Syner-G BioPharma Group

• Define project goals, scope, objectives, and deliverables in alignment with client requirements. • Lead and motivate project teams, ensuring clear communication, collaboration, and accountability. • Allocate resources effectively, manage project budgets, and monitor expenses to ensure costeffectiveness. • Identify potential risks and issues, develop mitigation strategies, and proactively address challenges to minimize project disruptions. • Maintain strong relationships with clients, vendors, and internal stakeholders, managing expectations and providing regular updates on project progress. • Ensure adherence to quality standards, review project documentation, and facilitate audits to maintain compliance with regulatory requirements. • Oversee the movement of materials, manage labeling processes, and ensure timely delivery of clinical supplies to support trial activities. • Drive process improvements, implement best practices, and seek opportunities to enhance project efficiency and effectiveness. • Prepare comprehensive project reports, documentation, and presentations for internal and external stakeholders.

• Independently establish and execute sponsor oversight programs for clinical trials, including CRO qualification, ongoing performance monitoring, and risk-based quality oversight aligned with ICH E6(R3) • Serve as the independent quality liaison between client sponsors and CROs, central labs, IRT/RTSM vendors, eCOA/ePRO providers, central imaging vendors, bioanalytical labs, and clinical supply CMOs • Author and approve quality agreements with clinical vendors; review and approve clinical vendor SOPs, validation documentation, and oversight plans before study start • Drive direction of the clinical quality function within client organizations — establish the quality oversight model, define escalation pathways, and align sponsor and vendor responsibilities • Independently plan, conduct, and report GCP audits, including investigator site audits, CRO/vendor system audits, TMF audits, clinical database audits, and for-cause audits • Lead pre-approval inspection (PAI) readiness and BIMO inspection preparation for sponsor clinical sites and key vendors; conduct mock inspections • Author audit reports with defensible findings, regulatory citations, and severity classifications; track CAPA commitments to closure • Build and maintain audit programs (risk-based audit plans, annual schedules, audit metrics) for client sponsors • Review and approve clinical trial documents prior to use — protocols and amendments, ICFs, IB updates, monitoring plans, data management plans, statistical analysis plans, and clinical study reports — for GCP compliance and inspection-readiness • Oversee TMF quality: review TMF completeness, contemporaneousness, and ALCOA+ compliance; advise on eTMF system configuration, indexing, and QC processes • Approve essential documents for clinical trial start-up, including site selection packages, regulatory submissions support documentation, and IRB/EC correspondence • Lead investigations into serious GCP issues including protocol deviations of significance, data integrity concerns, informed consent issues, IP accountability discrepancies, and suspected fraud or misconduct • Author and approve CAPAs arising from audits, inspections, and quality events; ensure effectiveness checks are designed and executed • Advise client sponsors on quality issue escalation, including determination of reportability to regulatory authorities and IRBs/ECs • Provide quality input on regulatory submissions — IND, IMPD, CTA, NDA/BLA/MAA clinical modules — and represent the quality function during regulatory authority interactions • Lead client inspection support during FDA BIMO, EMA, MHRA, or other Health Authority inspections of sponsors, sites, or vendors • Maintain current knowledge of evolving GCP regulations and guidance (ICH E6(R3), ICH E8(R1), FDA decentralized clinical trial guidance, EU CTR, ICH E2A/E2B, 21 CFR Parts 11/50/54/56/312/812) and translate changes into actionable client recommendations • Independently manage multiple concurrent client engagements; serve as the senior quality point of contact and represent Syner-G at client governance and steering committee meetings • Expand existing accounts by identifying additional quality gaps and proposing scope extensions; support proposal development and SOW authorship for new GCP work • Contribute to Syner-G's GCP service offering — develop reusable templates, audit checklists, training content, and thought-leadership materials.

• Conduct research and analysis to identify prospective accounts, key decision-makers, and emerging opportunities. • Apply independent judgment in tailoring outreach strategies (email, telephone, and digital platforms) to effectively engage prospective clients. • Collaborate with Marketing and Business Development Leads to design and refine campaign messaging that supports consultative selling. • Assist in evaluating market trends and client challenges to recommend approaches for positioning Syner-G as a solution provider. • Maintain Salesforce pipeline ownership at the entry level, ensuring accurate tracking, insight generation, and reporting of lead development activities. • Summarize findings from outreach efforts and provide strategic recommendations to Business Development Leads to inform ongoing market engagement. • Contribute to team discussions on lead generation tactics, offering insights from research and campaign outcomes.

• Guide clients through the development, installation, and execution of comprehensive Operational and Business Excellence programs. • Lead the delivery of a continuous improvement and organizational change framework. • Serve as a strategic partner to client leadership, contributing to organizational goals and transformation roadmaps. • Translate strategic objectives into actionable operational goals and structured improvement initiatives. • Support the definition and evolution of organizational structures, roles, and governance models.

• Develop and deploy holistic Procurement and Category Management structure for new construction projects. • Play a key role in contributing to the overall Procurement and construction goals for our clients. • Develop Procurement and Category management roadmap for multi-site project • Collaborate with internal and external stakeholders that interact with the program strategies and goals. • Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.

• We are seeking a highly skilled Business Analyst with strong technical acumen and deep life sciences domain expertise to support technology-driven business transformation initiatives • This role is responsible for designing scalable, flexible, and user-focused business capabilities by identifying, evaluating, and implementing systems and processes that enable business objectives in a cost-effective manner • The ideal candidate brings hands-on experience with Clinical Trial Management Systems (CTMS), a strong understanding of the software development life cycle, and the ability to translate complex business needs into actionable technical solutions • This position requires close collaboration with business stakeholders, developers, and vendors to deliver high-impact capabilities across the biotech ecosystem

• Lead the strategic planning, development, and execution of the company’s AI roadmap and long-term innovation strategy • Identify, evaluate, and prioritize AI and machine learning opportunities that improve operations, automation, and business value • Apply structured methodologies to assess use case feasibility, technical readiness, adoption requirements, and expected ROI • Partner with Data Engineering and Technology teams to build and deploy scalable AI models, generative AI capabilities, and decision intelligence tools • Oversee all stages of the AI development lifecycle, including model design, testing, deployment, monitoring, retraining, and performance optimization • Develop and manage responsible AI frameworks that address transparency, risk, ethics, compliance, and governance • Conduct impact analyses and assess organizational readiness to adopt AI-driven processes and technologies • Create and deliver communication strategies to support AI adoption for leaders, teams, and stakeholders • Collaborate with business units to map workflows, redesign processes, and integrate AI-driven solutions into operations • Lead the design and implementation of training programs that support end-user adoption of AI tools • Build, develop, and mentor a high-performing AI organization across data science, machine learning, and applied AI disciplines • Partner with external technology providers, vendors, academic institutions, and research organizations to evaluate emerging AI technologies • Create metrics and dashboards to measure activation, performance, and business impact of AI solutions • Lead continuous improvement efforts through data analysis, root cause assessment, and iterative solution updates • Communicate complex technical concepts and model insights to executive leadership in clear, accessible language • Manage AI program budgets, resources, vendor contracts, and reporting requirements

• Author a variety of regulatory documents, including Clinical Study Reports (CSRs), study protocols, and client submission materials. • Lead the development of complex modules (e.g., Module 2 summaries, Briefing Documents, Orphan Drug, Fast-Track, and Breakthrough Designation applications). • Apply quality control and submission-readiness processes to deliver high-quality documents within agreed client timelines. • Serve as a project owner by tracking timelines, adjusting schedules, and coordinating with clients to address evolving demands. • Plan for and anticipate project challenges, update visual timelines, and maintain adherence to deadlines. • Facilitate client interactions, including meetings, inquiries, and feedback discussions, while building and maintaining client trust. • Ensure consistency, accuracy, and alignment across documents with client updates and applicable regulatory standards. • Collaborate with cross-functional teams to ensure the quality and accuracy of regulatory documents. • Contribute to the development of regulatory strategies for early-stage and smaller clients. • Provide guidance on tools, document management systems, and client SOPs. • Engage in continuous learning through exposure to new document types, processes, and industry best practices under senior mentorship.

• Act as the primary SME for assigned cell therapy unit operations such as cell selection, gene transduction, cell expansion, and cryopreservation within cGMP manufacturing. • Provide Person-in-Plant (PIP) support during critical operations, ensuring real-time technical guidance and issue resolution. • Lead complex deviations and investigations to determine root causes and establish corrective and preventative actions (CAPAs). • Establish and maintain process control strategies for critical process parameters (CPPs) and critical quality attributes (CQAs). • Conduct data trending, process performance assessments, and modeling to identify improvement opportunities. • Propose and execute technical projects to optimize yields, reduce cycle times, and enhance process robustness and scalability. • Lead the development, optimization, and scale-up of manufacturing and laboratory processes across upstream, downstream, or formulation operations. • Oversee process automation initiatives, including equipment integration and implementation of advanced control strategies. • Lead commissioning, qualification, and startup of process equipment and automated systems. • Partner with automation, engineering, and operations teams to implement digital tools, process monitoring systems, and data-driven frameworks. • Troubleshoot high-impact equipment, process, and automation issues, providing technical direction to junior staff. • Lead technical transfer of manufacturing processes between development and manufacturing groups or across internal and external sites. • Ensure process consistency, scalability, and alignment with quality system expectations during transfer. • Author, review, and approve technical protocols, reports, memos, SOPs, and change control documentation. • Provide technical data and narrative content for regulatory submissions including IND amendments and CTA filings. • Support the evaluation, integration, and validation of new technologies or systems to ensure scalability, reliability, and operational readiness. • Work closely with Quality Assurance, Manufacturing Operations, Development, and Regulatory Affairs to align on technical strategies and execution plans. • Manage vendor relationships, equipment upgrades, and external technical partnerships. • Mentor and support junior engineers, providing technical coaching and oversight.

• Lead end-to-end project management activities related to the implementation of ValGenesis, Kneat, or similar electronic validation lifecycle management platforms • Conduct detailed analysis of client validation processes to document user requirements, functional specifications, system requirements, and workflow needs • Plan and facilitate stakeholder workshops, discovery sessions, and Conference Room Pilots (CRPs) to assess current-state validation processes and define future-state solutions • Configure ValGenesis or Kneat software to meet client-specific requirements including workflows, templates, user roles, and validation objects • Develop business requirements, configuration documents, user stories, and related documentation needed to support system implementation • Partner with Quality, Validation, IT, Engineering, and Manufacturing stakeholders to ensure alignment on system functionality, compliance requirements, and operational needs • Develop and support testing activities including unit testing, functional testing, regression testing, and user acceptance testing (UAT) • Troubleshoot system issues, track resolutions, and coordinate with technical teams to ensure timely remediation • Prepare training materials and lead end-user training sessions to support system adoption and change management • Support go-live readiness activities including cutover planning, migration validation, and hypercare support • Ensure implemented solutions align with GxP expectations, validation best practices, and regulatory standards • Provide ongoing support, guidance, and continuous improvement recommendations for validation system usage • Contribute to best practices, process standards, and knowledge sharing across the project team