Summary
Overview
Work History
Education
Skills
Work Availability
Quote
Work Preference
Software
Timeline
References
Personalbrandstatement
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Gina Kamins

Gina Kamins

Westfield,NJ

Summary

Experienced professional with nearly 30 years of expertise in change management, process improvement, and efficiency within the pharmaceutical industry. Seeking a leadership role in a dynamic organization that values entrepreneurship. Skilled in coaching and mentoring high-performing teams. Eager to join a job that focuses on evaluating current processes and actively seeks opportunities for improvement and evolution. Consistently implemented innovative processes that positively impacted profit margins, efficiency, and quality. Proven ability to win over stakeholders and successfully promote new methodologies.

Overview

27
27
years of professional experience

Work History

Director, Global Process Owner GxP Global Management Review

Bristol-Myers Squibb
04.2022 - 02.2024
  • Develop/Implement/Maintain/Improve procedural documentation and associated training (SOP, Work Instruction, Job Aides and Templates)
  • Manage team responsible for process oversight, including Community of Practice aimed at driving harmonization across 60+ active quality councils worldwide.

Director, Global Quality Systems

Bristol-Myers Squibb
04.2020 - 04.2022
  • Owned the Quality Manual for Medical Devices.
  • Partnered with technical SMEs to identify and drive continuous improvement initiatives aimed at improving and maintaining global regulatory compliance of systems and processes related to Medical Device design, development, commercialization and beyond.
  • Served as Lead for the Med Device Quality Council
  • Served as Device Quality representative on several global corporate integration and optimization initiatives including Document Management, Risk Management, Design Controls, MDR optimization, Corporate Rebranding, Commercial Labeling Optimization, and Quality Council.
  • Participated as Quality SME on audit and inspection response team.
  • Lead cross functional teams responsible for evaluation and action identification associated with emerging and changing global regulations, including EU MDR 2021.

Director, Development Systems

Celgene Corp.
10.2018 - 04.2020
  • Served as Quality Systems Expert within the Biologics organization, ensuring compliance as we transitioned from being a predominantly “virtual” organization (relying on third party labs) to a clinical GMP manufacturing and testing facility.
  • Provided Systems and Process oversight during the compilation of technical documentation for Reblozyl BLA submission and developed an “umbrella” change control approach, leading and monitoring execution of action plans in preparation of commercial launch.

Associate Director, Global Quality Systems

Celgene Corp.
06.2017 - 10.2018
  • Managed a team of Business Process Owners responsible for Deviations/CAPA/Logistics, Clinical and Commercial Product Quality Complaints, and Global Change Management
  • Approved all the SDLC deliverables for my team, including User Requirements Specifications, User Acceptance Testing Scripts (UAT), Global Standards, Procedures (SOP/WP) and Training materials
  • Represented all Global Quality Systems (including doc control, training, BEMS, LIMS, ERP and MES) for projects, acquisitions and integrations:
  • Participated as a member of the Steering Committee
  • Lead onboarding activities for projects, affiliate and acquired organizations:
  • Worked with SMEs and IT to assess and document cost estimates related to license/system/process changes
  • Gathered and maintain list of deliverables, for all systems and tracked based on target dates
  • I was the GMP Quality lead for integration of Juno Therapeutics, serving as the central point of contact overseeing of all aspects of global GMP Quality including audits, operations, systems, master data, procedures and policies
  • I received a written commendation and monetary award from the CEO for my leadership efforts related to this project.

Senior Manager, Global Quality Systems- Business Process Owner Global Change Management

Celgene Corp.
10.2015 - 06.2017
  • Had oversight of SDLC activities related to the module, identifying enhancements, addressing defects, collaborating with stakeholders to perform risk/benefit analysis, defining priorities, and managing budgeted dollars.
  • Owned procedural and training documentation, ensuring everything aligned with global regulatory requirements.
  • Monitored performance of the process, reporting metrics to Global Management Review.
  • Trained global sight personnel and provided support during inspections as needed

Senior Manger, QA Operations, Development- Change Management

Celgene Corp.
08.2013 - 10.2015
  • Promoted and tasked with creating a change control process for Development (IND to NDA/BLA):
  • Lead a team of cross functional executives to define scope and requirements
  • Created procedures and tools to ensure consistent change management process
  • Once the preliminary process was in place, I partnered with Cell Therapy (CTDO) and Commercial Change Control stakeholders globally to streamline workflows and create a single standardized process for use across Development, Commercial and CTDO.
  • Oversaw all business-related SDLC deliverables.
  • Created a role-based training curriculum structure and a systematic approach to training and system access requests.
  • Provided quarterly metrics to management
  • Used the system to generate annual summary reports by compound for distribution to CMC team members.
  • Supported Exec
  • Director of Development Quality:
  • Monitored department training compliance.
  • Represented DQ as a member of global quality employee satisfaction survey response team
  • Administered the department’s SharePoint team site, responsible for design, content, training and access
  • Coordinated department meetings
  • Created and documented a systematic approach to performing GMP Inspection Documentation Coordinator role during HA inspections

Manager, QA Operations, Analytical Support

Celgene Corp.
10.2010 - 08.2013
  • Serve as final QA approver on all GMP documentation generated by the QC and AR&D laboratories and Metrology including SOPs/WPs, analytical methods, change controls, specifications, reference standard qualification reports and purity statements, protocols and reports (validation; transfer, vendor documents, deviations, equipment and software IQ/OQ/PQ, traceability matrices etc)
  • Represented business QA in LIMS design and implementation team

Associate Manager, QA Document Control

Celgene Corp.
11.2007 - 10.2010
  • Served as System Owner for LiveLink-based global doc management system (eRexS).
  • Managed a staff of 4 FTEs
  • Oversaw SDLC activities related to the system, identifying enhancements, addressing defects, collaborating with stakeholders to perform risk/benefit analysis, defining priorities, and managing budgeted dollars.
  • Owned procedural and training documentation, ensuring everything aligned with global regulatory requirements.
  • Monitored performance of the process, reporting metrics to Global Management Review.
  • Mentored global sight personnel and provided support during inspections as needed
  • Lead a team that served as first tier support for all system-related HelpDesk Tickets
  • Implemented and Lead User-Group community, facilitating monthly meetings to share news and coordinate cross-functional discussions
  • Lead the system’s Steering Committee and Senior Management Governance Committee
  • Developed and managed role-based training curricula and user account management process
  • Oversaw day to day activities related to the storage, archival, and retrieval of paper documentation including laboratory notebooks, logbooks, protocols, reports, batch records, and vendor documentation.
  • Designed and implemented electronic inventory system and layered on a formal e-ticket system for tracking of requests.

Sr. QA Specialist, Quality Operations

Celgene Corp.
01.2007 - 11.2007
  • Reviewed and/or approved laboratory related documents such as deviations, OOS, methods, specs, IQ/OQ/PQ protocols and reports, SOPs, Change Requests, Protocols, Reports.
  • Performed batch record review/release for clinical supplies
  • Generated Certificates of Analysis and Purity Statements and Certificates of Conformance for non-Clinical
  • Served as Administrator for Training system (ComplianceWire)

Scientist, Quality Assurance- Documentation

Ortho-McNeil
08.2005 - 12.2006
  • Responsible for writing and reviewing Annual Product Reviews (internal documents) and Stability Reports for inclusion in the CMC section of the annual reports for marketed drug products.
  • Partner with Regulatory Affairs to address scientifically critical issues such as those resulting in Field Alerts and Stability Alerts.
  • Assist in audits (FDA and Internal).

Scientist, Quality Assurance- Analytical Development

Ortho-McNeil
08.2003 - 07.2005
  • Developed and validated HPLC method for potent, dual-active oral contraceptive tablets
  • Provided urgent technical justification of method changes for presentation to FDA during GMP inspection resulting in the avoidance of a Warning Letter
  • Served as Millennium Administrator for Analytical Development Group; designed and lead multiple training sessions and created step-by-step instructional reference guides
  • Represented PSGA on several ANGs (Analytical Networking Groups) whose goal is to drive innovation and uniformity in analytical methodologies across all companies in J&J
  • Served as Super-User for Documentum
  • Served as a technical mentor to individual analysts throughout the department

Associate Research Scientist II

Bristol-Myers Squibb
08.2001 - 07.2003
  • Successfully completed dissolution support for Biowaiver of new product formulation
  • Collaborated with BMS statisticians to arrange a three-part training series for all AR&D scientist in various statistical methods, including Design of Experiments (DOE) for use in method development and validation
  • Utilized DOE to determine effect and interactions of various method parameters and tablet coloring agents on the formation of disulfide observed during dissolution
  • Evaluated NIR for quantitative analyses (e.g
  • Assay and content uniformity) of solid dosage forms
  • Presented overview and experimental summary to team and created poster for EAS and PittCon
  • Participated on team responsible for the preparation of NDA Validation Report Model Document Template
  • Prepared instructional handouts for the use of Millennium software for dissolution module
  • Completed User Acceptance Testing of MISL (Millennium Interface w/ SQL-LIMS)
  • Co-developed HPLC method for analysis of DSE samples in complex matrix (i.e
  • Labrafil)
  • Performed Cleaning Verification Studies

Associate Research Scientist I

Bristol-Myers Squibb
04.2000 - 08.2001
  • Prepared formal “Gold Standard” Validation Report for NDA filing
  • Participated in the Bristol-Myers Squibb Communities of Science (Capillary Electrophoresis and Reversed Phase Chromatography); Lead “novel column technologies” sub-group
  • Participated on several Best Practices teams (HPLC and Dissolution)
  • Involved in early methods development (purity/impurity and dissolution) in support of pre-IND studies
  • Evaluated new technology for development of dissolution method for novel gastric-retentive formulation (USP Apparatuses 1 - 4)
  • Presented several posters of developmental work at interdepartmental meetings

Assistant Research Scientist II

Bristol-Myers Squibb
11.1998 - 04.2000
  • Performed Reversed and Normal Phase Chiral method development studies for drug substances, drug products and intermediates
  • Managed departmental containment room
  • Prepared technology transfer documents (protocols and reports) for method transfer to domestic and international BMS manufacturing and QC sites
  • Performed “Gold Standard” Validation experiments for drug substance purity/impurity method
  • Developed and validated automated dissolution method with HPLC finish (Alliance-D with Distek)
  • Supervised technical staff

Assistant Research Scientist I

Bristol-Myers Squibb
05.1998 - 11.1998
  • Developed and validated several Gradient RP-HPLC purity/impurity methods for drug substances, drug products and intermediates
  • Documented all experiments and results in accordance with GMP standards
  • Authored test methods and validation reports

Assistant Research Scientist I

Bristol-Myers Squibb
09.1996 - 05.1998
  • Designed and implemented sample/reagent storage facility and tracking system
  • Performed mammalian cell culture (including automated bioreactors)
  • Monitored cell growth and antibody production (e.g
  • HPLC, Kodak Biolyzer, ELISA, and SDS-PAGE)
  • Developed and validated analytical methods (SDS-PAGE and IEF gel electrophoresis)
  • Analyzed sample (via SDS-PAGE, IEF, ELISA, Western Blot, and fluorometric wash assay)
  • Received training on antibody purification via perfusion chromatography
  • Handled small animals
  • Immunization
  • Blood sampling (retro-orbital bleed) and analysis
  • Spleenectomy and cell fusion

Education

BS Biochemistry -

Virginia Tech
Blacksburg, Virginia
05.1996

Certificate - Current Good Manufacturing Practices Certified Professional (GMPCP)

CfPIE
08.2020 - 08.2020

Certificate - Quality Systems Regulation Certified Compliance Professional (QSRCP)

CfPIE
08.2020 - 08.2020

Skills

  • Strategic Planning
  • Verbal and written communication
  • People Management
  • Operations Management
  • Team Management
  • Creativity and Innovation
  • Project Coordination
  • Organizational Development
  • Budget Management
  • Issues Resolution
  • Hiring and Retention
  • Charismatic Leader
  • Business Development
  • Regulatory Compliance
  • Talent Acquisition
  • Content Development
  • Teamwork and Collaboration
  • Team Leadership
  • Relationship Building
  • Decision-Making
  • Process Improvements
  • Staff training/development
  • Customer Service
  • Performance Evaluation and Monitoring
  • Continuous Improvement
  • Quality Assurance
  • Change Management
  • Training Management
  • Performance Improvements
  • KPI Tracking
  • Records Organization and Management

Work Availability

monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote

Intelligence is the ability to adapt to change.
Stephen Hawking

Work Preference

Work Type

Full Time

Work Location

RemoteHybridOn-Site

Important To Me

Work-life balanceCompany CultureHealthcare benefits401k matchStock Options / Equity / Profit SharingPaid time offPaid sick leaveWork from home option

Software

Veeva

Adobe

Excel

Word

PowerPoint

OneNote

MS Teams

MS Forms

Documentum

LiveLink

SurveyMonkey

ComplianceWire

Tableau

SharePoint

Timeline

Director, Global Process Owner GxP Global Management Review

Bristol-Myers Squibb
04.2022 - 02.2024

Certificate - Current Good Manufacturing Practices Certified Professional (GMPCP)

CfPIE
08.2020 - 08.2020

Certificate - Quality Systems Regulation Certified Compliance Professional (QSRCP)

CfPIE
08.2020 - 08.2020

Director, Global Quality Systems

Bristol-Myers Squibb
04.2020 - 04.2022

Director, Development Systems

Celgene Corp.
10.2018 - 04.2020

Associate Director, Global Quality Systems

Celgene Corp.
06.2017 - 10.2018

Senior Manager, Global Quality Systems- Business Process Owner Global Change Management

Celgene Corp.
10.2015 - 06.2017

Senior Manger, QA Operations, Development- Change Management

Celgene Corp.
08.2013 - 10.2015

Manager, QA Operations, Analytical Support

Celgene Corp.
10.2010 - 08.2013

Associate Manager, QA Document Control

Celgene Corp.
11.2007 - 10.2010

Sr. QA Specialist, Quality Operations

Celgene Corp.
01.2007 - 11.2007

Scientist, Quality Assurance- Documentation

Ortho-McNeil
08.2005 - 12.2006

Scientist, Quality Assurance- Analytical Development

Ortho-McNeil
08.2003 - 07.2005

Associate Research Scientist II

Bristol-Myers Squibb
08.2001 - 07.2003

Associate Research Scientist I

Bristol-Myers Squibb
04.2000 - 08.2001

Assistant Research Scientist II

Bristol-Myers Squibb
11.1998 - 04.2000

Assistant Research Scientist I

Bristol-Myers Squibb
05.1998 - 11.1998

Assistant Research Scientist I

Bristol-Myers Squibb
09.1996 - 05.1998

BS Biochemistry -

Virginia Tech

References

References available upon request. Refer to LinkedIn Profile and review recommendations:  HYPERLINK "http://www.linkedin.com/in/gina-kamins-5282694" www.linkedin.com/in/gina-kamins-5282694

Personalbrandstatement

I am an energetic, approachable, and collaborative individual who enjoys working cross functionally to identify opportunities for improvement and leading teams to brainstorm, develop, design, prototype, test and implement compliant, intuitive, and efficient ways of working.

References

References available upon request. Refer to LinkedIn Profile and review recommendations:  HYPERLINK "http://www.linkedin.com/in/gina-kamins-5282694" www.linkedin.com/in/gina-kamins-5282694

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