• Strategic plan to include Japan in global clinical trials aiming simultaneous submissions with all major markets (US, EU, JP). Review of documents for US, EU and plans for regulation and quality gaps mitigation for Japan.
• Scouting for partnerships in Japan

2012 - 2014: Define strategies and overseeing governance processes for a portfolio of branded and generic products pipeline

Role: SENIOR DIRECTOR OF PRODUCT DEVELOPMENT AND MARKET PORTFOLIO LIAISON, JAPAN

Customer: TEVA PHARMACEUTICALS LTD., GLOBAL GENERIC AND BRANDED R&D, PETACH TIQUA - IL

Tasks:

Define strategies and overseeing governance processes for a portfolio of branded and generic products pipeline, of in-house and CMO?s clinical and CMC development programs for the Japanese market. Responsibilities included:

BRANDED PORTFOLIO

• Supervising a branded pipeline of ca. 10 projects of small molecules and biologics in different TA?S.; oversight of matrix R&D functions (clinical, CMC of the API and formulations, commercial, and regulatory) to implement global clinical trials and facilitate PMDA consultations for the products in the pipeline (pain, respiratory and CNS).
• Orchestrating cross-functional, global matrix teams for the development of branded drug of TA candidates for CNS, multiple sclerosis, respiratory, inflammation, and pain in Japan.

GENERIC PORTFOLIO

• Defining generic program success criteria?s; assessing gaps and opportunities against milestones and patents noninfringements strategies, and enabling cost- and resource-saving mitigation plans to deliver development and quality milestones of a GR&D workplan.
• Building a generic oncology portfolio (e.g. paclitaxel, carboplatin, cytarabine injections etc.). Assessment of methods of production and analytical documents, driving executions in multiple R&D sites of Nagoya, Mumbai, Teva Gödöllö HU, Rancorn UL, Haarlem HL and others to execute on time pivotal lots production, stability programs, technology transfer, bioequivalence studies and validation.
• Set up governances work-plan processes to establish sound portfolio with at least 90 % projects commitments, budget adherence and submission files risk assessment.

2010 - 2011: Supervising integration activities of post M&A

Role: CORPORATE DIRECTOR AND DEPUTY HEAD OF R&D

Customer: TEVA-KOWA PHARMA CO. LTD. TOKYO, JAPAN

Tasks:

• Supervising integration activities of post M&A (Taiyo Yakuhin, Teva-kowa) to a streamlined R&D unit of Teva Seiyaku.
• Set-up streamlined processes of generic development projects in Teva-Kowa JV, mainly in Teva?s oversee sites and fee-for-service projects of contract development.
• Establishment, in Mumbai India, a cost effective IND production and primary packaging center, dedicated for developing intermediate release OSD's for submission in Japan.
• Supervision of four (4) quality control laboratories (cGMP testing and analytical qualification/validation, stability programs) as part as quality remediation program (Taiyo).
• Designed and established cost-effective stability program center QC Laboratory that performed stability testing under ICH testing condition

Role: HEAD OF DEVELOPMENT OF TEVA-KOWA (TK) AND TK BOARD MEMBER

Customer: TEVA-KOWA PHARMA CO. LTD. TOKYO, JAPAN

Tasks:

• Streamlined millstones of generic of development for Teva-Kowa KK JV in Tokyo; Oversee Teva R&D sites for Japan and associated contract development CMO?s in India and Taiwan.
• Compliance due diligence audit of a the R&D as part of the M&A by Teva-Kowa JV of a domestic company (Taisho Yakuhin Kogyou (TYK)) (Dec. 2009).
• Training programs of regulation for drug products and API?s in Japan and maintaining an education program for Teva R&D sites, in charged with development projects for Japan

2007 - 2009: Documentation review, portfolio and back-end activities

Role: DIRECTOR, JAPAN R&D

Customer: on request

Tasks:

• Oversight of CMC and bioequivalence activities across the various Teva R&D and production sites (Haarlem HL, Kfar-Saba IL, Irvine CA and CMO?s) up to submission by Teva's subsidiary in Tokyo (TevaKK).
• Documentation review, portfolio and back-end activities to and support of the establishment of Teva-Kowa Pharma Joint venture in Japan.

2002- 2007: Analytical testing of launched products

Role: HEAD OF QUALITY CONTROL UNIT

Customer: TEVA PHARMACEUTICAL LTD. IL OPERATIONS DIVISION, KFAR-SABA - ISRAEL

Tasks:

• Operation of 5 QC laboratories to performed cGMP analytical testing of in-process control, lot release, stability testing, method remediation with a headcount of 250 FTE?s applying all array of analytical equipment?s.
• Applying Labware and SQL LIMS, Trackwise, Empower CDS, Agilent Openlab, Documentum etc.
• Supervised analytical testing for release of over 9 billion tablets in addition to sterile, otic and ophthalmic drug products for all major markets.
• Analytical testing of launched products, process validation and supervising the analytical releases of the three (3) worldwide biggest generic launches of 2006 (Pravastatin USP, Simvastatin USP and Sertraline USP).
• Construction of 3 laboratories in various sites for QC lot release and stability testing.
• Multiple regulatory inspections at of FDA, EMA, MHRA, PMDA and ANVISA.
• Introduction of process analytical technology PAT methodologies of non-destructive rapid detection methods to the QC (NIR) and execution of operational excellence team, to develop and implement alternative robotic highthroughput for Uniformity of Content, dissolution robot, while improving quality and saving manpower and redundant testing.

1999 - 2001: Management of a cGMP QC and R&D Laboratory to perform cGMP in-process

Role: HEAD OF QUALITY CONTROL AND ANALYTICAL DEVELOPMENT

Customer: SAM-ON LTD (MEDITECH) BAT-YAM, ISRAEL

Tasks:

• Management of a cGMP QC and R&D Laboratory to perform cGMP in-process, lot release, stability program and analytical method development of a staff more than 20 FTE's.
• Ensure the company recovery from various products domestic recalls due to microbiological contamination and changing major parts of the testing procedures, including the quality and documentation system

1999 - 1999: Preparation and conducting an OECD GLP accreditation Audit.

Role: LABORATORY OPERATION COO

Customer: AMINOLAB LTD. ANALYTICAL LABORATORY SERVICES, REHOVOT, ISRAEL

Tasks:

• Operation of an ISRAC accredited service laboratory, in the areas e.g.: environmental chemistry and pesticide residues, amino acid and aflatoxin analyses, microbiology testing of food, water, cosmetics and medical devices, GxP oriented contact analytical method developments and validations for pharmaceutical clients.

Role: HEAD OF QUALITY CONTROL UNIT

Customer: CTS INDUSTRIES, LTD. KIRIAT MALAHI, ISRAEL

Tasks:

• Management of cGMP QC laboratory for cGMP in-process, lot release, and stability testing, of 25 FTE?s to supported process validation, investigations, site audits and passed successfully numerous IL Ministry of health audits.
• Applying legacy wet chemistry method remediation plan by developing and validating conventional HPLC separation methods, and registration and approved by the IL MOH.

1993 ? 1996: Development and validation of stability indicating

Role: HEAD OF QUALITY CONTROL UNIT

Customer: TARO PHARMACEUTICAL INDUSTRIES LTD. HAIFA BAY, ISRAEL

Tasks:

• Successful first FDA pre-approval inspection of the US authorities in the site in Israel, 1995
• Development and validation of stability indicating, forced degradation studies of HPLC and GC analytical methods for pharmaceutical formulations (OSD, liquids, semi-liquids, powders etc.)