.Yanli Mi
Scientist /Senior Manager
LINKS
https://www.linkedin.com/in/yanli-mi-4b23432
Summary
• A driven and energetic pharmaceutical professional. Always improving self and embracing new challenges. Good at communication and teamwork.
• Ten plus years of industry experience in pharmaceutical and biological arenas working with interdisciplinary teams and managing CMOs / CROs domestically and internationally, I provided technical leadership for early / late stages of various drug development (Small and large molecules).
• Proficient at cGMP requirements with ICH, USP and FDA guidelines, I provided successful global regulatory and technical support gaining FDA and EMEA approval. I also mastered effective negotiation, problem solving, strategic planning, collaborative teamwork, interpersonal relationship, communication and other leadership skills, with an emphasis on efficiency, compliance, business logistics and result-oriented for project management, budgets, milestones, timelines and deliverables.
• Ten plus years of industry experience in pharmaceutical and biological arenas working with interdisciplinary teams and managing CMOs / CROs domestically and internationally, I provided technical leadership for early / late stages of various drug development (Small and large molecules).
• Proficient at cGMP requirements with ICH, USP and FDA guidelines, I provided successful global regulatory and technical support gaining FDA and EMEA approval. I also mastered effective negotiation, problem solving, strategic planning, collaborative teamwork, interpersonal relationship, communication and other leadership skills, with an emphasis on efficiency, compliance, business logistics and result-oriented for project management, budgets, milestones, timelines and deliverables.
Experience
Scientist II/Senior Manager
Gilead Sciences
• Support the analytical activities and CMC sections for two approved HIV combination therapies (two, three and four drug single tablet regimens) Descovy and Genvoya.
• Lead a group of 8 scientists and associates for the data review and quality control for successful NDA submission for recently approved HIV combination therapy (three drug single tablet regimens) Odefsy.
• Oversee, coordinate and summarize reports for the development and QC activities at contract research/testing labs for method validation, method transfer, primary stability, and bulk hold time studies to support both CMC sections of regulatory submissions, to respond to questions from regulatory agencies/health authorities, and to support several programs of the clinical, market and post-approval manufacturing campaigns.
• Execute analytical method development and validation, and author validation and stability reports for Ebola project in clinical phase, for both solution and lyophilized formulations.
• Lead a group of 8 scientists and associates for the data review and quality control for successful NDA submission for recently approved HIV combination therapy (three drug single tablet regimens) Odefsy.
• Oversee, coordinate and summarize reports for the development and QC activities at contract research/testing labs for method validation, method transfer, primary stability, and bulk hold time studies to support both CMC sections of regulatory submissions, to respond to questions from regulatory agencies/health authorities, and to support several programs of the clinical, market and post-approval manufacturing campaigns.
• Execute analytical method development and validation, and author validation and stability reports for Ebola project in clinical phase, for both solution and lyophilized formulations.
Consultant /Contractor
Validant Consulting for Gilead Sciences
Extensive data review for clinical and commercial quality control groups from Gilead and its various contract manufacturers, including commercial / clinical stability and release data packages, and analytical method validation for API and drug products of more than ten projects, including the most well-known Gilead HIV (single, two, three and four drug into single tablet regimens, the previous and the current generations) and HCV market products (including Savoldi and Harvoni).
Owner / Co-Founder /Consultant
Current Pharmaceuticals/Other companies
• Owner of self-registered Current Pharmaceuticals, a platform to consult and collaborate various projects, including supporting API and drug product manufacture, outsourcing, analytical method and formulation development, drug delivery technology, quality assurance, animal and PK studies, business development, and regulatory considerations for CMOs and start-ups in China.
• Co-founder.
• Assisted with Sichuan Pharmaceuticals Inc. and Sichuan Ke Chuang Pharmaceutical Group to identify and introduce new nutritional and therapeutic candidates into their future pipeline.
• Co-founder.
• Assisted with Sichuan Pharmaceuticals Inc. and Sichuan Ke Chuang Pharmaceutical Group to identify and introduce new nutritional and therapeutic candidates into their future pipeline.
Scientist / Group Leader
MedImmune
• Led and participated in cross-site and cross-functional teams to provide technical expertise of drug product manufacture and process improvements for nasal-spray influenza Flumist and H1N1 (tri- & quadrivalent) vaccine, and other early stage candidates (protein-adjuvant systems, live attenuated viral vectors).
• Conducted analytical / formulation / technology screening, stability, scale-up / down, biophysical characterization, supporting single-use & re-usable systems, product complaints & investigations.
• Oversaw bulk sterile fill finish processes for clinical and marketing materials, and alternative device development (e.g., BFS, including writing device history files), proactively ensuring consistent practices of manufacture processes among internal and global manufacture sites (US & Europe).
• Executed and troubleshot the non-discrepancy quality from different batches of vaccine products. Authored and reviewed protocols, batch records, technical reports, process validation documents, and successful regulatory filings (BLA, MAA) and inspections including several sBLA, IND.
• Conducted analytical / formulation / technology screening, stability, scale-up / down, biophysical characterization, supporting single-use & re-usable systems, product complaints & investigations.
• Oversaw bulk sterile fill finish processes for clinical and marketing materials, and alternative device development (e.g., BFS, including writing device history files), proactively ensuring consistent practices of manufacture processes among internal and global manufacture sites (US & Europe).
• Executed and troubleshot the non-discrepancy quality from different batches of vaccine products. Authored and reviewed protocols, batch records, technical reports, process validation documents, and successful regulatory filings (BLA, MAA) and inspections including several sBLA, IND.
Scientist /Group Leader
PDL BioPharma
• Managed a group of 5 scientists and associates to lead four projects (phase I to phase III monoclonal antibody, phase II peptide, post-market and life cycle management small molecule market products) for the formulation and process development in house, and by collaborating and transferring projects among CMO/CRO organizations.
• Coordinated internal pre-formulation and formulation studies, lead selection, stability program management, scalable manufacturing process, alternative devices evaluation (pre-filled syringe vs vials), optimization of liquid and lyophilization processes.
• Improved the formulation and process by directly or indirectly participating the stability and compatibility studies of formulation screening by using various analytical methods, such as, HPLC-(SEC,RP,IEC,HIC), cell-, immune- (ELISA, etc), capillary electrophoresis-(CE-SDS), particle analysis (HIAC,AUC) and spectroscopy-based (UV,FT-IR, CD, Fluorescence) methods, and by characterizing biochemical and biophysical properties or devices, proteins and their degradation products.
• Authored scientific posters, publications and regulatory filing and responded to FDA questions.
• Led or supported different stages of due diligence activities from scientific aspects to showcase projects for company merge and acquisition efforts. Transferred the entire QC and stability data archives from Minnesota to California site before acquisition.
• Coordinated internal pre-formulation and formulation studies, lead selection, stability program management, scalable manufacturing process, alternative devices evaluation (pre-filled syringe vs vials), optimization of liquid and lyophilization processes.
• Improved the formulation and process by directly or indirectly participating the stability and compatibility studies of formulation screening by using various analytical methods, such as, HPLC-(SEC,RP,IEC,HIC), cell-, immune- (ELISA, etc), capillary electrophoresis-(CE-SDS), particle analysis (HIAC,AUC) and spectroscopy-based (UV,FT-IR, CD, Fluorescence) methods, and by characterizing biochemical and biophysical properties or devices, proteins and their degradation products.
• Authored scientific posters, publications and regulatory filing and responded to FDA questions.
• Led or supported different stages of due diligence activities from scientific aspects to showcase projects for company merge and acquisition efforts. Transferred the entire QC and stability data archives from Minnesota to California site before acquisition.
Research Scientist
Array BioPharma Inc.
Entirely responsible from lab work to IND enabling/ writing including all pre-formulation studies, analytical methods development for various solid and liquid physico-chemical characterization.
Scientist to Senior Scientist
Pfizer
• Project lead for oncology and HIV Phase III lyophilized products representing the process development and technology transfer team, working with internal labs, cross-site organizations and CMOs to trouble shoot and resolve any QA investigations, and contributed to successful NDA filing.
• Improved the overall liquid lab capacity for sterile product development, including new technology evaluation and introduction, equipment and process validation.
• Ensured supply of small and large scale (scale up and down) clinical and commercial batches by leading technology development / transfer for sterile and tablet products (formulation / process / packaging / labeling / manufacturing parameters) to and from external labs and CMOs.
• Improved the overall liquid lab capacity for sterile product development, including new technology evaluation and introduction, equipment and process validation.
• Ensured supply of small and large scale (scale up and down) clinical and commercial batches by leading technology development / transfer for sterile and tablet products (formulation / process / packaging / labeling / manufacturing parameters) to and from external labs and CMOs.
Sales Manager
Novartis Pharma (merged from Ciba-Geigy)
• Established sales channels and negotiated business agreements / terms / conditions for all OTC products in the Beijing region.
• Co-developed and executed marketing strategies, by working with consulting companies such as McKinsey, and with both wholesale and retail sellers.
• Promoted awareness of Novartis market products by regular product presentations, national and regional conferences, pharmacy and hospital visits, and placement of subway, public space for posters, light boxes and TV advertisements.
• Co-developed and executed marketing strategies, by working with consulting companies such as McKinsey, and with both wholesale and retail sellers.
• Promoted awareness of Novartis market products by regular product presentations, national and regional conferences, pharmacy and hospital visits, and placement of subway, public space for posters, light boxes and TV advertisements.
Dentist
Beijing Dental Hospital Clinic, Chengdu 69 Hospital
General dental practice /treatment in public hospitals and private clinics.
Volunteer Experience & Causes
Captain for Gilead GGR running team
CrowdRise
Health
Led Gilead team to raise funds (ranked as 3rd fundraiser among all teams), and ran a fantastic race
Board memeber /Ad coordinator for newsletter and communication
San Mateo mother club
– (10 months)Children
Board member with other moms to run San Mateo club, responsible for promoting mother club and coordinating the advertisements from local business for the mother club newsletter and online publication.
Facilitator
CASSS
Science and Technology
Facilitated rountable discussion for "Don't Get in A Bind Over Specifications"
Garden teacher
Highlands Elementry School
– Present (1 year 6 months)Education
Taught 3rd graders design, maintain and love organic gardening
Education
Ph.D., Pharmaceutical Sciences, University of Tennessee, U.S. 1998 - 2002
Doctor of Philosophy (Ph.D.), Pharmaceutical Sciences
Chinese Academy of Medical Sciences
Master's degree, Pharmacology
Ended study before 3rd graduation year to US for a Ph.D. program
Beijing Medical University
Bachelor of Medicine, Stomatology
Activities and Societies: Editor-in-chief of Monthly Campus Journal
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