Mandakini (Mandy) Sharma

Mandakini (Mandy) Sharma Email and Phone Number

Senior CMC Consultant @ Exelixis
California, United States
Mandakini (Mandy) Sharma's Location
San Francisco Bay Area, United States, United States
Mandakini (Mandy) Sharma's Contact Details

Mandakini (Mandy) Sharma work email

Mandakini (Mandy) Sharma personal email

About Mandakini (Mandy) Sharma

• 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

Mandakini (Mandy) Sharma's Current Company Details
Exelixis

Exelixis

View
Senior CMC Consultant
California, United States
Website:
exelixis.com
Employees:
51
Mandakini (Mandy) Sharma Work Experience Details
  • Senior Cmc Consultant
    California, United States
  • Exelixis
    Head Of Biologics Cmc Program Management
    Exelixis Jul 2023 - Present
    Alameda, California, Us
  • Lonza
    Head Of Project Management
    Lonza Jan 2021 - Jul 2023
    Basel, Ch
  • Boehringer Ingelheim
    Head Of Project Management, Quality Control
    Boehringer Ingelheim Feb 2019 - Jan 2021
    Ingelheim Am Rhein, Rhineland-Palatinate, De
  • Boehringer Ingelheim
    Cmc Project Leader, Associate Director
    Boehringer Ingelheim Oct 2016 - Jan 2019
    Ingelheim Am Rhein, Rhineland-Palatinate, De
  • Boehringer Ingelheim
    Associate Director- Process Science
    Boehringer Ingelheim Dec 2014 - Sep 2016
    Ingelheim Am Rhein, Rhineland-Palatinate, De
    Managed 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.
  • Biocon
    Senior Scientific Manager
    Biocon Jul 2012 - Aug 2014
    Bangalore, Karnataka, In
    CMC lead for partner project, Manage the Late Stage Pocess Development downstream lab, Lead for Process Characterization and Validation for multiple projects.
  • Genentech
    Sra, Purification Scientist, Process Development
    Genentech Jun 2004 - May 2012
    South San Francisco, California, Us
  • Stanford University
    Research Associate
    Stanford University Dec 2003 - Jun 2004
    Stanford, Ca, Us
    Stem Cell Research
  • Rutgers Robert Wood Johnson Medical School
    Graduate Student Researcher
    Rutgers Robert Wood Johnson Medical School May 2001 - Sep 2003
    New Brunswick, Nj , Us
  • Penn State University
    Research Fellow
    Penn State University Aug 2000 - May 2001
    University Park, Pa, Us
    As PhD Candidate worked on Gene Silencing

Mandakini (Mandy) Sharma Skills

Biotechnology Monoclonal Antibodies Biopharmaceuticals Protein Purification Life Sciences Protein Chemistry Technology Transfer Laboratory Hplc Process Simulation Drug Discovery Immunology Lifesciences Cmc Development Cmc Regulatory Affairs Production Process Development

Mandakini (Mandy) Sharma Education Details

  • Rutgers University
    Rutgers University
    Genetics
  • Pennsylvania State University College Of Medicine
    Pennsylvania State University College Of Medicine
    Genetics
  • Indian Institute Of Technology, Bombay
    Indian Institute Of Technology, Bombay
    Biotechnology
  • Aps Delhi
    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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