Bernard Djom
Swampscott,USA
Summary
Experienced biomedical and pharmaceutical professional with expertise in contract manufacturing organizations. Specializes in technology transfer, late-phase drug development, and clinical trials management. Recognized for strategic leadership, operational excellence, team leadership, conflict resolution, and operational strategy. Currently pursuing a Doctorate in Business Administration focusing on organizational leadership and strategic operations. Innovative and goal-oriented management professional dedicated to continuous improvement. Skilled at mediation, conflict resolution, and driving company growth through strategic actions.
Overview
21
21
years of professional experience
Work History
Manufacturing Operations Site Manager
Vertex Pharmaceuticals
08.2022 - Current
- Manage department CAPEX for resources, equipment and materials in conjunction with procurement
- Ensure effective hiring and training of personal to meet expected metrics
- Ensure site meets and exceeds department annual established KPI's
- Lead multiple cell lines for clinical projects using pluripotent stem cells
- Create, revise, and review controlled documents including Standard Operating Procedures (SOPs) and Batch Records for manufacturing
- Leads, investigates, and collaborates with cross-functional stakeholders regarding quality systems, including quality events, deviations, CAPAs, change controls, and risk assessments
- Manage manufacturing scheduling and batches release in coordination with cross-functional groups
- Drives resource planning such as materials, personnel, and equipment to ensure seamless operation of manufacturing activities
- Manage, lead and coach supervisors and manufacturing senior specialists
- Lead site weekly GEMBA walk
Owner and founder
Djom Biosciences Consultant LLC
02.2022 - Current
- Leads a small organization that contracts with local CDMO's for MFG work and projects
Director of Manufacturing Operations
Performance Cell Manufacturing
10.2021 - 01.2022
- Manage and direct manufacturing operations to meet or to exceed expectations
- Develop and improve manufacturing processes in conjunction with other departments
- Hire staff, train, plan manufacturing operations per client and project
- Lead project proposal and quote in conjunction with business development department
- Create, review, and revise critical operations documents
- Plan, order materials and equipment for successful manufacturing operations
- Actively participate to multiple technical client's project meetings
- Coordinate activities between departments and lead site leadership weekly meeting
- Coach, train, and mentor department low level managers
- Actively part of the site leadership team
- Ensure site compliance OSHA and other regulations bodies
- Performed internal audits and areas of improvement
- Performed other duties as required
Manufacturing manager
National Center for Therapeutics Manufacturing - FUJIFILM Diosynth
06.2021 - 10.2021
- Direct and provide technical leadership for the overall manufacturing operations
- Ensure the full compliance to OSHA and cGMP's regulations of manufacturing operations
- Ensure compliance with current federal and local regulations
- Direct manufacturing staff to ensure the timely delivery and right the first-time execution of manufacturing operations
- Develop and manage the budget requirements for each fiscal year
- Monitor and report progress of projects within agreed timelines to meet clients and company objectives
- Represent the organizational unit as the prime internal and external contact for NCTM site manufacturing operations
- Maintain adequate levels of materials in support of manufacturing operations
- Responsible for participating in pre-approval inspections, FDA audits and client audits
- Write deviations and CAPA's
- Hire, train, develop and evaluate staff
- Take corrective action as necessary on a timely basis and in accordance with Company policy
- Direct and monitor department supervisors to accomplish goals of the manufacturing plan, consistent with established manufacturing and safety procedures
- Act as a liaison between department management/subordinate levels, executive leadership/department supervisor levels for better communication
Cell Therapy manufacturing Supervisor
Catalent CGT
08.2019 - 06.2021
- Successfully lead multiple client projects from technology transfer to GMP late phases for CDMO
- Oversee multiple manufacturing contract projects to ensure Catalent expectations and requirements are met
- Actively participated to multiple weekly cross-project and technical meetings with clients online and onsite
- Promote operational excellence within the organization by supporting department initiatives, continuously improving and innovating processes and identifying opportunities for improvement
- Continually meet with multiple vendors/suppliers for strategic choices of price and quality of supplies and equipment
- Responsible for establishing and editing manufacturing production calendar based on campaign, processes and project
- Manage department CAPEX for resources, equipment and materials in conjunction with procurement and project managers
- Lead a crossed function group assigned of acquiring and validating new equipment for manufacturing cleanrooms
- Liaise between quality control (QC), Quality Assurance (QA), and other stakeholders to ensure continues and effective delivery
- Work closely with QA department to insure effective implementation of QMS within manufacturing
- Create, finalize and/or approve documentation as policies procedures/instructions/forms/protocols approved by any relevant stakeholder and clients
- Set up an efficient system for equipment (re)qualification protocol writing under Shared Service responsibilities
- Ensure execution and implementation of any/all Deviation (Dev) and Curative and Preventive Actions (CAPA) in manufacturing
- Supervise and manage with highly efficiency a team of 8 manufacturing associates, experts and senior associates
- Accountable to ensure staff are trained and skills set meet expectation of company high performance
- Perform annually staff reviews per company global established KPI's
- Ensure training plan/matrix for Production staff is adequate, effective and updated
- Lead validation/qualification cleaning project of a plant of 8 cleanrooms ISO 7 class
- Set up and manage aseptic program in classified areas to meet/exceed company global requirement
- Developed and implemented strategies for manufacturing to meet or to exceed efficiency target
- Guaranteed production equipment management in partnership with Facility and Production
Manufacturing Team Lead Upstream
Lonza
11.2018 - 06.2019
- Responsible for upstream manufacturing of clinical and/or commercial grade cell therapeutic products in accordance to established SOPs
- Maintained and stocked clean room environment and monitor expiration of material
- Lead and coordinated all activities related to upstream operations
- Demonstrated mastery knowledge of Upstream Processes, planning and scheduling operational activities, and evaluation of Product Impact Assessment
- Acted as a Subject Matter Expert for upstream operations, trainer in all upstream related topics as well as manufacturing go to person regarding this area
- Actively coached and mentor other technicians on upstream procedures and provides feedback to management regarding day-to-day performance
- Participated in upstream operations, aseptic manufacturing of clinical and/or commercial grade products in accordance to established SOPs
- Participated in client face to face discussions related with project and operations
- Demonstrated mastery knowledge of Upstream Processes and Knowledge of Aseptic Manufacturing/Processing
- Performed investigations pertaining to deviations and internal audits
- Served as the back-up for area Supervisor
- Acted as a primary trainer for Upstream Operations
- Performed other duties as assigned
Manufacturing Associate III
Amgen
08.2014 - 11.2018
- Lead and performed aseptic techniques for Cell Culture process and passages per standard operating procedures and batch record for cancer vaccine
- Wrote non-conformance and CAPA using TrackWise
- Wrote, created and revise SOP's and CAPA implementation in manufacture
- Co-lead multiple government bodies inspections (FDA, EMA, Health Canada...)
- Coached, qualified trainer and evaluator in aseptic technics and behavior for manufacturing staff
- Qualified trainer in Biosafety cabinet operations
- Organized and lead process improvement and optimization studies for upstream
- Wrote and lead protocol for engineering studies
- Organized and lead Engineering Testing Plan for validation for upstream operations
- Worked cross department to support validation and engineering runs
- Performed and trained aseptic technics for drug's fill substance in RABS (Restricted Area Barrier System)
- Lead process improvement for refill drug substance
- Lead 5S operation in Manufacturing
- Lead annual aseptic qualification and re-qualification for downstream and upstream staff in manufacturing
- Checked and analyzed Key Operating Parameters for upstream operations
- Performed cells infection and harvest
- Performed clarification (first step of Ultra Filtration)
- Operated several instruments in cell culture area including microscope, Nova Bioprofile, heater block, Mobius system, cell rack, pH meter…
- Operated Getinge and Belimed autoclaves
- Managed sample in LIMS system from sample manager
- Prepared buffers and other solutions use in manufacturing
Manufacturing Associate III, Shift Lead
Baxter Biosciences
05.2014 - 07.2014
- Performed expansion of mammalian cells culture in roller bottles, flasks and cellmate
- Scheduled personnel to ensure coverage of all required processes
- Performed Production Batch Record review prior to submission to supervisor
- Wrote, created reviewed SOP's and other lab document
- Operated Biosafety Cabinet, microscopes, incubators, mixing equipment, autoclaves, and other manufacturing equipment
- Completed required documentation, GMP recording of entries and comments in batch records, forms and protocols
- Cleaned equipment and parts for use in cGMP
- Prepared equipment and assemblies to be autoclaved
Process Development Manufacturing Engineer Associate
Sanofi Pasteur
01.2013 - 09.2013
- In charged of media/buffer preparation
- Participated in process improvement studies
- Operated various lab equipment including nova, nucleo counter, vi-cell'XR, autoclave, filter integrity tester, microscope
- Performed cell culture expansion and aseptic techniques
- CIP/SIP(Clean-In-Place/Steam-In-Place) on centrifuge and sampling on bioreactors
- Created, edited and revised SOP's, and general laboratory documents (GMP and non-GMP)
- In charged of laboratory logistics including ordering and managing laboratory supplies
- Investigated contaminations and assisted in CAPA (Corrective Action Preventive Action) writing
Biomedical Laboratory Supervisor
Upham's Corner Health Center
01.2010 - 01.2013
- Managed technical personnel and phlebotomist technicians
- Prepared SOP's, general laboratory documents and study reports
- Managed laboratory budget and capital expenses
- Trained new and less experienced staff and extern's phlebotomists
- Collection and processing of tissues and body fluid including urines for submission to clinical laboratories
Manufacturing Technician, Cell Culture
Shire HGT
02.2008 - 01.2010
- Operated production equipment according to SOP's and cGMP documents
- Experienced in cell culture, aseptic techniques using roller bottles and flasks
- Performed Clean-In-Place procedures (CIP), Steam-In-Place (SIP) and Pressure Hold
- Operated pH meters, conductivity meters, osmometer, cedex, nova, and Cell Mate Robots…
- Created and revised SOP's and other laboratory documents
- Knowledgeable of local and international regulations (FDA, EU, Health Canada)
- Commissioned and validated cell culture laboratory equipment including Cell Mate Robot, Nova, and Cedex
- In charged of updating Material Data Safety Sheets binders
HIV/AIDS Service Manager
Upham's Corner Health Center
01.2007 - 02.2008
- Lead in clinical research studies to evaluate HIV therapeutics (vaccine)
- Wrote and reviewed patients consent forms for clinical trials at Fenway Health Community Center and Brigham and Women's Hospital
- Supervised a team of nurses and social case managers
- Served as a liaison between Upham's Corner Health Center and Boston Public Health Commission
- Reviewed clients' medical records for up-to-date care plans, changes in address, laboratory results and other contractual requirements
- Provided comprehensive HIV/AIDS and STD training for interns and other department staff
- Planned and coordinated National HIV/AIDS Testing Week and Awareness Day (2005- 2008)
- Co-hosted weekly public health TV program for the prevention of HIV/AIDS and STD's
Community Health Educator (HIV/AIDS and STD)
Boston Medical Center
09.2004 - 01.2007
- Counseled diverse population for pre- and post-HIV/AIDS and STD's testing
- Conducted individual & group seminars on STD/HIV/AIDS prevention
- Targeted community organizations and high-risk groups with outreach
- Performed specimen blood collection and transport
- Counseled diverse clientele for pre- and post-HIV/AIDS and STD testing
- Conducted highly informative individual and group seminars on STD/HIV/AIDS prevention
Education
Doctor of Organizational Leadership And Operations Strategy -
Northcentral University
09.2026
Executive MBA -
Quantic School of Technology and Management
04.2022
B.S - Biomedical Laboratory and Clinical Sciences
Boston University
01.2017
No Degree -
University of Delaware
05.2017
Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics -
Harvard Extension (Harvard Law School Online)
03.2018
Medical Science Liaison Training Certificate -
04.2019
Skills
- Stem cells/cell expansion
- cGMP/GDP manufacturing
- Quality Systems
- Community Advisory Board member
- Team leadership
- Problem-solving
- Conflict resolution
- Site safety
- Site management
- Multitasking and organization
- Safety procedures
- Agility
- Cost estimation
- Strategic planning
- Shift scheduling
- Operations management
- Analytical thinking
- Inventory management
- Procedures development
- Safety monitoring
- Data analysis
- Coaching and mentoring
- Emergency response
- Process improvement
- SOP development
- Staff evaluation
- Trends analysis
- OSHA compliance
- Financial management
- Verbal and written communication
- Planning and design
- Work Planning and Prioritization
- Decision-making
- Teamwork and collaboration
- Scheduling and coordinating
- Cost control
- Team development
- Managing operations and efficiency
- Hiring and training
Awards
- Award winner for excellence, Shire HGT, 06/08
- Award winner for excellence, Shire HGT, 09/09
- Several awards winner for best performer, Amgen INC, Unknown
Conferences Certifications
- Leadership and High-Performance Coaching training, Application of Emotional intelligence in workplace, focused on High-performance and Coaching, Florida University, 05/19
- Numerous and ongoing verifiable Certifications and Continuing Education courses in HIV/AIDS counseling, testing, risk assessment, and management skills, Unknown, Unknown
Additional Skills Experience
- Experienced working with cell culture of mammalian cells such as CHO cells, MSC, Vero...CD34 isolation, stem cells...
- Knowledge of federal requirements for GMP manufacturing (21CFR 210,211) and Quality Systems (21CFR 820)
- Maxcyte, NC-200, Clinimacs, clarification...
- LIMS, LMR, C360, TrackWise…
- Served as Community Advisory Board member - HIV Vaccine Trials Network
Name
Hi, I’m
Personal Information
Title:
Languages
Spanish
Full Professional
French
Native or Bilingual
Portuguese
Professional Working
Timeline
Manufacturing Operations Site Manager
Vertex Pharmaceuticals
08.2022 - Current
Owner and founder
Djom Biosciences Consultant LLC
02.2022 - Current
Director of Manufacturing Operations
Performance Cell Manufacturing
10.2021 - 01.2022
Manufacturing manager
National Center for Therapeutics Manufacturing - FUJIFILM Diosynth
06.2021 - 10.2021
Cell Therapy manufacturing Supervisor
Catalent CGT
08.2019 - 06.2021
Manufacturing Team Lead Upstream
Lonza
11.2018 - 06.2019
Manufacturing Associate III
Amgen
08.2014 - 11.2018
Manufacturing Associate III, Shift Lead
Baxter Biosciences
05.2014 - 07.2014
Process Development Manufacturing Engineer Associate
Sanofi Pasteur
01.2013 - 09.2013
Biomedical Laboratory Supervisor
Upham's Corner Health Center
01.2010 - 01.2013
Manufacturing Technician, Cell Culture
Shire HGT
02.2008 - 01.2010
HIV/AIDS Service Manager
Upham's Corner Health Center
01.2007 - 02.2008
Community Health Educator (HIV/AIDS and STD)
Boston Medical Center
09.2004 - 01.2007
Executive MBA -
Quantic School of Technology and Management
B.S - Biomedical Laboratory and Clinical Sciences
Boston University
Bioethics: The Law, Medicine, and Ethics of Reproductive Technologies and Genetics -
Harvard Extension (Harvard Law School Online)
Medical Science Liaison Training Certificate -
Doctor of Organizational Leadership And Operations Strategy -
Northcentral University
No Degree -
University of Delaware
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