Philip Kong Email & Phone Number

Princeton, Nj, Us

Raritan, New Jersey, Us

Proactively plans, manages, monitors & support decision making in cross-functional project deliverables of Chemistry Manufacturing & Controls end-to-end process from pre-NME through commercial launch for (NDA) & large molecules (BLA) submission.• Translates CMC global strategy/forecast analysis into realistic and executable CMC deliverables with clearly worked out scenarios and crucial decision points based on CMC & commercial input.• Supports risk management process, specifically identification and development of mitigation strategies with Janssen Supply Chain, Joint CMC and Joint Project Management Teams.• Works in close collaboration with the CDT Program Management Leader (CDTL-PML) to ensure alignment of CDT, CMC and functional strategies.• Identify, develop and implement best practices related to CMC, PMT and NPT Teams.• Proactively outline new processes & supports integration of enabling technologies to drive efficiency, key milestones and organizational readiness to support project execution & successfully launch product.• Resource (FTE & OOP) and budget management in close partnership with functional financial planning, program coordinators and managers.• Acrobat Adobe & Microsoft Project Professionals & Teams, OneNote, Notebook, Planisware (V6), SharePoint & Tableau.

Provide management consulting services to community organizations. Attend analytical chemistry and scientific-technical seminars/symposiums/workshops with Eastern Analytical Symposium, Mercer County Library and Thermo-Fisher Scientific. Actively participate in activities with the Professional Service Group of Mercer County and Career Support Group.

New Brunswick, Nj, Us

Supported heritage, strategic Products, wound closure & repair and biosurgery biologics platforms for CE- and Non-CE mark products. Including sutures (absorbable/non absorbable), surgical staplers, clip appliers, hemostatic gelatin sponge, topical adhesion barriers, needles and gynecare/hernia mesh systems in a leading and innovating large medical device company.• Provided legalized and apostile documentation meeting regulatory compliance requirements to health authorities and author regulatory documents (annexures_addendums, authorizations, confirmations, declarations, power of attorney and tender bids). • Authored, linked & organized documents for MDRiM, international registrations and submissions.• Updated Design Dossier, Declaration of Conformity and Technical Files. EU Medical Device Directive Regulation.• Completed registration renewals, new product registrations and 510(k) clearance premarket submissions.• Completed BSI EC Design Examination Certificate Renewal Applications. • Ensured major & minor change controls, ADAPTIV notices (current, proposed, justification & implementation strategy), product release authorizations & review plans are: assessed, executed, implemented, completed, approved & closed.• Collaborated with cross functional global team affiliates including label, legal team, research & development, supply chain & senior management – escalate, influence and negotiate with internal/external business units. • Answered questions, complaints, remarks or suggestions related to analytics and specifications from regulatory health authorities & affiliates. • Prepared for and supported inspections & audits for assigned portfolio.• Regulatory risk assessment and strategy development for global post-approval changes and post-market regulatory activities while adhering to most current domestic, Brexit & international regulations & guidance’s.• Full lifecycle management of international submissions and regulatory quality review of submissions.

• Provide management consulting services to community organizations. Attend analytical chemistry and scientific-technical seminars/symposiums/workshops with Eastern Analytical Symposium, Mercer County Library and Thermo-Fisher Scientific. Actively participate in activities with the Professional Service Group of Mercer County and Career Support Group.

Raritan, New Jersey, Us

Specifications management for commercial prescription products of starting materials-API’s–drug products (DP) for small & large molecules. Analytical activities central point of contact with Supply Chain and Regulatory Affairs. Design & process improvement of specification from early development-commercial launch-divestiture. Product portfolio owner - development & lifecycle management, including:• Setting globally for APIs & commercial drug products and Justification & Implementation (jos–jnr) Strategy Reports thru consolidation development/post-approval information from supply chain sites &y suppliers.• Change controls for API & DP - small & large molecules. Monitor, communicate updates and reassignment of parent & child: owners, initiators, assessors and site/function & QA approvers. • Ensuring change controls, compliance, notices (current, proposed, justification & implementation strategy) and plans are: assessed, executed, implemented, completed, approved and closed.• Advised teams API & drug product strategy, methods & specifications analytics, processing & manufacturing issues. • Critical evaluation, interpretation of current files and data. Appropriate and timely preparation of documents.• Collaborated with cross functional teams - influencing internal/external business units & senior management.• Answered questions, complaints, remarks or suggestions related to analytics and specifications from regulatory authorities & affiliates. Prepared and supported Health Authority inspections & audits for assigned portfolio.

Brentford, Middlesex, Gb

Prepared chemistry, manufacturing & controls (CMC) information. Reviewed documents for global marketing of Consumer Healthcare products and medical devices (IND, NDA, CSA, MAA) for therapeutic areas of: gastrointestinal, pain management, respiratory and smoking cessation treatment-nicotine replacement therapy. Established working knowledge of current governmental & worldwide (ASEAN-JP, EU-EP, US-USP) requirements - initial registration, re-registration and post-approval changes. • Built global health agencies Response to Questions database with hyperlinks for executive team meeting. Formatted granularity-stylist documents and instructional/work-flow process guidance’s to increase efficiency & productivity. • Complex CTD-VDA assemblies including: amendments, annual reports, declarations & specifications (CAPA, CoA, CCS, CPP, CTS, EIR, FSS, RTQ) for submission; maintaining ICH compliance, best practices & regulatory guidelines.• Critically reviewed & transcribed health agencies (AEMPS, AIFA, BSG, EMEA, FDA, IMB, MoH) questions in fast-pace GRP environment to support Calcium Carbonate, Diclofenac, Nicotine and Paracetamol product/franchise filings, and to assure accurate, appropriate and decisive responses. • Decisions on multiple complex projects with changing regulatory requirements and extreme timelines; enhancing product brand recognition and increasing revenue.

Assembled, content preparation and reviewed CMC-scientific-technical documents including: annual reports, justifications/rationale, registration renewals & supplements/variations. New emerging, regulatory strategy & worldwide high revenue markets.• Pioneered, project lead and strategized (short & long term) for the GMP document project (Taiwan FDA & Turkey MoH): reviewed, built global health agencies company team data-base & created efficient standard work-flow process.• Negotiated, persuaded, problem solved, innovatively influenced and made suggestions on multiple high profile-projected blockbuster ($ Billion) products as single contact point in extremely competitive business landscape and quick thinking GMP/GRP team environment ensuring accurate & 24-hour turnaround. • Collaborated with Product/Registration Managers on complex, highly sensitive, proprietary business information & network changes while meeting crucial regulatory conditions and short filing timelines. • Coordinated, managed, and translated legal document types: CAPA, CCS, DMF, EIR, FSS, RTQ, SMF, VMP, clean-air class & facility diagrams and manufacturing & materials flow process schematics in 5 different languages; lifecycle tracking of new development, post approval changes and product/product franchise.• Efficiently worked within matrix system of 50 internal and external manufacturing/packaging sites, executive committee, legal team, logistics & procurement, packaging technology and stability group. • eCTD-VDM assemblies in Documentum platform, product label, Project Management (PMD), Trackwise, and Quality Information (QSIS) provided to release sites worldwide; integrated existing, legacy & new internal client CMC document management systems.• Government (ASEAN-JP, EU-EP, US-USP, ROW) requirements for legal holds, National Pharmacopeia, Emerging Market Strategies, tender bids (manufacturing license, permission to inspect) and post-approval changes.

Kenilworth, Nj, Us

• Supported blockbuster ($Billion) IND/NDA immediate formulations cardiovascular prescription products in Oral Specialty Product Development.• Managed method development, sample preparation, pre-validation work, stability set-up and independent research to support high ranking GMP projects and investigational compounds. • Developed product line, completed vital evaluations and contributed to research procedures, technical reports, out of specification investigations (OOS) and stability studies of prescription products with accuracy and precision. Provided 24-hour turn-around for critical samples.• Validated Waters’ Empower dissolution analytical software in-line with HPLC run improving efficiency and productivity. Saved over $500,000 in annual licensing and maintenance fees.

Developed analytical methods for IND/NDA, consumer and commercial prescription products focused on immediate and time-release formulations of allergy, cns, cough-cold, muscle relaxants, nasal inhalers and ophthalmic drug applications. Developed CHP & SOP plans and protocols, managed laboratory compliance, safety and analytical equipment calibration in meeting GLP & cGMP.• Developed 21 analytical content uniformity, dissolution and potency methods analyzing single and multiple active pharmaceutical ingredients, excipients and preservatives in 6 weeks. • Developed Azelastine and Carisoprodol product-line franchise, improved taste formulation & compression evaluations, and developed test (cu/dissolution/potency) procedures and stability studies of low dose & extended release products. Provided 24’ turnaround for vital samples and projected to have $300M in sales.• Resolved manufacturing issues providing analytical support, manufacturing and precision studies vital for the release and distribution of Azelastine nasal and ophthalmic $450M product-lines.• Developed extractable & leachable assay methods - plasticizers, antioxidants, and other extractable analytes in HDPE bottle, components & nebulizer unit dose vial for Azelastine product line/franchise.; antioxidant characterization & determination in Plastic Packaging - Pittsburg Conference Feb 2007. • Developed E.L.I.S.A. prototype assay in launching new hs-CRP and Lyme diagnostic kits to market; CLIA-PMA waiver & validation. • Saved $95,000 annually on clinical, laboratory and safety supplies by setting up and establishing competitive pricing plan with vendors and wholesalers. IQ/OQ/PQ analytical/diagnostic hardware.• Saved $80,000 annually by negotiating, streamlining chemical and hazardous waste storage and disposal, while maintaining safety and adhering to federal & state governmental regulations.

Perform analytical evaluations, method development, transfer & validation and stability studies. Responsible for laboratory compliance, safety and calibration monitoring. Provide analytical support by developing analytical methods for investigative and commercial products in product & process development. Perform analyses to support clinical, research & stability studies. Develop, document, validate and transfer analytical & experimental procedures in a GMP environment. Performed analyses and independent research to support projects and investigational compounds. Organized and reviewed analytical data and verified laboratory notebooks and data packets. Developed SOP procedures and protocols required by GLP’s and GMP’s. Coordinated and resolved safety, health and environmental objectives and issues. Evaluated and recommended acquisition of new analytical equipment to improve efficiency and productivity.- Coordinate E.L.I.S.A. prototype assay development in preparation of launching new hsCRP kit to market.- Coordinate offsite clinical research studies; Involve in all key objectives for the Lyme kit CLIA. FDA. waiver and it's validation;

Princeton, Nj, Us

• Sterile techniques to prepare, label, and store both intravenous & oral medications for: controlled narcotics (epidurals & PCA.), prescription drugs, chemical reagents (Dakin’s), commercially unavailable investigational drugs, special formulation and compounding (PGE-gel), Hyperalimentation/TPN., and chemotherapeutic drugs in large teaching hospital. • Handling animal specimens (medical leeches). • Orientation, GMP, and GPP training of students & new personnel

New Brunswick, Nj, Us

• Aseptic techniques to make, package, store, and label both intravenous & oral prescription drugs, cancer chemotherapeutic agents, TPN./Hyperalimentation and controlled narcotics (CI-CV); • Supervised evening & weekend staff; Orientation, GMP and GPP training of new personnel. • Computer order entry, inventory control, purchasing and processing controlled narcotic & prescription drug orders to medical and pharmaceutical vendors & wholesale suppliers for the hospital systems

• Performed ELISA, ImmunoChemistry, Radioimmunoassay’s and Western Blot • Devised biochemical, biomedical & radioactive isotope assays and developed clinical & experimental assay procedures for endocrine (all hormones and Prostaglandins) and pharmacological parameters. • Handled, maintained and performed surgery on small, large, and research animals.• Organized & reviewed analytical data, verified laboratory notebooks and data packets for scientific publications.

Valhalla, Ny, Us

• Worked in pioneering, highly recognized and awarded (John C. McGiff) group for Arachidonic acid & Prostaglandin research. • Devised biochemical, biomedical & radioactive isotope assays and developed clinical & experimental assay procedures for endocrine (Eicosanoids and Prostaglandins) and pharmacological parameters. • Performed Cell based-Tissue BioAssay, ImmunoChemistry, Radioimmunoassay’s and Western Blot • Certified and trained in handling, maintaining, and performing surgery on small and research animals.• Organized and reviewed analytical data, verified laboratory notebooks and data packets.

Brooklyn, Ny, Us

My responsibilities include…

Bachelor'S Degree, Analytical Chemistry

West Graduate College