Ike James
Head of Technology Transfer at Medicines Patent Pool- Claim this Profile
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Bio
Ruben Nijs
Ike is one of the most professional, driven and knowledgeable partners I have ever had the pleasure to work with. We collaborated on an incredibly challenging project and he played a pivotal role in its success. On top a real teamplayer and wonderful to work with.
Francois van Brakel, B.Pharm, MBA
Had the privilege of working under Ike James Technical Manager of the Tech Transfer/MSAT Aseptic Manufacturing department at Aspen South Africa. Ike successfully lead the largest Anaesthetic and Thrombosis Portfolio expansion project ever recorded in the southern hemisphere with a total of 800+ global SKU's Apart from Ike's strong leadership and negotiating skills, Ike was instrumental in influencing key stakeholders in meeting critical project timelines. Despite Covid19 and organisational change challenges, Ike was able to show agility and resilience under pressure. Ike earns my highest recommendation.
Ruben Nijs
Ike is one of the most professional, driven and knowledgeable partners I have ever had the pleasure to work with. We collaborated on an incredibly challenging project and he played a pivotal role in its success. On top a real teamplayer and wonderful to work with.
Francois van Brakel, B.Pharm, MBA
Had the privilege of working under Ike James Technical Manager of the Tech Transfer/MSAT Aseptic Manufacturing department at Aspen South Africa. Ike successfully lead the largest Anaesthetic and Thrombosis Portfolio expansion project ever recorded in the southern hemisphere with a total of 800+ global SKU's Apart from Ike's strong leadership and negotiating skills, Ike was instrumental in influencing key stakeholders in meeting critical project timelines. Despite Covid19 and organisational change challenges, Ike was able to show agility and resilience under pressure. Ike earns my highest recommendation.
Ruben Nijs
Ike is one of the most professional, driven and knowledgeable partners I have ever had the pleasure to work with. We collaborated on an incredibly challenging project and he played a pivotal role in its success. On top a real teamplayer and wonderful to work with.
Francois van Brakel, B.Pharm, MBA
Had the privilege of working under Ike James Technical Manager of the Tech Transfer/MSAT Aseptic Manufacturing department at Aspen South Africa. Ike successfully lead the largest Anaesthetic and Thrombosis Portfolio expansion project ever recorded in the southern hemisphere with a total of 800+ global SKU's Apart from Ike's strong leadership and negotiating skills, Ike was instrumental in influencing key stakeholders in meeting critical project timelines. Despite Covid19 and organisational change challenges, Ike was able to show agility and resilience under pressure. Ike earns my highest recommendation.
Ruben Nijs
Ike is one of the most professional, driven and knowledgeable partners I have ever had the pleasure to work with. We collaborated on an incredibly challenging project and he played a pivotal role in its success. On top a real teamplayer and wonderful to work with.
Francois van Brakel, B.Pharm, MBA
Had the privilege of working under Ike James Technical Manager of the Tech Transfer/MSAT Aseptic Manufacturing department at Aspen South Africa. Ike successfully lead the largest Anaesthetic and Thrombosis Portfolio expansion project ever recorded in the southern hemisphere with a total of 800+ global SKU's Apart from Ike's strong leadership and negotiating skills, Ike was instrumental in influencing key stakeholders in meeting critical project timelines. Despite Covid19 and organisational change challenges, Ike was able to show agility and resilience under pressure. Ike earns my highest recommendation.
Experience
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Medicines Patent Pool
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Switzerland
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Non-profit Organizations
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1 - 100 Employee
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Head of Technology Transfer
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Mar 2022 - Present
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Lonza
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Switzerland
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Pharmaceutical Manufacturing
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700 & Above Employee
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Senior Technology Transfer Lead
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Apr 2021 - Mar 2022
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Aspen Pharma Group
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South Africa
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Pharmaceutical Manufacturing
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700 & Above Employee
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SVP Technical Manager
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Jan 2018 - Mar 2021
Leadership and Technical contributiono Experience in leading key activities involved in R&D, technology transfer and commercial launch of various products: Sterile liquids, emulsions, lyo, vials, ampoules, pre-filled syringes, cartridges, bottles.o Continuous review of new opportunities ensuring a competitive and healthy product pipeline.o Visionary leadership and coordination of new and scalable processes and analytical techniques in accordance with current international scientific cGMP and pharmaceutical manufacturing standards.o Effective management & collaboration with stakeholders to drive and define project potential, scope and focus, ensuring aligned direction on priorities.o Establishing multidisciplinary synergies and forward thinking approaches towards the design, development, technology transfer and commercial launch of different cost-attractive technologies and products.o Continuous macro environment, and industry analysis ensuring the sustained and solid understanding of emerging technologies to maintain the company at the forefront of new developments and opportunities.o Managing capital and operating budgets, ensuring accurate forecasting versus spend.o Continuous development and mentoring of teams ensuring teamwork, high performance and critical skill development & retention.o Technical expertise includes API manufacturing, formulation, filling, inspection and packaging.o Experience in working with leading pharma companies in USA, Europe, Central America, East, Far East and Africa catering to various quality and regulatory requirements.o Technology transfer experience includes both inward/ outward bound technology packages.PV, CI and commercial launch experience of products meeting FDA, TGA, ANVISA, BfArM, WHO, MENA, JPN, and ChP requirements.o Key strengths: Strategic and proactive thinking, listening & communication, collaborating, influencing, driving targets, processing information, and simplifying complex matters. Show less
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New Products Transfer Manager
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Aug 2017 - Jan 2018
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Biovac
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South Africa
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Pharmaceutical Manufacturing
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300 - 400 Employee
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Science and Innovation Group Leader
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Sep 2014 - Jul 2017
Technical contributiono Chemical engineer with 15 years of leadership and technical experience in the development and technology transfer of various vaccines and biopharmaceuticals.o Technical expertise includes API manufacturing, formulation and filling and viewing, labeling and packaging.o Experience in working with leading pharmaceutical companies worldwide including USA, Europe, Central America, The East, and Africa catering to various quality and regulatory requirements.o Product and process development experience includes API processes with a key focus on fermentation technologies.o Technology transfer experience includes both inward and outward bound technology packages and activities.o Comprehensive expertise in equipment & facility qualifications, scale-down & scale-up, including standardization of operations.o Skilled in planning and leading continual improvement programs for enhancing yield & quality of products, reducing costs and boosting productivity & performance.Leadership contributiono Effective project management ensuring project delivery in relation to cost, time & quality.o Management of team activities to achieve company objectives.o Visionary leadership and coordination of new and scalable processes in accordance with cGMP and pharmaceutical manufacturing standards.o Collaboration with stakeholders to drive and define project potential, scope & focus, ensuring aligned direction on priorities for new products.o Establishing multidisciplinary synergies and forward thinking approaches towards the design, development, optimisation, technology transfer and scale up of different cost-attractive vaccine technologies.o Continuous review of business strategies and new business opportunities ensuring a competitive product pipeline.o Identification of new product development projects and business case development.o Effective management and directive ensuring introduction of new products in alignment with the business’s strategic intent. Show less
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Acting Product Development Group Leader: Upstream (Chem Eng., PhD)
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Mar 2014 - Aug 2014
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Product Development Technology Platform Leader (Chem. Eng., PhD)
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Aug 2013 - Feb 2014
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Senior Scientist (Chem. Eng., PhD)
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Aug 2009 - Jul 2013
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Council for Scientific and Industrial Research (CSIR)
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South Africa
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Research
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700 & Above Employee
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Bioprocess Engineer (PhD candidate)
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Aug 2006 - Aug 2009
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Education
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Stellenbosch University/Universiteit Stellenbosch
Doctor of Philosophy - PhD, Chemical Engineering -
Durban High School