Mandakini (Mandy) Sharma Email and Phone Number
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• Creative and energetic leader with 20 years of experience in Process Development-Technical Operations, Quality Control and Program Management for global big pharma, CDMOs and biosimilar upstarts• Expertise in leading culturally diverse, cross functional teams supporting drug development and CMC strategy from early to late stage clinical products• Experience with directly managing teams, in Asia and US, of Process Scientists supporting in-house innovation, as well as technology transfer projects for contract manufacturing business• Hands-on experience in the design and execution of process characterization and validation studies, including the implementation of QbD tools. Lead author on multiple regulatory submissions for biologics• Strong managerial, communication and interpersonal skills with proven track record through awards and recognition on effectively engaging with senior leadership and external partners • Leading the implementation of Project Management tools within the Quality division to support strategic capacity planning, new project evaluations and vendor management• Active participant in leadership initiatives and invitee to multiple mentoring panel events in science and technology in the Bay Area and India
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Senior Cmc ConsultantCalifornia, United States
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Head Of Biologics Cmc Program ManagementExelixis Jul 2023 - PresentAlameda, California, Us -
Head Of Project ManagementLonza Jan 2021 - Jul 2023Basel, Ch -
Head Of Project Management, Quality ControlBoehringer Ingelheim Feb 2019 - Jan 2021Ingelheim Am Rhein, Rhineland-Palatinate, De -
Cmc Project Leader, Associate DirectorBoehringer Ingelheim Oct 2016 - Jan 2019Ingelheim Am Rhein, Rhineland-Palatinate, De -
Associate Director- Process ScienceBoehringer Ingelheim Dec 2014 - Sep 2016Ingelheim Am Rhein, Rhineland-Palatinate, DeManaged a team of scientists and senior scientists responsible for small-scale development and pilot scale operations including GMP manufacturing.Purification lead for multiple early and late stage monoclonal antibody products. Worked with cross-functional teams to support IND and BLA filings. Support Process Validation Campaigns, working with cross-functional teams. Authored BLA sections and supporting documents for global submissions.Participated in the development of global guidance documents and training materials working with CMC strategy, cross-functional teams across multiple BI sites on Control Strategy, Risk Assessment & Process Characterization. -
Senior Scientific ManagerBiocon Jul 2012 - Aug 2014Bangalore, Karnataka, InCMC lead for partner project, Manage the Late Stage Pocess Development downstream lab, Lead for Process Characterization and Validation for multiple projects. -
Sra, Purification Scientist, Process DevelopmentGenentech Jun 2004 - May 2012South San Francisco, California, Us -
Research AssociateStanford University Dec 2003 - Jun 2004Stanford, Ca, UsStem Cell Research -
Graduate Student ResearcherRutgers Robert Wood Johnson Medical School May 2001 - Sep 2003New Brunswick, Nj , Us -
Research FellowPenn State University Aug 2000 - May 2001University Park, Pa, UsAs PhD Candidate worked on Gene Silencing
Mandakini (Mandy) Sharma Skills
Mandakini (Mandy) Sharma Education Details
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Rutgers UniversityGenetics -
Pennsylvania State University College Of MedicineGenetics -
Indian Institute Of Technology, BombayBiotechnology -
Aps Delhi
Frequently Asked Questions about Mandakini (Mandy) Sharma
What company does Mandakini (Mandy) Sharma work for?
Mandakini (Mandy) Sharma works for Exelixis
What is Mandakini (Mandy) Sharma's role at the current company?
Mandakini (Mandy) Sharma's current role is Senior CMC Consultant.
What is Mandakini (Mandy) Sharma's email address?
Mandakini (Mandy) Sharma's email address is ma****@****nza.com
What is Mandakini (Mandy) Sharma's direct phone number?
Mandakini (Mandy) Sharma's direct phone number is +140859*****
What schools did Mandakini (Mandy) Sharma attend?
Mandakini (Mandy) Sharma attended Rutgers University, Pennsylvania State University College Of Medicine, Indian Institute Of Technology, Bombay, Aps Delhi.
What skills is Mandakini (Mandy) Sharma known for?
Mandakini (Mandy) Sharma has skills like Biotechnology, Monoclonal Antibodies, Biopharmaceuticals, Protein Purification, Life Sciences, Protein Chemistry, Technology Transfer, Laboratory, Hplc, Process Simulation, Drug Discovery, Immunology.
Who are Mandakini (Mandy) Sharma's colleagues?
Mandakini (Mandy) Sharma's colleagues are Aaliyah Mumin, Sphr, Monte Montgomery, Tiffany Nguyen, Ishai Padawer, Joel Wallace, Eric Meuser, Chris Summers.
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