Gaelle S.

Gaelle S. Email and Phone Number

Sr Manager Technical Operations @ Evofem Biosciences
Los Angeles, CA, US
Gaelle S.'s Location
Los Angeles Metropolitan Area, United States, United States
Gaelle S.'s Contact Details
About Gaelle S.

Professionnel bilingue de la validation et du contrôle de qualité avec une expérience dans la rédaction de protocoles de validation pharmaceutique ainsi que dans la formation du personnel de production afin d'assurer la conformité avec les directives règlementaires. Familière avec les PON, BPF et BPL ainsi que des techniques de laboratoire avancées telles que IR et CLHP.

Gaelle S.'s Current Company Details
Evofem Biosciences

Evofem Biosciences

View
Sr Manager Technical Operations
Los Angeles, CA, US
Website:
evofem.com
Employees:
43
Gaelle S. Work Experience Details
  • Evofem Biosciences
    Sr Manager Technical Operations
    Evofem Biosciences
    Los Angeles, Ca, Us
  • Evofem Biosciences
    Sr. Director Manufacturing, Supply Chain & Logistics
    Evofem Biosciences Sep 2024 - Present
    San Diego, Ca, Us
  • Evofem Biosciences
    Director Manufacturing , Supply Chain & Logistics
    Evofem Biosciences Oct 2022 - Sep 2024
    San Diego, Ca, Us
  • Evofem Biosciences
    Director Of Manufcturing
    Evofem Biosciences Aug 2021 - Oct 2022
    San Diego, Ca, Us
  • Evofem Biosciences
    Sr Manager Technical Operations
    Evofem Biosciences Mar 2020 - Aug 2021
    San Diego, Ca, Us
    Managing pharmaceutical operations ranging from manufacturing, clinical and commercial supply, and other commercialization activities. Act as a liaison for the manufacture of Evofem’s drug product at external contract development and manufacturing organizations (CDMOs). Coordinate, and execute external drug product development and manufacturing activities.
  • Ispe San Diego Chapter
    President-Ispe San Diego Chapter
    Ispe San Diego Chapter Dec 2022 - Oct 2023
    San Diego, Us
    ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members by leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle.
  • Ispe San Diego Chapter
    Women In Pharma Board Of Directors-Ispe San Diego Chapter
    Ispe San Diego Chapter Mar 2020 - Dec 2022
    San Diego, Us
  • Azzur Group
    Director Of Client Relations
    Azzur Group Oct 2017 - Mar 2020
    Hatboro, Pennsylvania, Us
  • Azzur Group
    Project Manager
    Azzur Group Jan 2016 - Mar 2020
    Managed a team of seven employees in the field of engineering, cleaning, process and equipment validation.Build a high performance team by recruiting, screening and mentoring,Ensured continuous improvement and consistency with the regulatory and business requirements by providing oversight over the validation process. Responsible for the Business Development in the Los Angeles area.
  • Azzur Group
    Senior Validation Specialist
    Azzur Group 2015 - Jan 2016
    Developed equipment and process validation protocols and reports
  • Ispe Greater Los Angeles Area Chapter
    Young Professional Co- Chair Board Of Directors Ispe La Chapter
    Ispe Greater Los Angeles Area Chapter Oct 2019 - Feb 2020
    Irvine, California, Us
    Promoting opportunities for mentorship, leadership, networking, and career advancement of Young Professionals in the LA Pharmaceutical and Life Science Industry.
  • Sandoz
    Senior Validation Specialist
    Sandoz 2013 - 2015
    Basel, Basel-Stadt, Ch
    Developed equipment and process validation protocols and reportsReduced project costs by overseeing consultants work during integration process
  • Johnson & Johnson
    Validation Supervisor & Change Control
    Johnson & Johnson 2012 - 2013
    New Brunswick, Nj, Us
    Ensured continuous improvement and consistency with respect to company regulations and requirements by providing oversight over the validation processIncreased awareness of the importance of a consistent approach to quality by planning and organizing training activities related to the different phases of validation
  • Johnson & Johnson
    Quality Assurance Validation Associate
    Johnson & Johnson 2012 - 2012
    New Brunswick, Nj, Us
    Prevented the enterprise from of having negative observations during regulatory audits by developing equipment and process validation protocols Improved validation procedure to make the process lean and instil a culture where validation was part of the production process
  • Confab Laboratories
    Validation Specialist (Cleaning)
    Confab Laboratories 2010 - 2012
    Saint-Hubert, Quebec, Ca
    Improved the cleaning procedures by developing and implementing protocols and reports for cleaning processesManaged cleaning products and equipment matrix in accordance with risk assessment of solid and liquid productsEnsured continuous training of staff to guarantee proper cleaning of equipment and accurate sampling techniques

Gaelle S. Skills

Validation Project Management Gmp Change Control Sop Cleaning Validation Process Validation Quality System Bpf Ansm Medical Device Fda Glp 21 Cfr Part 11 Trackwise Lean Manufacturing Pharma Industry Qa

Gaelle S. Education Details

  • Université De Montréal
    Université De Montréal
    Chemistry
  • Collège Maisonneuve
    Collège Maisonneuve
    Health Science
  • Université De Sherbrooke
    Université De Sherbrooke

Frequently Asked Questions about Gaelle S.

What company does Gaelle S. work for?

Gaelle S. works for Evofem Biosciences

What is Gaelle S.'s role at the current company?

Gaelle S.'s current role is Sr Manager Technical Operations.

What is Gaelle S.'s email address?

Gaelle S.'s email address is ga****@****oup.com

What schools did Gaelle S. attend?

Gaelle S. attended Université De Montréal, Collège Maisonneuve, Université De Sherbrooke.

What are some of Gaelle S.'s interests?

Gaelle S. has interest in Social Services, Civil Rights And Social Action, Science And Technology, Disaster And Humanitarian Relief, Human Rights, Animal Welfare, Health.

What skills is Gaelle S. known for?

Gaelle S. has skills like Validation, Project Management, Gmp, Change Control, Sop, Cleaning Validation, Process Validation, Quality System, Bpf, Ansm, Medical Device, Fda.

Who are Gaelle S.'s colleagues?

Gaelle S.'s colleagues are Ellen Thomas, Elizabeth Haag-Delahera, Lynette Newsom, Robin Geyer, Helen Tran, Lisa Goldschmidt, Erin Hayes.

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