Christopher Weinert Email & Phone Number

United States

Waltham

Build in-house design verification testing systems and infrastructureDevelop and validate drug delivery systems test methods Execute engineering and design verification testing to support health authority filings, e.g., NDA, CTA

Cambridge, Massachusetts, United States

• Lead in-house commercial design verification of direct-to-safety syringe Vutrisiran program, including: - Functional testing - Accelerated and Real Time performance - Statistical analysis - NDA technical support; approval June 2022• Hire and train technical talent

Cambridge, Ma

• Combination product development - Establish in-house test methods, fixture design, method validation and Design Verification for PFS and safety system drug delivery devices.• Implemented paradigm-breaking in-house design verification lab. • Start-to-finish design verification for Vutrisiran direct to safety syringe clinical program.

Cambridge, Ma

• Drove Design for Manufacturing/Assembly for 10+/-MM units/yr large volume high viscosity patch injector program• Developed manufacturing processes and requirements for large molecule autoinjector programs; worked with teams to socialize robust development tools: DFM, formal risk management, design edge of failure analysis, gaging studies, tolerance analysis, product and process CTQs• Resolved high value CMO process risks through equipment and process improvements in existing $3B portfolio • Lead engineer for 600K units/yr external manufacture of Avonex pens; investigated and addressed root causes of equipment and PFS/pen component issues; $1.2B commercial sales• Developed/implemented CMO process to reliably relabel vials for five billion IUs Alprolix/Eloctate donation under extreme time constraint

Raynham, Ma

• Developed superior ACL reconstruction adjustable suture loop button implants – project lead – est $20MM/yr• Led international commercialization team for fixed-loop button-textile ligament repair device – $10MM/yr• Inspired / developed 3-5 engineers on independent projects - hiring, feedback, performance management, promotion.• Portfolio Steering team –ranked needs and programs for $500MM product development pipeline.• Led Mitek’s R&D Culture Initiative – foster employee engagement & functional relationships Mitek.• Pitched, chartered & led disposables kit project based on clear user needs and business case ~$5MM/yr.

Raynham, Ma

New Product Development (R&D) – Knee repairs – Project Leader | 2011 – 2012• Led $15MM bio-absorbable interference screw development program; international team of 13.• Turned around ‘Team in turmoil’ – in 3 months, re-established rapport in a team of 12, restored management confidence in team, and delivered to critical project timeline.• Managed 3 engineering direct reports; goal setting, feedback, performance management, promotion• Created Mitek R&D Culture Team - envisioned and initiated in 2010: increased engagement across 70 person unit, improved intra-R&D relations and increased retention via team building, group branding & recognition.New Product Development –Arthroscopy Equipment – Project Leader | 2010 – 2011• Addressed unmet usability and performance needs with game-changing, disposable, arthroscopic RF electrode. ($20MM/yr); led international, multi-company team of 14.• Managed 3 engineering direct reports on independent electromechanical projects; promoted 2.New Product Development –Shoulder repairs – Project Leader | 2005 – 2009• Revitalized Mitek shoulder anchor business by launching PEEK and biocomposite (PLGA/TCP) anchor projects. for RC and instability repairs; led international team of 10; Healix and Gryphon anchors, $25MM/yr.• Revolutionized RC suture passing with ExpresSew II reusable arthroscopic passer, $15MM/yr. New Product Development – Tissue management | 2003 – 2005• Established validated assembly/inspection process for novel RetroJet water jet disposable surgical device.• Overcame textbook barriers and built/tested concepts of autoclavable 20 ksi surgical fluid jet pump.

• Implemented lean flow on MicroSeal Adaptor line resulting in 400% throughput improvement.• Owned assembly process and mitigated production issues for GuardWire, MicroSeal Adaptor and Export catheter assembly lines.

New Product Development Engineer - Endovascular Implantable Devices | Warren, NJ | 2001-2002• Validated cutting/finishing/inspection process for $70MM/yr Palmaz Genesis balloon expandable stent project.• Developed innovative LASER cutting method to overcome historic tooling limitation for new stent.Process Engineer– Endovascular Stent and Catheter Delivery System Assembly | Miami Lakes, FL | 1999-2000• Led SMART NITINOL stent manufacturing engineering team through growth from $20MM to $120MM– 4 direct reports.• Designed and validated catheter trimming tooling that reduced scrap by greater than $500M annually.• Improved stent crimping yield from 85% to 93% ($300M / year) on a Process Excellence team.

Bs, Env Engineering

Ms, Civil Engineering