Experience

ERT

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Project Manager

  • Jun 2021 - Present

  Project manager within the Cardiac Safety team Project manager within the Cardiac Safety team



Covance

• United States
• Research Services
• 700 & Above Employee

• Proposal Manager

  • Jun 2019 - Present



Envigo ++++

• United States
• Research
• 300 - 400 Employee

• Proposal Manager

  • Mar 2018 - Jun 2019

  Applying knowledge and skills developed during the time working within the operational departments at Envigo to work with customers to achieve their objectives in pharmaceutical development.Consistently putting together high quality, scientifically accurate proposals to the meet customers deadlines. Developing commercial skills relevant to a contract research environment. Identifying opportunities for process improvements and working with senior management to implement. Collaborating with scientific experts and other commercial departments to improve quality of proposals supplied to customers. Building and maintaining effective relationships with internal experts as well as customer contacts.Mentoring and developing junior members of start, presenting on topics of expertise and further developing personal knowledge in pharmaceutical development.

• Study Manager

  • Aug 2016 - Mar 2018

  Worked as a Study Director on method validation studies, ensuring studies are conducted to the relevant regulatory and scientific standards. Acting as a Principle Investigator ensuring sample analysis work is completed in a timely and compliant fashion. Responsible for developing/transferring analytical methods suitable for method validation. Experienced as a Bioanalytical Project Manager as part of a clinical trial, ensuring compliance of work to GCP standard and delivery of data on a ‘fast-turnaround’ basis. Maintaining effective communication and building good working relationships with colleagues as well as internal and external customers. Troubleshooting analytical issues on assigned studies and communicating any issues to stakeholders. Working as a subject matter expert on a major company project for process improvements. Supporting the training and development of junior staff, running training sessions as well as ‘on the job’ training. Continuing development as 5S expert, supporting process improvements to improve efficiency and quality of work. Continuing as a Watson LIMS super user – designing and delivering training for new and advanced users.

• Study Co-ordinator

  • Nov 2015 - Aug 2016

  Study Co-ordinator within the Department of Bioanalysis at Envigo. Responsible for conducting sample analysis and bioanalytical method validation using LC-MS/MS techniques within a GLP environment. Providing training for new staff in sample analysis techniques and regulatory compliance. 'Super user' for Watson LIMS system for department, resolving user issues, liaising with the system manager and providing training. Troubleshooting of analytical issues. 5S expert for the department, driving process improvement and eliminating waste within the department.

• Study Analyst

  • Sep 2013 - Nov 2015

  Study analyst within the Deptartment of Bioanalysis at Envigo. Responsible for conducting sample analysis and bioanalytical method validation using LC-MS/MS techniques within a GLP environment. Contributing to method development, data checking and reporting to meet deadlines. Assisting in 'on the job' training for new starters. Working with study management to ensure that client expectations are maintained. Liaising with and maintaining working relationships with other departments. Received recognition awards for maintaining high quality work. Lab monitor role – taking ownership over a lab area to ensure compliance and following up on any issues. Fire Warden responsibilities – ensuring evacuation in fire situations and fire risk assessment.Gave a presentation at the 21st Reid Forum: When is a robust method not robust, exploring when a validated assay didn't meet acceptance criteria, and efforts taken to resolve and improve internal processes.



Greggs

• Food & Beverages
• 700 & Above Employee

• General Assistant

  • Aug 2007 - Sep 2009

  Providing good clear customer service – following health and safety regulations including end of day hygiene regulations. Providing good clear customer service – following health and safety regulations including end of day hygiene regulations.