Lin Qiao Email and Phone Number

Provide quality assurance and engineering guidance to drug product development to ensure compliance to medical device/combination product QMS. Core activities include advising multi-functional groups on requirements of 21 CFR 820.30 (Design Control) and 21 CFR Part 4 (combination product), overseeing engineer and GMP runs at CMO facilities, supporting BLA/EMA regulatory filings. Significant experience in European considerations for combination products by performing impact evaluations of Medical Device Regulation 2017/745 (MDR) and ISO 13485:2016 on current QMS and strategizing device declaration for EU approval.

Manage multiple projects from concept through post-launch with responsibility for business case establishment, timeline/budget development and monitor, equipment and process development, design control, product verification and validation. Develop single-use endoscope for retinal and glaucoma surgery, medium-term biodegradable punctual plug for dry eye treatment, new and line extension single-use ophthalmic cannulas for cataract and retinal surgery. Facilitate collecting voice of customer, defining user requirements, and developing design criteria, design input/output. Lead cross-functional team to define project scope and product concept, establish business case, develop WBS and project schedule, build resource needs and budget, conduct risk analysis and develop mitigation plan. Work with supply chain to develop procurement strategy for sourcing critical components by evaluating and selecting perspective suppliers. Lead development team to design robust products by following design control requirements (i.e. design matrix, design input, design output, DFMEA, PFMEA, and design validation), to develop prototypes, proof of concept, and manufacturing process, to transfer and validate process/products to operation or OEM supplier. Define regulatory paths and necessary testing of degradation study, shelf life, biocompatibilities and process validations for FDA 510(k) submission and CE Certification. Lead efforts to transfer acquired of Fluid controlled product line to site. Identify and procure necessary manufacturing equipment, design and install microbial free water system, perform IQ, OQ and PQ manufacturing equipment and process, prepare SOPs and transfer the validated process to operation.

• Managed site sterilization program including radiation and ethylene oxide sterilization for single-use instruments and autoclave sterilization for re-usable instrument to ensure that sterile products comply with ISO requirement and FDA/EU regulations. Provided support and guidance on sterilization and package requirements to Engineering and Operation with regards to new product development and process improvement of existing products. • Led microbiology team to set up site microbiology lab and establish routine microbiological evaluation and DQA testing for single-use sterile products. • Assumed material SME responsibility for material selection in new product development. Facilitated biological evaluation for hazard analysis and safety risk assessment per ISO10993, 14971 and other regulatory requirements.

• Managed technology and manufacturing transfer of acquired platform combination product, ocular bandage. Led crossfunctional team to identify and set up manufacturing area and testing lab, procured production equipment and testing instruments. • Validated manufacturing equipment and process for ocular bandage material. Developed, optimized, and validated test methods using HPLC, GC, FT-IR, GPC and wet chemistry for incoming raw materials and final product inspection per EU and ISO requirements. Performed fill-finish process development, dose volume and accuracy evaluation, extractable and leachable, and container closure integrity testing. • Led team to prepare Technical File and performed all necessary testing per ISO standards, including biological evaluation, packaging, and established shelf life. Guided approval process to obtain CE Mark certification and launched as Ocuseal®

• Managed a group of chemists to develop and optimize new HPLC and GC/MS methods for testing drug eluting stent and vascular C-Qur mesh product. • Defined and established quality specifications for incoming materials/components, in-process formulations, and final assembled devices. Designed vendor qualification and certification programs in collaboration with material management associates.• Teamed with engineering, manufacturing, regulatory, and technical associates with regard to product cGMP compliance, regulatory submission, validation strategy, and quality systems of cardiological vascular platform.

• Provided chemical and analytical expertise in support of analytical method development of HPLC, GC, GC/MS, UV/Vis, FTIR, DSC and TGA for new contact lens material. Developed and executed qualification and validation protocols for test methods and manufacturing processes.• Developed inspection procedures, specifications, and sample plan for incoming raw material, finished hydrogel contact lens material, and intraocular lens material in accordance with industry standards.• Lead CAPA project team to perform risk and root cause analysis, to develop preventive action plan, and to prepare project reports along with recommendations to management team to ensure timely and effective implementation.• Facilitated programs for product and process improvement. Developed and implemented innovative processes/technologies to support continuous improvement of existing products, manufacturing operations, and test methods.

• Conducted formulation scale-up and production of hydrogel lens material at both pilot and manufacturing scales. Prepared and executed process validations according to FDA and ISO requirements.• Evaluated and analyzed chemical and physical properties of contact lens materials. Provided technical support to resolve issues of analytical equipment and raw materials, as well as to perform product failure analysis and complaint investigations.