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Jessica Claire
  • , , 100 Montgomery St. 10th Floor
  • Home: (555) 432-1000
  • Cell:
  • resumesample@example.com
Professional Summary

Ambitious team Leader with 15 years of experience in the Finished Product environment. Engaging and motivational supervisor skilled at training, coaching and developing high-performing scientists within the Analytical QC-External and Internal groups. Leader amongst cross-departmental project teams to ensure all project timelines and milestones were met within a cGMP Pharmaceutical API and . Planned and coordinated resource allocation, projects and administrative responsibilities. Oversaw the review and delivery of data and documents to customers and FDA. Evaluated technical issues and served as a resource inside and outside of the department for resolutions. Communicated frequently with internal personnel and outside customers to ensure expectations were met. Prepared and submitted reports for the QC Finished Products department.

Skills
  • Ability to lead successfully within EXTENDED project teams and handle multiple challenges under pressure.
  • Excellent verbal and written communication skills.
  • Ability to effectively work across MULTI-levels, functions and companies
  • Solid track records in method development, method transfer and validation for commercial manufacturing.
  • Technical author and reviewer (OOT,OOS,DEV,CAPA).
  • In-depth theoretical and hands-on experience in various analytical techniques and instrumentations.
  • Effective scheduler
  • Team expert for investigations, and troubleshooting technical issues with methods and equipment.
  • Product Knowledge
  • Daily Workflow Improvement
  • Self-motivated professional
Work History
Team Leader of Technical Transfer & Validation, 12/2019 to Current
Advanced Testing LaboratorySanford, ME,
  • Mayne Pharma (Formerly Metrics Inc.).
  • Mentored and guided employees to foster proper completion of assigned duties.
  • Built strong relationships with customers through positive attitude and attentive response.
  • Assisted [Job title] with new hire processing and existing training programs.
  • Molded team and embraced change to adapt within dynamic market.
  • Optimized customer support by establishing collaborative work environment.
  • Facilitated training for associates through daily coaching and regular performance appraisals.
  • Maintained regulatory compliance for all projects.
  • Researched patents, literature and scientific information in databases.
  • Evaluated lab findings to make interpretations and write OOT/OOS, CAPA reports.
  • Collaborated with cross-site and cross-functional teams in research and development, EH&S, product marketing and manufacturing engineering to establish framework for successful development programs and align objectives across all teams.
  • Modified and adapted standard methods and procedures to solve analytical problems.
  • Developed and implemented performance improvement strategies and plans to promote continuous improvement.
  • Emphasized personal safety and emotional well being of staff and program participants to encourage healthy activities.
  • Recognized areas of concern, assisted in intervention or referrals and participated in conferences to formulate solutions.
  • Minimized resource and time losses by addressing employee or production issue directly and implementing timely solutions.
Principal Scientist/Technical Lead, 06/2016 to 12/2019
Mayne PharmaCity, STATE,
  • Drove development of analytical testing, including in-process, raw material and release testing.
  • Supported development of analytical testing, including in-process, raw material and release testing.
  • Prepared reports, publications and oral presentations.
  • Designed and implemented assay transfer protocols to contract labs, operational quality control standards and stability programs.
  • Planned and scheduled deadlines for projects per month.
  • Developed and executed assay transfer protocols to contract labs.
  • Led [Type] investigations, resulting in [Result].
  • Organized and created early stability programs for [Type] drugs in clinical stages of development.
  • Supported validation and qualification testing of [Type] facility.
  • Developed testing method validation plans for drug candidates in phase III clinical trials.
  • Provided analytical support and consultation services through [Task] and [Task].
  • Conducted performance reviews and participated in hiring process of new employees.
QC Finished Products, Supervisor, 08/2013 to 06/2016
Metrics IncCity, STATE,
  • Mentored newly hired employees on operating equipment and safety and developed training manual to use for reference purposes.
  • Interviewed, hired and trained new employees for lab positions.
  • Evaluated employee performance and coached and trained to improve weak areas.
  • Maintained compliance with company policies, objectives and communication goals.
  • Maintained clean and well-organized quality control lab areas to avoid violations or unnecessary work delays due to hazards or inefficient layouts.
  • Use proper controls for analytical instrumentation, validate and verify data and take corrective action, when necessary
  • Maintain instrumentation and perform procedures for product testing purposes when needed.
  • Work on cross-functional teams as analytical subject matter expert
Senior Chemist , 08/2010 to 08/2013
Metrics IncCity, STATE,
  • Compare laboratory data against specifications and trend data where applicable to determine if results meet requirements.
  • With guidance, propose applicable specifications based on data obtained in support of certain programs
  • Ensure proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
  • Ensure accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
  • Direct and assist in laboratory personnel training when required
  • Under general supervision, author standard operating procedures, analytical testing procedures, final submission ready documents, and create document templates for use by junior staff members
  • Independently perform routine and complex testing for chromatographic and spectrophotometric methods (HPLC, GC, UV) of analysis for new chemical entities and/or drug products
  • Under general supervision, evaluate methods of analysis for chemical entities and drug product formulations and provide solutions and recommendations for ensuring robust methods are developed and/or validated
  • Interpret data and make recommendations to management for improvement or potential concerns
  • Create report templates and/or enter data into established reports/templates or software based systems
  • May serve as a technical liaison between functional groups such as Quality Assurance and metrology
  • Review routine and complex laboratory experiments for accuracy and provide guidance to junior staff to ensure future compliance
Education
Bachelor of Science: Chemistry, Expected in 06/2001
East Carolina University - Greenville, NC
GPA:
Bachelor of Arts: Biology, Expected in 06/2001
East Carolina University - Greenville, NC
GPA:

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Resume Overview

School Attended

  • East Carolina University
  • East Carolina University

Job Titles Held:

  • Team Leader of Technical Transfer & Validation
  • Principal Scientist/Technical Lead
  • QC Finished Products, Supervisor
  • Senior Chemist

Degrees

  • Bachelor of Science
  • Bachelor of Arts

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