Amneris Febles Negrón
San Juan,Puerto Rico
Summary
Principal Scientist with more than 12 years working within Pharmaceutical industry. Determined and focused professional, educated in safety procedures, processes and regulations. Experienced managing equipment and cleaning process development projects from early design through execution phases.
Overview
12
12
years of professional experience
Work History
Principal Scientist-TS/MS Cleaning
Eli Lilly And Company
08.2022 - Current
- Lead technical support to cleaning processes in areas of pharmaceutical product manufacturing and packaging.
- Responsible for cleaning process control strategy with knowledge of cleaning including its scientific background so that it can monitor and evaluate its performance to react preventively (process improvements) and/or correctively in situations that require actions. to be taken.
- Responsible for documentation and maintenance of cleaning validation program.
- Actively identify and lead activities aimed at improving cleaning processes focused on productivity, quality improvements and others aligned with business initiatives as identified.
- Lead technical evaluation of cleanings on impact and/or requirements related to process steps, materials, facilities, equipment, systems and/or utilities that are introduced, modified or eliminated from manufacturing processes.
- Work in integrated manner with different areas to which technical service of cleaning processes is provided, ensuring accessibility and support aligned with activities of area.
- Ensure that technical activities to be carried out will always be in alignment with procedures, regulations and regulatory commitments applicable to manufacturing processes.
- Conduct comprehensive risk assessments before undertaking experiments to ensure safety compliance with organizational guidelines.
- Collaborate effectively with colleagues across various departments, fostering culture of open communication and teamwork.
- Confer with scientists, engineers or others to plan or review projects or to provide technical assistance.
- Provide mentoring on technical aspects of cleaning to other process scientists.
- Prepared reports and oral presentations.
Sr. Process Scientist (Sterilization & Equipment)
Bristol Myers Squibb
05.2018 - 07.2022
- Contractor (Ultimate Solutions Corp.).
- Responsible for providing technical support.
- Accountable for design, performance and documentation of validation studies for process improvement as assigned by Manufacturing Technology leadership.
- Performed complex troubleshooting and assisted leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Designed characterization/development protocols, resulting in valid conclusions being drawn from collected data.
- Implemented quality control measures to ensure accuracy and reliability of experimental results.
- Simultaneously managed several complex projects, meeting all pertinent milestones.
Computer System Validation Specialist
Amgen
01.2018 - 03.2018
- Contractor (Ultimate Solutions Corp.).
- Contributed to Adaptive Assembly Line Project documentation.
Validation Specialist
Glaxosmithkline Llc
09.2017 - 01.2018
- Contractor (Ultimate Solutions Corp.).
- Contributed to Remediation Start-Up after atmospheric event (Hurricane María).
Technical Scientist (Cleaning Validation)
Johnson & Johnson's McNeil Healthcare, LLC
07.2014 - 05.2015
- Contractor (Ultimate Solutions Corp.).
- Worked in the Cleaning Validation program of OTC drug products as part of the McNeil Consent Decree Work Plan Step LP-06-VL-06D.
- Contributed in cleaning development and subsequent validation of Granulation, Compression, and Coating/Printing equipment.
- Key player in cleaning development and subsequent validation of Packaging equipment.
- In charge to coordinate and execute cleaning validation activities.
Manufacturing Lead Investigator
Johnson & Johnson's McNeil Healthcare, LLC
07.2012 - 07.2014
- Contractor (Ultimate Solutions Corp.).
- Responsible to complete Level 1, Level 2 and, Level 3 investigation reports in a timely manner and in compliance, identifying root cause and determining corrective/preventive actions for site manufacturing and packaging operation departments.
- Reduced case backlog by prioritizing high-impact investigations and allocating resources accordingly.
- Maintained detailed records of investigation activities for easy reference during investigation reviews, audits or legal proceedings.
- Evaluated existing workflows and implemented process improvements that increased team efficiency and productivity.
- Conducted thorough investigations to achieve successful closures and client satisfaction.
- Participated in cross-functional teams tasked with addressing specific challenges.
- Increased client satisfaction through regular updates on investigation progress and prompt responses to inquiries.
- Collected, analyzed and interpreted information, documentation, and physical evidence associated with investigations.
- Carefully documented statements, observations, findings and evidentiary materials.
- Conducted interviews with personnel and documented investigative findings.
- Prepared detailed reports.
Education
Bachelor of Science - Science
Universidad De Puerto Rico
Río Piedras, Puerto Rico05.2011
Skills
- Technical Writing Expertise
- Process Development
- Data/Results Analysis
- Attention to Detail
- Team Collaboration
- Active Listening
- Customer-focused approach
- Results-driven focus
Languages
Spanish
Native or Bilingual
English
Full Professional
Timeline
Principal Scientist-TS/MS Cleaning
Eli Lilly And Company
08.2022 - Current
Sr. Process Scientist (Sterilization & Equipment)
Bristol Myers Squibb
05.2018 - 07.2022
Computer System Validation Specialist
Amgen
01.2018 - 03.2018
Validation Specialist
Glaxosmithkline Llc
09.2017 - 01.2018
Technical Scientist (Cleaning Validation)
Johnson & Johnson's McNeil Healthcare, LLC
07.2014 - 05.2015
Manufacturing Lead Investigator
Johnson & Johnson's McNeil Healthcare, LLC
07.2012 - 07.2014
Bachelor of Science - Science
Universidad De Puerto Rico
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