Summary
Overview
Work History
Education
Skills
Accomplishments
Timeline
Generic

Luis Mejia

Summary

Accomplished Process Engineer/Scientist with more than 10 years enforcing compliance and improving steps in accomplishing goals. Successful and driven individual committed to proactive planning and goal-oriented work.

Overview

22
22
years of professional experience

Work History

Process Scientist (Contract)

AstraZeneca
09.2020 - 03.2023
  • Led tech transfer and PV efforts of commercial COVID-19 mAbs processes (upstream and downstream) into external manufacturing sites (CDMO) located overseas
  • Tech Transfer Pilot Plant scale 2000L bioreactor to 3 X 4000L and 15000L Bioreactors (Fed-Batch)
  • Part of team that supported regulatory submissions of Evusheld which was approved by the FDA for EUA, and ROW regulatory agencies
  • Reviewed and approval of PV reports to approve in a streamline timeline supporting EMA filing and ROW submissions
  • Reviewed and approved tech transfer and Process Validation documentation such as risk assessments, gap analyses, PPQ Protocols, Process control strategy, Process Validation Master Plan and batch records
  • Provided technical expertise to support preparation of regulatory submissions, and respond to questions from regulatory bodies
  • Responsible for completing PPQ by closing out NPI global change controls
  • Served as Manufacturing Technical Representative in CMC team
  • Technical liaison for commercial manufacturing
  • Conducted process monitoring per CPV strategy
  • Resolved issues, deviations, and negative trends by interfacing with relevant manufacturing site(s), Quality/Regulatory, Engineering, Validation, and Development to implement solutions

MSAT Scientist

Lonza Viral Therapies
05.2017 - 07.2020
  • Experience with Gene therapy/ viral vector processes
  • Using AAV and Adenovirus
  • Coordinated campaign preparation in close collaboration with Project Management in a CDMO environment
  • Was the Technical lead for both upstream and downstream
  • Role was client facing
  • Performed Tech Transfers from Client to Lonza manufacturing area where Fit to Plant assessments, such as Gap Analysis and process scalability assessments were conducted
  • Gained experience with WAVE-20, 50L(Perfusion) and 250L SUBs
  • Analyze data from PD and production runs
  • Design aseptic process for manufacturing scale
  • Evaluate fill finish process for low volume Bulk Drug Substance
  • Write/review Unicorn methods for AVB, AEX chromatography
  • Support APS of sterile processes
  • Identified critical raw materials and consumables
  • Design new disposable consumables adequate for aseptic processing
  • Established E&L risk assessment strategy for the entire site
  • Evaluate new technology, new equipment, write URS as required
  • Investigate and resolve complex and technical deviations
  • Propose CAPAs and process improvements
  • Directed project activities within a cross-functional team

Technical Services/ Manufacturing Science Principal Associate

Eli Lilly & Company
05.2013 - 05.2017
  • Supported eCTD submission
  • Monitor manufacturing performance of Upstream and Downstream processes
  • Was SME for the upstream manufacturing process
  • Was PIP supporting OOF to 11K Bioreactor cell culture scale up
  • Investigate high profile Non-Conformances/ Deviations
  • Ensure process is being executed per Control Strategy
  • Was SME supporting regulatory agency RTQs
  • Identify areas of process improvements and initiate change controls to implement these improvements
  • Was a member of the supply change notification team which identified potential process impacts based on supplier change notifications
  • Serve as a Subject Matter Expert (SME) on qualified processes to support regulatory filings of late phase processes
  • Owner of E&L Assessment Program where consumables used in various processes are scored for E&L risk

Process Development Associate (Scientist)

Eli Lilly & Company
04.2010 - 05.2013
  • Validated the small-scale model for downstream purification processes in the PD Process Validation group
  • Performed small-scale model qualification studies of Affinity chromatography and AEX chromatography using AKTA Avant systems
  • Write Unicorn methods as appropriate
  • Performed small-scale TFF to generate load material or Mab product
  • Lead or assist in the design, planning and execution of various model qualification studies, and range studies that identify OPPs, and CPPs
  • Performed FMEA assessments that identifies pCPPs to be studied
  • Designed studies using a multivariate statistical DoE approach, responsible for analyzing results

Biopharmaceutical Manufacturing Supervisor

Eli Lilly & Company
04.2008 - 03.2010
  • Responsible for executing and overseeing various protein purification processes
  • Ensure corporate and production goals are being met
  • Supervise a team of 4 reports that include 3 manufacturing operators and one Senior operator
  • Measures and appraises operator performances against job duties and company objectives
  • Write- up of NCEs and CAPAs
  • Driven area clearance and changeover activities when switching between various clinical products


Sr. Operator

Imclone Systems Inc
10.2006 - 04.2008
  • Responsible for executing and monitoring various protein purification processes
  • Act as Team lead on the production floor
  • Involved in coordinating process related activities in order to meet production timing goals
  • Write and revise batch records, SOPs, and forms
  • Maintain training on current cGMP
  • Worked on various systems such as Protein A chromatography, TFF, and viral filtration
  • Adhere to cGMPs and corporate compliance during day to day activities
  • Supported the activities of other departments as required.

Downstream Supervisor

Apptec Laboratory Services
04.2006 - 09.2006
  • Clinical manufacturing of harvested clarified bulk proteins
  • Supervised the execution of various types of large-scale chromatography, viral reduction methods, and TFF
  • Involved in NCE resolution, and writing CAPAs
  • Involved in coordinating personnel, materials and resources needed for processing
  • Revised SOPs and batch records to reflect process specs found in tech transfer forms
  • Responsible for interviewing candidates, and giving performance evaluations to current manufacturing associates.

Manufacturing associate II

Johnson & Johnson
05.2002 - 11.2004
  • Responsible for the purification of monoclonal antibodies according to SOPs in a class 10, 000 suite
  • Operated Harvest Clarification, Chromatography and U.F Skids
  • Responsible for CIPs and SIPs of equipment
  • Reviewed batch records for documentation errors
  • Batch record re-engineering and SOP revision

Virology Technician

Charles River Laboratories
11.2001 - 01.2002
  • Performing tissue culture safety assays with CHO, Vero, MDBK, Hep-2 cells
  • Testing client samples for the presence of various types of viruses, such as SV40, HSV-1, HSV-2, and Rubeola


Purification Technician

Immune Response Corporation King of Prussia, PA
07.2001 - 10.2001
  • Involved in various processes of the ultrafiltration and diafiltration of HIV-1 to be use as vaccine-based therapy
  • Worked in BSL-3 environment, according to cGMPs, GLP and OSHA regulations.

Education

M.S - Biology

West Chester University
West Chester, PA

B.Sc. - Biology, Chemistry

University Of Windsor
Windsor, ON

Skills

  • SQL, Design Expert, UNICORN, TrackWise and Spotfire JMP and MiniTab
  • Laboratory Experience
  • Clean Room experience
  • GMP industry experience
  • CMC experience
  • SEC-HPLC
  • SDS-PAGE, Western Blot
  • FITC immunofluorescence
  • Tissue culture of insect and mammalian cell lines (SH-SY5Y, Vero, CHO, BG2-c6, Hela, HEK293 and S2 cells etc)
  • Light microscopy systems
  • Fluorescence microscopy
  • Complex Problem-Solving
  • Molecular Biology
  • Lab Experiments and Research
  • USP
  • DSP
  • Chromatography
  • Tangential Flow Filtration
  • Normal Flow Filtration
  • Virus Inactivation/ Virus Filtration
  • Bioreactors
  • Microsoft Project
  • Tech Transfer
  • Process Validation
  • FMEA and Gap Assessment
  • Change Controls
  • New Product Introduction
  • Nonconformance/ Deviation investigations

Accomplishments

    In my role at Astrazeneca, Obtained Emergency Use Authorization for Evusheld antibody cocktail.

    Collaborated to get FDA approvals of Cyramza, Lartruvo, and Portrazza while working for Eli Lilly and Company.

Timeline

Process Scientist (Contract)

AstraZeneca
09.2020 - 03.2023

MSAT Scientist

Lonza Viral Therapies
05.2017 - 07.2020

Technical Services/ Manufacturing Science Principal Associate

Eli Lilly & Company
05.2013 - 05.2017

Process Development Associate (Scientist)

Eli Lilly & Company
04.2010 - 05.2013

Biopharmaceutical Manufacturing Supervisor

Eli Lilly & Company
04.2008 - 03.2010

Sr. Operator

Imclone Systems Inc
10.2006 - 04.2008

Downstream Supervisor

Apptec Laboratory Services
04.2006 - 09.2006

Manufacturing associate II

Johnson & Johnson
05.2002 - 11.2004

Virology Technician

Charles River Laboratories
11.2001 - 01.2002

Purification Technician

Immune Response Corporation King of Prussia, PA
07.2001 - 10.2001

M.S - Biology

West Chester University

B.Sc. - Biology, Chemistry

University Of Windsor

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Luis Mejia