Facilitator
Randy Peterson
Randy Peterson's Training:
Ph.D in neuroscience
MSc in molecular genetics
experienced in cGMP environments for biopharmaceutical manufacturing
MSc in molecular genetics
experienced in cGMP environments for biopharmaceutical manufacturing
Randy Peterson's Experience:
Stakeholder/Client Facing Engagement:
• Scope client needs, develop problem statements, and provide clear briefings to technical project personnel.
• Key internal “catcher” for all leads generated from the different touch-points from the various business units.
• Present overview of all CDMO services to potential clients during onsite, teleconference and external symposia and stakeholder meetings.
• Key point of contact for inbound services requests tasked with timely follow-up, engagement and project scoping.
• Responsible for issuing, assessing and initial review of confidential disclosure agreements.
• Engage potential clients, sourced potential projects while keeping a focus on corporate guiding strategic goals.
• Initiate and engage key industry partners for potential long-term strategic technical partnerships.
• Permanent member of all project management teams addressing external stakeholder projects with approval authority for all communications, change controls and extension of scope requests.
• Track project progression against stated timelines to ensure deliverables & key milestones are being met.
Internal/Corporate Accountabilities:
• Mapped out process workflows for revenue generating activities for the fee for service (FFS) activities across all business units, identifying all key decision points and functional team cross-over points.
• Member of internal Critical Action Team (C.A.T) tasked with assessing and addressing time-sensitive business opportunities or potentially harmful hazards.
• Established and maintained project, contracts and deal dashboards to enhance real-time revenue reporting at regular intervals.
• Drafted key template documents which captured critical information input needed by the various FFS workflows.
• Key stakeholder in the design and implementation of the Customer Relationship Management (CRM) software tool.
• Design team member to establish a legal contracts tracking software solution.
• Liaised with internal legal counsel on redline revisions of Confidentiality, Services and Master Services agreements.
• Weekly reporting and updating of revenue model and lead progression from initiation to contract finalization.
• Designed and launched client segmentation model for enhanced market intelligence & surveillance.
• Monthly reporting to internal project review and management board (PRMB) as well as to senior operation management (C-suite and VPs) on the real-time state of all projects across the different business lines.
Technical/Scientific Accountability:
• Technical and analytical Interpretation of client compendia or other reference Bioanalytical or Analytical methods to scope out project requirements.
• Present technical solutions to clients in proposals indicating cost timelines & resources with orthogonal scientific recommendations if applicable, to ensure regulatory compliance.
• Prepare complex proposals for larger projects with data from department Heads or Technical experts to meet client requirements.
• Serve as a subject matter expert for cell-based bioassay and cell-bank characterization & storage.
• Thorough knowledge of North American, European and international regulatory guidelines for biopharmaceutical and cell-based therapeutics.
Internal/Corporate Accountability:
• Ensure timely delivery of quotes and project scopes including anticipated pass-through costs.
• Ensure Confidential Disclosure Agreements (CDA) are in place prior to quote issuance.
• Ensure Quality & Master Services agreements are established and agreed upon prior to project initiation.
• Initiate and participate in client Out Of Specification (OOS) investigations and draft Corrective and Preventative Actions (CAPA).
• Interface with Quality Assurance Unit to ensure all regulatory guidance's are fulfilled and all experimental activities comply with the most current Good Manufacturing Practices (cGMP) guidelines.
• Monthly & quarterly financial reporting of all ongoing activities and accrual carryover against approved project budgeting.
Stakeholder/Client Facing Engagement:
• Lead project kick-off meetings and transcribe meeting minutes.
• Manage multi-site (continental and international) programs to ensure project milestones are meet and to the client’s satisfaction.
• Accountable for project tracking and milestone progression & delivery.
• Maintain clear concise and timely communication with clients and laboratory operations.
• Collaborate with Business development team and serve as a technical/Subject matter expert during onsite client meetings.
• Attend key conferences & Meetings to market our capabilities to potential clients.
• Scope client needs, develop problem statements, and provide clear briefings to technical project personnel.
• Key internal “catcher” for all leads generated from the different touch-points from the various business units.
• Present overview of all CDMO services to potential clients during onsite, teleconference and external symposia and stakeholder meetings.
• Key point of contact for inbound services requests tasked with timely follow-up, engagement and project scoping.
• Responsible for issuing, assessing and initial review of confidential disclosure agreements.
• Engage potential clients, sourced potential projects while keeping a focus on corporate guiding strategic goals.
• Initiate and engage key industry partners for potential long-term strategic technical partnerships.
• Permanent member of all project management teams addressing external stakeholder projects with approval authority for all communications, change controls and extension of scope requests.
• Track project progression against stated timelines to ensure deliverables & key milestones are being met.
Internal/Corporate Accountabilities:
• Mapped out process workflows for revenue generating activities for the fee for service (FFS) activities across all business units, identifying all key decision points and functional team cross-over points.
• Member of internal Critical Action Team (C.A.T) tasked with assessing and addressing time-sensitive business opportunities or potentially harmful hazards.
• Established and maintained project, contracts and deal dashboards to enhance real-time revenue reporting at regular intervals.
• Drafted key template documents which captured critical information input needed by the various FFS workflows.
• Key stakeholder in the design and implementation of the Customer Relationship Management (CRM) software tool.
• Design team member to establish a legal contracts tracking software solution.
• Liaised with internal legal counsel on redline revisions of Confidentiality, Services and Master Services agreements.
• Weekly reporting and updating of revenue model and lead progression from initiation to contract finalization.
• Designed and launched client segmentation model for enhanced market intelligence & surveillance.
• Monthly reporting to internal project review and management board (PRMB) as well as to senior operation management (C-suite and VPs) on the real-time state of all projects across the different business lines.
Technical/Scientific Accountability:
• Technical and analytical Interpretation of client compendia or other reference Bioanalytical or Analytical methods to scope out project requirements.
• Present technical solutions to clients in proposals indicating cost timelines & resources with orthogonal scientific recommendations if applicable, to ensure regulatory compliance.
• Prepare complex proposals for larger projects with data from department Heads or Technical experts to meet client requirements.
• Serve as a subject matter expert for cell-based bioassay and cell-bank characterization & storage.
• Thorough knowledge of North American, European and international regulatory guidelines for biopharmaceutical and cell-based therapeutics.
Internal/Corporate Accountability:
• Ensure timely delivery of quotes and project scopes including anticipated pass-through costs.
• Ensure Confidential Disclosure Agreements (CDA) are in place prior to quote issuance.
• Ensure Quality & Master Services agreements are established and agreed upon prior to project initiation.
• Initiate and participate in client Out Of Specification (OOS) investigations and draft Corrective and Preventative Actions (CAPA).
• Interface with Quality Assurance Unit to ensure all regulatory guidance's are fulfilled and all experimental activities comply with the most current Good Manufacturing Practices (cGMP) guidelines.
• Monthly & quarterly financial reporting of all ongoing activities and accrual carryover against approved project budgeting.
Stakeholder/Client Facing Engagement:
• Lead project kick-off meetings and transcribe meeting minutes.
• Manage multi-site (continental and international) programs to ensure project milestones are meet and to the client’s satisfaction.
• Accountable for project tracking and milestone progression & delivery.
• Maintain clear concise and timely communication with clients and laboratory operations.
• Collaborate with Business development team and serve as a technical/Subject matter expert during onsite client meetings.
• Attend key conferences & Meetings to market our capabilities to potential clients.
Randy Peterson's Experience with Online Groups:
As a technical client manager I held regular weekly virtual meeting between international sites with key stakeholders to get status updates and track deliverables and timelines