
• Work collaboratively with the materials characterization, formulation, and process development teams, as well as project management, to meet the current and future needs of programs
• Prepare specifications and/or targets for platform performance tests
• Clearly align and communicate key outputs/learnings from test method development efforts and ensure knowledge is shared cross-functionally and across programs
• Write and/or review CMC sections of regulatory documents and submissions

Qualifications:

• BS Degree in Engineering, Chemistry, Materials Science or related field is required; an advanced degree (MS, PhD, PharmD) is preferred
• Minimum of 5 years' experience in mechanical test method development and validation for drug delivery technology, combination products, and/or medical devices
• Experienced in mechanical design of fixturing and/or tooling, and computer-aided design (CAD) software programs
• Strong data analysis skills; proficient in coding (such as Python or other programming) and/or statistical modeling (such as JMP)
• Experience using 3D printing technology
• Knowledge in polymer chemistry, material properties, and materials characterization is a plus
• Proven ability to mentor and coach more junior team members and develop a strong scientific team
• Strong leadership and communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders
• Demonstrated ability to work in ambiguous/changing conditions and understand complex projects with multiple inputs, outputs, and variables; great attention to detail
• Excellent analytical and problem-solving skills with the ability to adapt to changing priorities and deadlines
• Track record of achievement through teamwork