Summary
Overview
Work History
Education
Skills
Timeline
Generic

Samira Shore

St Louis

Summary

Dynamic and results-oriented professional with extensive experience in leadership roles, specializing in implementing strategic business plans that drive growth and enhance operational efficiency. Proven expertise in financial management and fostering strong stakeholder relationships to ensure alignment with organizational goals. Committed to collaboration and dedicated to cultivating high-performing teams, empowering talented individuals to achieve their full potential. Demonstrated success in navigating complex challenges while delivering measurable results.

Overview

13
13
years of professional experience

Work History

Founder, Consultant

Thriver Consulting LLC
  • I offer a range of pharmaceutical consulting services tailored to biologics, cell, and gene therapy, including but not limited to:
  • Drug Development Strategy – Guiding early-stage development with expertise in process optimization and scalability.
  • CMC (Chemistry, Manufacturing, and Controls) Consulting – Supporting manufacturing process development, scale-up, and tech transfer.
  • Manufacturing business model evaluation - from research/discovery through commercialization
  • Due Diligence & Partnering Support – Evaluating investment opportunities, collaborations, and partnership evaluations (CDMO, CRO, etc.)
  • My goal is to help organizations bring transformative therapies to patients efficiently and successfully.

Director, Technical Program Design

Thermo Fisher Scientific, Viral Vector Services, Commercial Operations
02.2021 - 05.2025
  • People Management
  • Build and maintain a group of Subject Matter Experts (SMEs) focused on providing technical solutions and options in viral vector development and production for clinical and commercial programs, regulatory filing strategy and CMC support with respect to viral vectors, platforms and systems.
  • Assign work, provide feedback, coaching and support career growth
  • Build and teach integrity
  • New Business Development
  • Assist Business Development in advancing new business opportunities by providing in-depth technical knowledge, regulatory consultancy and CMC support with respect to viral vectors, platforms and systems for producing them, analytical assays and testing for evaluating them, and cGMP facilities and equipment for manufacturing them to prospective client
  • Provide technical solutions and options that assist Clients in achieving their viral vector development, production requirements, clinical phase of development, regulatory filing strategy and business goals, whilst respecting their budgetary and timeline constraints, and as appropriate for all of the different classes of cell and gene therapies and different viral vector types.
  • Support the promotion of VVS’s technical expertise and services through active participation in Cell and Gene Therapy and biotechnology conferences, trade shows and exhibitions.
  • Build and maintain relationships with consultants, vendors, and other industry Subject Matter Experts to identify new viral vector production, manufacturing technologies or cell and gene therapy trends.
  • Support new Marketing initiatives and publication of scientific articles and white papers to raise the visibility of expertise and services.
  • Using expert technical knowledge, develop an understanding of the competitive landscape.
  • Development and Manufacturing Proposals and Scopes of Work
  • Assess client Requests for Proposals (RFP), participate in technical and strategic RFP discussions with the client, and design a technical scope of work for viral vector process development, pre-clinical production, clinical manufacture, process characterization, process performance qualification or commercial production that will achieve the client’s CMC development and manufacturing goals, minimize risk of failure during manufacture, whilst respecting their budgetary, and timeline constraints.
  • Review draft and final proposals and Scopes of Work to ensure that the technical scope hours allocated to perform these activities are aligned with Client expectations whilst:
  • Assisting Business Development in reviewing, understanding and presenting proposals to clients.
  • Assist with and provide answers to all technical follow-up information requests from clients as needed.
  • Participate in client site visits and prospective project discussions
  • Embody the technical “face” of VVS and provide industry influence through oral speaking engagements, and/or memberships in thought leadership groups and professional organizations around cell and gene therapies and viral vectors used for developing them
  • Provide Business with expert technical knowledge and leadership for new business / technology acquisition opportunities and initiatives.
  • Identify strategic opportunities for viral vector process development and manufacturing capability enhancement to increase win rate and business growth based on market direction, and customer requests.
  • Other
  • Develop and present to external groups include trade associations and scientific organizations.
  • Conferences, webinars, white papers, and others
  • Engage customers and operations staff for problem solving.
  • Responsible for working with operations, process development staff and quality for keeping technical track record and metrics up to date in format to go into site presentations
  • Remote

Senior Manager, Upstream Process Development

Thermo Fisher Scientific, Viral Vector Services
05.2019 - 02.2021
  • Participate in technical discussions with clients and Commercial operations team through project proposal stages
  • In some cases, travel to meet with clients and establish relationship
  • Provide technical input and assess regulatory requirements
  • Attend conferences
  • Technical lead and/or technical project lead for specific client projects
  • Oversee project from technical perspective from inception to GMP manufacturing
  • Serve as main contact to client and manage entire process: upstream, downstream, analytical development, GMP readiness and QC Assay qualifications
  • Review data and reports
  • Troubleshoot and provide technical support to maintain project timelines while keeping focus on process robustness and CQAs
  • Provide on-the-floor leadership and scientific mentorship
  • Provide technical leadership in developing new technologies in viral vector production
  • Define relevant operational/technical standards and practices for the site
  • Identify and drive implementation of improvements to maximize throughput and capacity utilization
  • Selecting, developing and leading a highly effective Upstream PD team to achieve set goals
  • Work closely with all teams in Process Development, Quality Assurance, and Operations to transfer new processes into the GMP environment including, batch record development, material sourcing, media and buffer planning and identifying and configuring new equipment and process rooms, as needed.
  • Lead a team of up to 20 personnel (Principal Scientists, Scientists, Lab Technicians and Coordinators)
  • Lead Upstream department with focus on safety, quality, delivery, people and cost
  • Recruit, interview and hire new employees
  • Establish CAPEX for all critical equipment and systems needed to support operations
  • Attend department and site leadership meetings for performance reviews
  • Maintain department metrics and ensure financial milestones are achieved
  • Seek out opportunities for innovation, growth of personnel, and process improvement
  • Participate and/or lead Kaizens as part of Thermo Fisher PPI initiative
  • Coaching, project management and collaboration
  • Empower, enable and motivate personnel to become strong leaders

Associate Director, Upstream Process Development

Brammer Bio
02.2018 - 05.2019
  • Design and transfer, optimize, scale-up, plan, statistical and data analyses of robust viral vector production processes
  • Technical lead and/or technical project lead for specific client projects
  • Design and execute experiments to optimize and broaden the platforms used in the manufacturing processes performed at Brammer
  • Provide on-the-floor leadership and scientific mentorship
  • Provide technical leadership in developing new technologies in viral vector production
  • Define relevant operational/technical standards and practices for the site
  • Identify and drive implementation of improvements to maximize throughput and capacity utilization
  • Responsible for drafting or reviewing development plans and reports
  • Selecting, developing and leading a highly effective Upstream PD team to achieve set goals
  • Work closely with all teams in Process Development, Quality Assurance, and Operations to transfer new processes into the GMP environment including, batch record development, material sourcing, media and buffer planning and identifying and configuring new equipment and process rooms, as needed.
  • Lead a team of up to 20 personnel (Principal Scientists, Scientists, Lab Technicians and Coordinators)
  • Lead Upstream department with focus on safety, quality, delivery, people and cost
  • Recruit, interview and hire new employees
  • Establish CAPEX for all critical equipment and systems needed to support operations
  • Attend department and site leadership meetings for performance reviews
  • Maintain department metrics and ensure financial milestones are achieved
  • Seek out opportunities for innovation, growth of personnel, and process improvement
  • Coaching, project management and collaboration
  • Empower, enable and motivate personnel to become strong leaders

Principal Scientist, Upstream Process Development

Brammer Bio
01.2017 - 01.2018
  • Technical Project Lead
  • Serve as technical liaison with client at core team and steering committee meetings, project manager (PM) specific to the project, and the project tech transfer team to elicit, clarify, and confirm all technical aspects for the project
  • Representing through consultation with a SME, the technical aspects of a project’s production process, raw material generation, and analytics, including quality target profiles (QTPs)
  • Collaborate with Tech Leads to ensure data is reviewed, including laboratory notebooks of project team members
  • Liaising with the client technical or CMC lead as needed
  • Attending sub-team and core meetings to ensure that all technical action items are addressed
  • Ensuring documentation and communication of any key project technical discussions, particularly technical decisions made, between Brammer and/or the client
  • Ensuring all technical decisions or action items for the project are completed in a timely fashion and to Brammer standards. This may involve elevating the decisions to the Core Team or Steering Committee.
  • Following the project from its inception through late stage process development including the development of both the process and analytics
  • Manage activities and communications across various departments to align with overall project timeline and goals
  • Maintain communication and relationship with the client
  • Review Development plan and all other critical documents/batch records
  • Project Lead
  • Oversee and execute all PD Upstream project activities
  • Participate in the incoming tech transfer process and evaluate project risks, raw material and equipment needs
  • Generate a development plan for establishment or development work per signed contract
  • Attend internal and core team meetings and provide project updates as needed
  • Participate in and ensure successful execution of experiments and production runs
  • Work closely with other departments and vendors to coordinate project needs
  • Generate PD production records and reports
  • Leadership and Management
  • Responsible for a team of scientists and lab technicians
  • Responsible for their development, training and professional advancement
  • Effectively leading by example as demonstrated by a hands-on approach to growth
  • Provide guidance and direction, empower and encourage effective communication
  • Process Development
  • Develop robust and scalable viral vector production processes
  • Identify and implement efficiency improvements for methods and equipment
  • Provide expertise with equipment and cell culture processes
  • Assist in and ensure successful technical transfer from PD to GMP
  • Technical and Scientific Expertise
  • Provide both hands-on and classroom training on all major equipment and processes
  • Troubleshoot excursions and provide solutions
  • Serve as Subject Matter Expert (SME) during client meetings, internal discussions and training exercises
  • Lead investigations resulting from equipment failures and/or process discrepancies

Technical QC Manager

FrontRange Labs
02.2016 - 11.2016
  • Review of laboratory data: BET, Sterility Testing, AET, Stability, Growth Promotion, MALDI, HPLC for identification and potency, verification/validation protocols, environmental monitoring
  • Equipment maintenance system: create new equipment SOPs, assign equipment numbers and enter info into database; preventative maintenance; IOPQ
  • Create, implement and provide training on new SOPs as needed
  • Review laboratory notebooks, batch books, log books
  • Perform QC checks as needed for a variety of testing with special emphasis on cleanroom operations
  • Serve as technical resource for laboratory activities, assure all lab testing aligns to current FDA and ISO regulations
  • Ensure all applicable internal/external quality and regulatory requirements (FDA & ISO 17025:2005) are fulfilled on an ongoing basis
  • Continually improving system, processes and services by identifying and implementing opportunities for improvements in all areas using quality system tools such as a basis (NCRs, CAPAs, Internal Audits, etc.)
  • Assist Quality Assurance team with Corrective and Preventative Action process, including failure investigations and root cause analysis
  • Assure robust training and education processes are implemented for QMS related policies and procedures
  • Project management: maintain and analyze stability study data generated in laboratory; manage experiment activities
  • Perform laboratory testing if needed
  • Supervise QC team

Cell Culture Process Development Scientist IV

Patheon Biologics (formerly Gallus Biopharm.)
06.2015 - 11.2015
  • Project lead
  • Create cell culture development plan
  • DOE for process establishment
  • Small-scale bioreactor, shake flask, and wavebag experiments
  • Procurement of raw materials and equipment
  • EHS evaluation
  • Attend internal and client meetings for project updates and progression
  • Build client relationships by providing exceptional and innovative quality work while maintaining essential communication
  • Create Technical Transfer Protocol for GMP manufacturing of developed process
  • Develop scalable and efficient cell culture processes in traditional and single use bioreactors
  • Responsible for developing mammalian cell culture based processes. Including, but not limited to: cell culture scaleup, media development, harvest (recovery) process development, process range finding and statistical analysis of data
  • Write standard operating procedures and test methods as needed
  • Prepare protocols and reports
  • Member of site Safety Committee
  • WIL “Women in Leadership” Group
  • Interviewed in www.teacherspayteachers.com/Store/Social-Studies-And-Stem

Cell Culture Scientist III

Gallus Biopharmaceuticals
08.2013 - 06.2015
  • Develop scalable mammalian cell culture processes in traditional and single use bioreactors
  • Design and execute DOE studies for upstream process development and optimization
  • Create batch records for bioreactor and pre-culture experiments along with media formulations
  • Draft technical transfer protocols to move processes from development to clinical and/or commercial production
  • Present data to clients through the generation of reports and preparing Microsoft Powerpoint presentation slides
  • Data analysis through implementation of appropriate databases
  • Act as technical resource and troubleshoot mechanical failures
  • Maintain and review laboratory notebooks
  • Attended and presented at SIMB 2014 Conference in St. Louis,MO
  • Participated in multiple Operation Excellence projects to improve lab organization, efficiency, and overall performance
  • Qualified trainer: perform instructor-led training on varying GMP and GLP SOPs related to cell culture processes

Cell Culture Scientist II

Gallus Biopharmaceuticals
06.2012 - 07.2013
  • Develop scalable mammalian cell culture processes in traditional and single use bioreactors
  • Design and execute DOE studies for upstream process development and optimization
  • Create batch records for bioreactor and pre-culture experiments along with media formulations
  • Draft technical transfer protocols to move processes from development to clinical and/or commercial production
  • Present data to clients through the generation of reports and preparing Microsoft Powerpoint presentation slides
  • Data analysis through implementation of appropriate databases
  • Act as technical resource and troubleshoot mechanical failures
  • Maintain and review laboratory notebooks
  • Attended and presented at SIMB 2014 Conference in St. Louis,MO
  • Participated in multiple Operation Excellence projects to improve lab organization, efficiency, and overall performance
  • Qualified trainer: perform instructor-led training on varying GMP and GLP SOPs related to cell culture processes

Cell Culture Scientist I

Gallus Biopharmaceuticals
03.2012 - 05.2012
  • Develop scalable mammalian cell culture processes in traditional and single use bioreactors
  • Design and execute DOE studies for upstream process development and optimization
  • Create batch records for bioreactor and pre-culture experiments along with media formulations
  • Draft technical transfer protocols to move processes from development to clinical and/or commercial production
  • Present data to clients through the generation of reports and preparing Microsoft Powerpoint presentation slides
  • Data analysis through implementation of appropriate databases
  • Act as technical resource and troubleshoot mechanical failures
  • Maintain and review laboratory notebooks
  • Attended and presented at SIMB 2014 Conference in St. Louis,MO
  • Participated in multiple Operation Excellence projects to improve lab organization, efficiency, and overall performance
  • Qualified trainer: perform instructor-led training on varying GMP and GLP SOPs related to cell culture processes

Education

Master of Biochemistry/Biotechnology -

University of Missouri St. Louis
St. Louis, MO
05.2012

Bachelor of Biological Sciences - undefined

Webster University
St. Louis, MO
05.2008

Skills

  • Detail-oriented, goal-driven team player with strong written and oral communication skills
  • Technical and operational expertise with viral vector process development utilizing various technologies (including full process development, characterization and manufacturing)
  • Data analysis
  • GMP and GLP
  • Familiar with general regulatory guidelines for gene therapies from preclinical to commercialization
  • Strong understanding of entire product lifecycle
  • Project management
  • Familiar with various viral vector production platforms: transient transfection, helper virus, stable production, Sf9/Baculovirus infection
  • Strive in dynamic and fast-paced work environment
  • Critical thinking and creativity
  • Strategic mindset and solution-focused
  • Team-oriented and collaborative approach
  • Leadership and management

Timeline

Director, Technical Program Design

Thermo Fisher Scientific, Viral Vector Services, Commercial Operations
02.2021 - 05.2025

Senior Manager, Upstream Process Development

Thermo Fisher Scientific, Viral Vector Services
05.2019 - 02.2021

Associate Director, Upstream Process Development

Brammer Bio
02.2018 - 05.2019

Principal Scientist, Upstream Process Development

Brammer Bio
01.2017 - 01.2018

Technical QC Manager

FrontRange Labs
02.2016 - 11.2016

Cell Culture Process Development Scientist IV

Patheon Biologics (formerly Gallus Biopharm.)
06.2015 - 11.2015

Cell Culture Scientist III

Gallus Biopharmaceuticals
08.2013 - 06.2015

Cell Culture Scientist II

Gallus Biopharmaceuticals
06.2012 - 07.2013

Cell Culture Scientist I

Gallus Biopharmaceuticals
03.2012 - 05.2012

Founder, Consultant

Thriver Consulting LLC

Bachelor of Biological Sciences - undefined

Webster University

Master of Biochemistry/Biotechnology -

University of Missouri St. Louis

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Samira Shore