Robert Carter work email
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Robert Carter personal email
• A highly experienced and motivated manager with a very broad experience in many aspects of pharmaceutical development, regulatory affairs (CMC), quality, business development / sales, production and third party management• Excellent interpersonal and communication skills• Broad experience in Drug Substance and Drug Product quality assurance• Documented ability to successfully file CMC part of regulatory file• Demonstrated successful negotiation skills• Proven leadership of product transfers• Solid academic credentials, result-oriented, self-motivated • English and French both mother tongues, fluent GermanSpecialties: Drug substance and product Development, CMC regulatory, Management of TPM, GMP and quality of DS and DP, Business development
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Head Development And RegulatoryEpipharm Ag May 2012 - PresentBinningen (Basel Area, Switzerland)In charge of development, regulatory and quality at EpiPharm AGMember of the board of directors -
Senior Cmc ExpertAcino Pharma Ag Dec 2009 - Jun 2012 -
ConsultantEpipharm 2007 - 2010
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Head CmcArpida Jul 2007 - Nov 2009• CMC / Regulatory / Quality- Authored the full CMC file for one anti-infective sterile drug product to successful filing to both the FDA and the EMEA including meetings with the EMEA rapporteurs- Authored annual reports and IMPDs for ARPIDA development products - Contributed to, reviewed and approved validation documents for active pharmaceutical ingredient production, and for a terminally sterilized drug product - In charge of all quality aspects of product development, manufacturing and analysis• Management and selection of Third Party Manufacturers- Audited, selected and supervised contract laboratories and manufacturers- Negotiated, wrote up and implemented quality agreements and supply agreements• GMP audits- Co - hosted 2 FDA pre approval inspections at a contract lab and a contract manufacturer, participated in one sponsor audit, all three audits without any 483 observation- Instrumental to bringing 1 contract analytical laboratory to FDA standards -
Head Development And Product ManagementAbbott Laboratories 2001 - 2007• Member of the site management team - Site representative at corporate strategic production meetings - Emergency services manager for chemical incidents or disasters• Business development manager for the Liestal production site- Developed contract manufacturing concept for the site- Performed 4 due diligences, one of them led to a 300 Mio $ successful transaction- Successfully negotiated and led the transfer of an anti - retroviral API to the Liestal site• Quality / Regulatory- Responsible for regulatory affairs for the Liestal site (over 10 DMF)- In charge of the in-process lab and in-process analyses - Co - hosted 2 FDA pre approval inspections, many customer audits, all passed without major observations (FDA inspections without any observation)- Lead auditor / auditor for raw material suppliers and TPM (one on behalf of the WHO)- Reviewed and approved all production master batch records for changes -
Head Development And Product ManagementKnoll / Basf Pharma 1988 - 2001Liestal Switzerland• Business development manager for the Liestal production site- Developed contract manufacturing concept for the site- In charge of internationalization of L-Thyroxine tablets to the US and Asia - Assessed and negotiated over 10 contract manufacturing opportunities- Studied the market for generic active pharmaceutical ingredients and defined the development concept for global BASF Pharma.- Site representative on the BASF Pharma global generic and production teams• Quality;- Validation manager for API production and cleaning - In charge of In process lab and analytical validation- Supplier auditor• Development- Developed, optimized and / or scaled-up production processes for over 20 pharmaceutical active substances or intermediates- Developed and implemented a novel process optimization concept for the site- Co - designed a GMP kilo lab to for the whole BASF Pharma group- Led a team of 8 persons and numerous project specific teams- Recruited, supervised, motivated and evaluated employees of the unit• Production manager and deputy head of production- Led for 6 months one active pharmaceutical ingredient plant (> 80 t/year production)- Led the GMP kilolab production - Deputy Head of Production for 5 years• Sales manager for APIs for all of BASF Pharma in Switzerland- Increased sales twentyfold • Responsible for strategic purchasing- Identified and selected supplier of key raw materials, co - negotiated prices / terms
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Licensing ManagerCiba-Geigy 1986 - 1988• Assessed scientific, medical, technical and commercial value of in - licensing product candidates for the pharma international division.• Analyzed commercial product lines, identified gaps, searched for licensing opportunities• Negotiated licensing agreements -
Project Leader Novel Dosage FormsCiba-Geigy 1983 - 1986In charge of all new CIBA-GEIGY/ALZA projects in the area of novel dosage forms (transdermal, OROS, bucal).• Coordinated activities in Formulation Development, Pharmaceutical Chemistry, Clinical Development. Licensing and Central Product Management for novel dosage forms• Planned and executed new project concepts• Assessed all suggestions for novel formulations from internal and licensing sources• Successfully generated the Nicotinell TTS project concept -
Development ChemistCiba-Geigy 1980 - 1983Optimized and scaled up of chemical production processes including a process for the production of a pigment intermediate in 1000 ton/year scale
Robert Carter Skills
Robert Carter Education Details
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Chemistry, Biochemical Engineering -
Athénée De Luxembourg
Frequently Asked Questions about Robert Carter
What company does Robert Carter work for?
Robert Carter works for Epipharm Ag
What is Robert Carter's role at the current company?
Robert Carter's current role is Head of Development at EpiPharm.
What is Robert Carter's email address?
Robert Carter's email address is ro****@****rma.com
What schools did Robert Carter attend?
Robert Carter attended Eth Zürich, Athénée De Luxembourg.
What skills is Robert Carter known for?
Robert Carter has skills like Business Development, Gmp, Regulatory Affairs, Fda, Pharmaceutics, Product Development, Pharmaceutical Industry, Biotechnology, Validation, Cross Functional Team Leadership, Generic Programming, Contract Manufacturing.
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Robert Carter
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