Jette Wagtberg Sen
Chief Operating Officer at Synklino- Claim this Profile
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English Full professional proficiency
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Turkish Elementary proficiency
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Danish Native or bilingual proficiency
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Bio
Kirsten Drejer
As the CEO of Symphogen I had the pleasure of watching how Jette Wagtberg Zen was able to transform her in-depth protein analytical chemistry knowledge from a succesful academic career into focused and applied, yet cutting edge, science in pioneering drug development products, all protein based. Throughout the years at Symphogen, Jette has been a hard-working, dedicated and insightful employee/leader and demonstrated the ability to generate pivotal information on projects which were described as 'mission impossible' by outsiders. Jette has the will to go the extra mile, when needed. In addition, Jette has developed excellent managerial skills, with the ability to lead and achieve results in cross-functional teams. She is a good team-player in leadership teams with her peers. She is excellent at setting the right strategic direction for complex projects and always go for ambitious goals. Her communication skills are excellent and her communication style is open, direct and to the point, while still with a human touch and a sense of humor. She is a highly recognized presenter at scientific business meetings (internal, external business meetings and at conferences), and has demonstrated outstanding skills in establishing good and efficient relations to international colleagues at companies with shared drug development projects. Jette is a 'second to none catch' for organizations looking for senior CMC drug development leadership skills including overall strategic guidance.
Lise Smith Sørensen
Jette has a strong scientific background in protein chemistry, analytical characterization and development which in combination with an extraordinary strategic mindset, sense of business and her direct and assertive communication style makes her an excellent leader within biopharmaceutical CMC development. I have had Jette as my direct manager for 3 years at Symphogen, both when I was scientist and team manager; she always gave me honest feedback and was genuinely interested in my growth and development as a new leader. Jette is one of the best managers I have had in my career, as she both challenged and supported me in the best way. I will with joy remember our collaboration on the regulatory strategy for the late phase product at Symphogen – a hectic time with many regulatory submissions and health authority meetings; here Jette was the key driver with respect to setting the characterization and control strategy for the product.
Kirsten Drejer
As the CEO of Symphogen I had the pleasure of watching how Jette Wagtberg Zen was able to transform her in-depth protein analytical chemistry knowledge from a succesful academic career into focused and applied, yet cutting edge, science in pioneering drug development products, all protein based. Throughout the years at Symphogen, Jette has been a hard-working, dedicated and insightful employee/leader and demonstrated the ability to generate pivotal information on projects which were described as 'mission impossible' by outsiders. Jette has the will to go the extra mile, when needed. In addition, Jette has developed excellent managerial skills, with the ability to lead and achieve results in cross-functional teams. She is a good team-player in leadership teams with her peers. She is excellent at setting the right strategic direction for complex projects and always go for ambitious goals. Her communication skills are excellent and her communication style is open, direct and to the point, while still with a human touch and a sense of humor. She is a highly recognized presenter at scientific business meetings (internal, external business meetings and at conferences), and has demonstrated outstanding skills in establishing good and efficient relations to international colleagues at companies with shared drug development projects. Jette is a 'second to none catch' for organizations looking for senior CMC drug development leadership skills including overall strategic guidance.
Lise Smith Sørensen
Jette has a strong scientific background in protein chemistry, analytical characterization and development which in combination with an extraordinary strategic mindset, sense of business and her direct and assertive communication style makes her an excellent leader within biopharmaceutical CMC development. I have had Jette as my direct manager for 3 years at Symphogen, both when I was scientist and team manager; she always gave me honest feedback and was genuinely interested in my growth and development as a new leader. Jette is one of the best managers I have had in my career, as she both challenged and supported me in the best way. I will with joy remember our collaboration on the regulatory strategy for the late phase product at Symphogen – a hectic time with many regulatory submissions and health authority meetings; here Jette was the key driver with respect to setting the characterization and control strategy for the product.
Kirsten Drejer
As the CEO of Symphogen I had the pleasure of watching how Jette Wagtberg Zen was able to transform her in-depth protein analytical chemistry knowledge from a succesful academic career into focused and applied, yet cutting edge, science in pioneering drug development products, all protein based. Throughout the years at Symphogen, Jette has been a hard-working, dedicated and insightful employee/leader and demonstrated the ability to generate pivotal information on projects which were described as 'mission impossible' by outsiders. Jette has the will to go the extra mile, when needed. In addition, Jette has developed excellent managerial skills, with the ability to lead and achieve results in cross-functional teams. She is a good team-player in leadership teams with her peers. She is excellent at setting the right strategic direction for complex projects and always go for ambitious goals. Her communication skills are excellent and her communication style is open, direct and to the point, while still with a human touch and a sense of humor. She is a highly recognized presenter at scientific business meetings (internal, external business meetings and at conferences), and has demonstrated outstanding skills in establishing good and efficient relations to international colleagues at companies with shared drug development projects. Jette is a 'second to none catch' for organizations looking for senior CMC drug development leadership skills including overall strategic guidance.
Lise Smith Sørensen
Jette has a strong scientific background in protein chemistry, analytical characterization and development which in combination with an extraordinary strategic mindset, sense of business and her direct and assertive communication style makes her an excellent leader within biopharmaceutical CMC development. I have had Jette as my direct manager for 3 years at Symphogen, both when I was scientist and team manager; she always gave me honest feedback and was genuinely interested in my growth and development as a new leader. Jette is one of the best managers I have had in my career, as she both challenged and supported me in the best way. I will with joy remember our collaboration on the regulatory strategy for the late phase product at Symphogen – a hectic time with many regulatory submissions and health authority meetings; here Jette was the key driver with respect to setting the characterization and control strategy for the product.
Kirsten Drejer
As the CEO of Symphogen I had the pleasure of watching how Jette Wagtberg Zen was able to transform her in-depth protein analytical chemistry knowledge from a succesful academic career into focused and applied, yet cutting edge, science in pioneering drug development products, all protein based. Throughout the years at Symphogen, Jette has been a hard-working, dedicated and insightful employee/leader and demonstrated the ability to generate pivotal information on projects which were described as 'mission impossible' by outsiders. Jette has the will to go the extra mile, when needed. In addition, Jette has developed excellent managerial skills, with the ability to lead and achieve results in cross-functional teams. She is a good team-player in leadership teams with her peers. She is excellent at setting the right strategic direction for complex projects and always go for ambitious goals. Her communication skills are excellent and her communication style is open, direct and to the point, while still with a human touch and a sense of humor. She is a highly recognized presenter at scientific business meetings (internal, external business meetings and at conferences), and has demonstrated outstanding skills in establishing good and efficient relations to international colleagues at companies with shared drug development projects. Jette is a 'second to none catch' for organizations looking for senior CMC drug development leadership skills including overall strategic guidance.
Lise Smith Sørensen
Jette has a strong scientific background in protein chemistry, analytical characterization and development which in combination with an extraordinary strategic mindset, sense of business and her direct and assertive communication style makes her an excellent leader within biopharmaceutical CMC development. I have had Jette as my direct manager for 3 years at Symphogen, both when I was scientist and team manager; she always gave me honest feedback and was genuinely interested in my growth and development as a new leader. Jette is one of the best managers I have had in my career, as she both challenged and supported me in the best way. I will with joy remember our collaboration on the regulatory strategy for the late phase product at Symphogen – a hectic time with many regulatory submissions and health authority meetings; here Jette was the key driver with respect to setting the characterization and control strategy for the product.
Experience
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Synklino
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Denmark
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Biotechnology Research
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1 - 100 Employee
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Chief Operating Officer
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Sep 2019 - Present
Responsible for general company operations and R&D governance and development of portfolio strategy, Head of CMC. Responsible for general company operations and R&D governance and development of portfolio strategy, Head of CMC.
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JWSEN
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Copenhagen Area, Capital Region, Denmark
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Independent Consultant
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Mar 2019 - Present
Supporting biopharma companies and start-ups with general development strategy, operations, CMC, business development and transition from discovery to development. Supporting biopharma companies and start-ups with general development strategy, operations, CMC, business development and transition from discovery to development.
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Symphogen
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Denmark
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Biotechnology Research
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100 - 200 Employee
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Senior Director of Analytics and Formulation
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Nov 2018 - Jun 2019
Vision and leadership for analytical development and formulation development. Organizational tactical leadership as part of operational management team.Key responsibilities • Leadership development for principal specialists and team leaders, project leaders within drug product and analytical development • Regulatory interactions, documentation and face-to-face interactions (FDA, PEI, Swedish MPA, and DMA)• Overall CMC strategy and cross functional strategic portfolio management • Collaboration and support to business development; positioning of platform, due diligence, development scenarios, and budgetsKey achievements• Developed portfolio system and implemented processes to allow for optimal use of CMC resources and competences. Enabled scenario modelling to support sophisticated analyses of overall CMC development strategy options, optimizing timing of financial commitments and deliverables in terms of key value drivers across projects. • Part of cross functional team establishing overall process validation strategy for drug substance and drug product. Headed the regulatory consolidation of strategy for validation activities within analytical, formulation and stability for a fixed combination product. Regulatory alignment, comparability, briefing packages, regulatory discussions, and face to face meetings with FDA, PEI, Swedish and Danish Health authorities. Show less
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Director of Analytical Development
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Jun 2013 - Nov 2018
Vision and leadership for analytical development and formulation development. Definition of phase appropriate development strategy for monoclonal and fixed combination projects from research and preclinical to phase 3, covering a portfolio of 14 monoclonal antibodies.Key responsibilities• Leadership for the department (20+), development of technical and scientific platform within analytical and formulation development• Leadership for analytical project leaders and drug product project leaders on development projects from preclinical to phase 3 readiness• Overall cross functional CMC strategy on development projects in collaboration with head of process development and CMC project directors• Regulatory interactions, documentation and face-to-face interactions (FDA, PEI, and DMA)• Collaboration and support to business development; positioning of platform, due diligence, development scenarios, and budgetsKey achievements• Developed the analytical and pharmaceutical development CMC organization to be highly competitive in timelines, capacity and scientific excellence. Implementation of new organizational structure in CMC, leading to higher efficiency and consolidated cross functional development strategy, supporting well informed strategic level decisions.• Development of “18 months from lead to IND” development plan, based on the platform. Used for internal projects as well as partnered projects. Now a key asset for Symphogen and instrumental in a $175 million upfront deal with Baxalta in 2015. Lead on the overall project plan and budget for the deal.• Identification and implementation of new technologies to support development of fixed combination drug products. Establishment of strategic partnerships. Show less
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Team Manager
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Apr 2012 - Jun 2013
Daily operational management of a team of technicians and scientist working on activities within analytical development, analytical support, characterization, formulation development, and development of downstream manufacturing processes. Analytical project management of internal development activities, as well as outsourced GMP analytical activities. Implementation of formalized developability assessment as part of overall lead selection strategy.
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Senior Scientist
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Feb 2009 - Apr 2012
Physicochemical characterization, comparability studies, analytical development, analytical validation, technology transfer, regulatory filings, CMC development, LC-MS, HPLC, ELISA,
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Scientist
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Feb 2008 - Feb 2009
Establishment of LC-MS facility, analytical development, physicochemical characterization
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Rigshospitalet
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Hospitals and Health Care
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700 & Above Employee
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post.doc
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Feb 2003 - Nov 2006
Biomarkers, analytical protein chemistry, HPLC and LC-MS Biomarkers, analytical protein chemistry, HPLC and LC-MS
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Syddansk Universitet - University of Southern Denmark
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Denmark
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Higher Education
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700 & Above Employee
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PHD
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1999 - 2002
Establishment of LC-MS core facility, development of biomarkers. Establishment of LC-MS core facility, development of biomarkers.
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Mayo Clinic
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United States
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Hospitals and Health Care
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700 & Above Employee
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visiting ph.d. student
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Sep 2000 - May 2001
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Education
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1999 - 2002
University of Southern Denmark
ph.d., molecular biology (protein chemistry/mass spectrometry) -
2016 - 2017
Stifinder - Leadership training and development
Stifinder, Module 1-3 -
1992 - 1999
Københavns Universitet - University of Copenhagen
cand.scient. /master, biochemistry, proteinchemistry -
Maribo Gymnasium
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