Ming-Chia (Roland) Huang

*** *** ***********

Acton, MA 01718

Home phone: 978-***-**** Mobile: 978-***-****

Fax: 978-***-****

E-mail: adc34g@r.postjobfree.com

PROFESSIONALSKILLS

Product Development, Quality Control and Quality Assurance/CMC Submission

- Thirty years’ experience in R&D environment with responsibility for product development and chemistry as required for regulatory applications.

- Experienced with working with Contract Development and Manufacturing Organizations (CDMO), and Contract Laboratory for manufacturing processes and laboratory activities.

- More than 20 years experience with Quality Assurance, Quality Control, analytical methods development and validation, technical transfer, stability software (SLIMStat, SAS, JMP) and stability data trending.

- Familiar with QDoCC, OPM, SAP, QT9, and TrackWise

- Familiar with 21 CFR 210, 211, 820, EudraLex GMP Guidance, and ISO 13485

- Vendor management and schedule audit plan and act as co-auditor during vendor site audit.

- Familiar with different dosage forms: OSD, Lyophilization (HYNIC-rh-annexin V, 99mTc-Recombinant Human Annexin V), Injections, Cream/Gel and medical device with drug combination products (implants with drug)

EXPERIENCE

TARIS Biomedical, LLC Lexington, MA Apr 2019 – Dec 2019

Associate Director, Quality Assurance

Represent QA function in technology assessments, device conception, design development and performance.

Represent QA function in PD projects to develop DHFs, DMRs, and creating and maintaining DMFs.

Familiar with 21 CFR 210, 211, 820, EudraLex GMP Guidance, and ISO 13485

Work closely with PD in design control activities, including translation of user needs to design requirements, product performance specifications, design verification and validation, lead risk management activities including risk management plan, hazard analysis, and FMEAs.

Represent QA function on product development, testing, manufacturing and others in the developmental process, vendor QA activities such as analytical methods transfer and validation, support sterilization validation, label control and qualification.

Manage quality oversight of all vendors including Manufacturers, Packagers, Laboratories, process improvement activities and vendor control.

Deviations, Investigations and CAPA – assist R&D teams in ensuring deviations, CAPAs and investigations are fully addressed and close in a timely fashion. React decisively to a wide range of non-conformance events, CAPAs, and other quality/compliance indicators.

Be responsible for Supplier Quality agreements, supplier control, Audits and follow-ups, QP relationship management, external product control, intermediates release and distribution oversight, vendor qualification and AVL program.

Be responsible for activities related to specifications, changes, change logs, assist Quality management on external regulatory and compliance related matters, audits, Quality Agreements, vendor non-conformances, investigations, change controls and product complaints.

Takeda Pharmaceutical, Inc. Cambridge, MA

Project Manager, GMP Quality Assurance (small molecule) Jan 2014 – Apr 2019

• Employ GMP QA expertise and principles during the development, manufacturing, testing, packaging and release of investigational API and drug product (collectively Clinical Trial Material, CTM) to ensure product quality, solve project problems, significantly influence the compliance of projects/programs, and achieve business goals.

Provide strategic GMP quality/compliance guidance to internal stakeholders by serving as GMP QA authority on pharmaceutical development/CMC teams.

Provide strategic GMP guidance to third-party vendors to ensure quality and compliance of Takeda products.

Oversee and conduct final release and disposition of CTM for use in Takeda-sponsored studies.

Investigate product complaints through evaluation of batch record documentation and interactions with internal and external technical personnel.

Serve as GMP QA subject matter expert in the review and approval of stability protocols/reports, test method validations and specifications, as well as in the resolution of investigations, deviations, and out-of-specification investigations.

Lead comprehensive GMP Quality audits of current or new vendors in support of Takeda’s CTM supply chain. Make recommendations to management concerning the use of vendors based on audit findings.

Manage internal quality improvement initiatives: evaluate internal processes; suggest/design/implement improvements; create/revise relevant SOPs.

Support inspectional readiness activities at external vendors (e.g., manufacturers, packagers, and laboratories) related to Takeda regulatory submissions. Effectively interact with QA senior management and internal stakeholders to implement inspectional readiness strategies, assess potential risks, and determine necessary actions to mitigate risks.

Ensure Annex 16 and QP release requirements for my programs, as required for EU programs

Vertex Pharmaceutical, Inc. Cambridge, MA

Quality Manager – GMP-Quality Jun 2011 – Nov 2013

Provides quality oversight and sets strategy for process validation, cleaning validation, method validation, and/or product stability activities.

Work closely with CD, AD, and FD for Phase I-III product development as development QA representative in daily activities.

Reviews trend reports for product quality events (deviations, OOS, product complaints, CAPA) and ensures appropriate implementation plans are identified and completed for CAPA’s.

Develops and/or maintains quality systems to support kilo lab manufacture, and test in GMP QC lab; including writing/approving SOPs.

Review CMC section in the IND, IMPD, EOP2, and NDA submission

Support packaging and labelling batch record review and batch disposition.

Quality Lead GMP-Quality Mar 2008 - Jun 2011

Responsible for the Validation oversight at Vertex Contract Manufacturing Organizations (CMO), development and administration of Quality Agreements and Investigation Management.

Responsible for review of master and executed records for Drug Substance, Intermediate Drug Product, Bulk Drug Product, Packaged & Labeled Drug Product

Management of all applicable investigations associated with product, materials and Technical Complaints.

To ensure that change control, technical and compliance issues are consistently in a manner consistent with cGMP requirements, and will drive the review process to timely completion in order to support product disposition.

Review CMC section in the IND, IMPD, EOP2, and NDA submission

OOS/OOT, Non-conformance investigation in TrackWise and manage documents in QDoCC.

Perform batch disposition in OPM

Review test method, methods validation, validation protocols, and validation reports from CMOs.

Review on-going stability studies for drug substance, SDD, and drug product

Perform the batch analysis and stability data trending for drug substance, SDD, and drug product.

Sepracor Apr 2007-Mar 2008

Marlborough, MA

Development Quality Assurance (DQA) – Senior DQA Consultant

Coordinate product release activities including batch record review, testing, investigations, deviations and timing from contract lab.

Coordinate stability activities such as study design, launches, and data review and trending with statistical software.

Maintains stability database and incorporates all stability data to date into electronic format.

Evaluates, trends and reports stability data for internal use and for FDA via required periodic reports.

Conduct QC review of data associated with these drug product Development activities.

Coordinate the activities at various contractors to insure the availability of CMC data in a timely fashion.

Generate technical reports and data summaries for CMC sections of regulatory filings (stability information, release test data, sampling, methods validations, etc.) in IND or NDA.

Work closely with R&D for new drug development and support CMC of the IND submission.

Critical Therapeutics, Inc. Lexington, Massachusetts Sep 2004-Nov 2006

Jan 2006-Nov 2006

Sr. Manager, Quality Assurance/Analytical Science

Sept 2004-Dec 2005

Sr. Quality Scientist

Establishment of method validation and technical transfer policies for the company from contract lab.

Management of technical transfer program with and between vendors

Manage company’s method validation program

Providing scientific expertise for analytical method development efforts

Acting as Quality’s scientific evaluation liaison with contract vendors

Manage drug product and drug substance stability programs

Conduct scientific evaluation of product performance

Participating in drafting analytical CMC sections of regulatory filings

Provide scientific guidance regarding proposed and current compendial and regulatory guidances related to company’s products.

Support Quality Systems as required

Theseus Imaging Corporation Jan-Sep 2004

Worcester, Massachusetts

Sr. Analytical Chemist, Quality Control

Qualification of analytical methods to assure suitability of use for release and stability testing of raw materials and finished products

Generation of SOPs, protocols, and technical reports

Control Delivery Systems, Inc. Apr 2000-Dec 2003

Watertown, Massachusetts

Manager, Quality Control (Analytical Technical Support)

Managed, trained, and supervised analytical chemists responsible for development and validation of test methods for raw materials and finished products

Prepared regulatory documentation and validation reports required for CMC section of NDA applications

Reviewed all analytical data to ensure they were generated according to the approved test methods and that they met specifications

Key person in developing for major product an HPLC method with the separation of active compound and 15 impurities

Set up new QC lab to comply with cGMP requirements

Prepared and generated method training and transfer protocols and reports between CDS and B&L, Waterford, Ireland

Copley Pharmaceuticals, Inc. Feb 1988-Mar 2000

Canton, Massachusetts

Manager, Method Development Sept 1998-Mar 2000

Managed the method development chemists on projects for ANDA submissions

Reviewed and scheduled projects, assigned priorities for stability testing chemists

Audited and checked analytical test methods, validation reports, and release certifications for ANDA submission batches

Senior Scientist, Method Development Feb 1988-Aug 1998

Developed and validated more than fifteen chromatographic stability-indicating procedures for new product applications; products included: tablets, capsules, liquids, creams, gels, suspensions, powders, and sustainedrelease dosage forms

Supervised and trained stability chemists on the performance and validation of finished product procedures

Responsible for project literature search through internet or local libraries (MIT, MCP, and Harvard Medical libraries).

Experienced with HPLC, UV/VIS, dissolution and instrument qualification and troubleshooting

EDUCATION

M.S. in Biopharmaceutics 1990

Massachusetts College of Pharmacy

Boston, Massachusetts

B.S. in Pharmacy 1980

Kaohsiung Medical College, School of Pharmacy

Kaohsiung, Taiwan, R.O.C.

ANDA/NDA and Phase I-III products

Copley – ANDAs

CDS – NDA for Retisert (fluocinolone acetonide intravitreal implant) 0.59 mg

Sepracor – NDA for Brovana® (arformoterol tartrate) Inhalation Solution

Critical Therapeutics – sNDA/NDA for ZYFLO CR (zileuton extended release tablets)

Vertex – Phase II to Registration stage for Ivacaftor (VX-770) and Orkambi Lumacaftor/ivacaftor (VX-809/VX-770, both are QbD NDA submissions)

Takeda – Phase I-II and PV campaign

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