Dolores Baksh Email & Phone Number | As a biotechnology professional, I am motivated by a work environment that is dynamic and cross-functional. My strategic, technical and operational experience has been in the development of medical devices and biologics products. My professional and industry experience spans the value chain from R&D, process/product development, manufacturing to commercialization. Leadership – Effectively led new strategic initiatives in a dynamic and competitive market landscape to support the growth and expansion of business units. Management – Proven track record of concurrently managing multi-interdisciplinary R&D (Product, Process and Analytical Methods development) and Operations departments. Innovation – Foster a culture of innovation across the organization through the launch & maintenance of an Innovation Model, resulting in new patents, product pipeline expansion and published scientific abstracts and papers aligned with corporate vision. Technical Expertise – Direct experience with medical devices and biologics product development, following Design Control, ICH Guidelines (Quality By Design) and/or appropriate FDA CFRs. Skill-sets - Mammalian cell culture (adult and stem cells) • Cell and molecular biology, immunology • biomaterials (polymeric and calcium phosphates) • Product and process development activities • Allogeneic and autologous product/process development • Assay development • Process and assay tech transfer activities •CDRH and CBER FDA regulated environment • cGMP trained & certified • Risk assessment tools • Lean & 6 sigma (yellow belt) • FDA inspections, BLA preparation and maintenance, Post-marketing Commitments (PMCs) monitoring • Corporate due diligence activities • Corporate and scientific data preparation & presentation • Excellent written and verbal communication skills • Data analysis and report writing • Computer software experience: Design Expert, SPSS, Microsoft Office.

Dolores Baksh

As a biotechnology professional, I am motivated by a work environment that is dynamic and cross-func...
Boston, Massachusetts, United States

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Dolores Baksh’s Email dbaksh@cytiva.com

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Dolores Baksh’s Location Boston, Massachusetts, United States

Dolores Baksh’s Current Industry Cytiva

Dolores Baksh’s Prior Industry Vineti | Ge Healthcare | Organogenesis | National Institutes Of Health

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Work Experience

Cytiva

Global Solutions Marketing Leader - Cell Therapy

2020-06-01 00:00:00 - Present

Vineti

Vp Business & Commerical Development

2016-06-01 00:00:00 - 2017-03-01 00:00:00

Ge Healthcare

Innovation Leader, Cell & Gene Therapy Technologies

2014-08-01 00:00:00 - 2020-03-01 00:00:00

Organogenesis

Director, R&D

2010-12-01 00:00:00 - 2014-07-01 00:00:00

National Institutes Of Health

Translational Research - Postdoctoral Fellow

2004-02-01 00:00:00 - 2007-02-01 00:00:00

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FAQ About Dolores Baksh

Dolores Baksh is located at
Boston, Massachusetts, United States

Dolores Baksh is a As a biotechnology professional, I am motivated by a work environment that is dynamic and cross-functional. My strategic, technical and operational experience has been in the development of medical devices and biologics products. My professional and industry experience spans the value chain from R&D, process/product development, manufacturing to commercialization. Leadership – Effectively led new strategic initiatives in a dynamic and competitive market landscape to support the growth and expansion of business units. Management – Proven track record of concurrently managing multi-interdisciplinary R&D (Product, Process and Analytical Methods development) and Operations departments. Innovation – Foster a culture of innovation across the organization through the launch & maintenance of an Innovation Model, resulting in new patents, product pipeline expansion and published scientific abstracts and papers aligned with corporate vision. Technical Expertise – Direct experience with medical devices and biologics product development, following Design Control, ICH Guidelines (Quality By Design) and/or appropriate FDA CFRs. Skill-sets - Mammalian cell culture (adult and stem cells) • Cell and molecular biology, immunology • biomaterials (polymeric and calcium phosphates) • Product and process development activities • Allogeneic and autologous product/process development • Assay development • Process and assay tech transfer activities •CDRH and CBER FDA regulated environment • cGMP trained & certified • Risk assessment tools • Lean & 6 sigma (yellow belt) • FDA inspections, BLA preparation and maintenance, Post-marketing Commitments (PMCs) monitoring • Corporate due diligence activities • Corporate and scientific data preparation & presentation • Excellent written and verbal communication skills • Data analysis and report writing • Computer software experience: Design Expert, SPSS, Microsoft Office.