Syner-G BioPharma Group

• Lead and personally execute biologics CMC consulting engagements, serving as the primary technical point of contact across program lifecycle • Provide expert guidance across biologics development including upstream and downstream process development, analytical characterization, drug substance and drug product manufacturing, and CMC regulatory strategy • Author and provide strategic input on CMC regulatory submissions including INDs, BLAs, and agency meeting packages • Maintain delivery accountability on engagements personally owned, holding the standard for quality and client satisfaction that defines the Syner-G reputation • Establish and grow Syner-G's presence in the West Coast biologics market, with particular focus on the Bay Area, San Diego, and Seattle biotech corridors • Leverage an existing network of biologics sponsor and CRO relationships to open doors, build pipeline, and position Syner-G as a credible biologics CMC partner • Collaborate with senior leadership on proposal development, pricing strategy, and scope definition for West Coast opportunities • Represent Syner-G at industry events, client meetings, and professional forums in the biologics space • Serve as a named resource in client proposals and scope-of-work documents, lending personal credibility to Syner-G's biologics capability narrative • Contribute to the build-out of Syner-G's West Coast team over time, including input on talent strategy and hiring for the region • Serve as a senior biologics resource across the national delivery organization, sharing expertise and supporting other consultants on complex programs • Provide leadership-level perspective on biologics market trends, client segment dynamics, and capability gaps that should inform Syner-G's service evolution

• Provide strategic leadership and oversight for projects spanning HVAC systems, facility infrastructure, commissioning, qualification, and operational readiness • Lead HVAC project execution activities across pharmaceutical manufacturing, laboratory, and support areas • Develop and manage project plans, schedules, budgets, resource strategies, and risk mitigation activities across multiple workstreams • Coordinate HVAC scope with construction, CQV, automation, facilities, and manufacturing teams • Oversee cleanroom implementation including airflow design, pressurization cascades, and environmental control strategies to meet GMP requirements • Manage contractors, vendors, schedules, field execution, and punch list activities through project completion • Drive HVAC startup, commissioning, qualification (IQ/OQ/PQ), and validation activities in alignment with CQV strategies • Support cleanroom and GMP facility readiness activities, including environmental monitoring alignment and operational setup • Perform and lead field walkdowns, system inspections, and issue resolution for HVAC and facility systems • Ensure delivery of key milestones, commissioning deliverables, validation packages, and turnover documentation • Guide development and execution of commissioning plans, qualification protocols, and turnover packages • Partner with CQV teams to ensure design and user requirements translate effectively into validation documentation and execution • Ensure alignment with engineering standards, safety requirements, and GMP expectations • Identify risks and drive mitigation strategies related to HVAC performance, contamination control, and facility operations • Track project deliverables, budgets, timelines, KPIs, and action items across all workstreams • Facilitate cross-functional meetings and communicate project status to leadership and stakeholders • Coordinate change controls, deviations, CAPAs, and documentation within quality systems (eQMS) • Support operational readiness and transition from construction and CQV into facility operations • Utilize systems such as CMMS, eQMS, LMS, and digital validation platforms; experience with KNEAT is a plus • Mentor and support project managers, engineers, and coordinators to ensure high quality execution and professional development

• Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides. • Perform characterization, stability testing, and process control strategies for oligonucleotide and peptide products. • Manage the transfer of phase appropriate analytical methods to trusted CDMO partners and draft all necessary comparability protocols. • Ensure all analytical activities comply with current regulatory guidelines (FDA, EMA, and, ICH). • Prepare and review regulatory submissions, including INDs and CTAs, with a focus on analytical methodologies. • Collaborate effectively with CMC teams; including, formulation scientists, drug substance scientists, quality assurance, and regulatory affairs. • Communicate analytical findings and strategies clearly to stakeholders, ensuring alignment on project goals. • Support all phases of clinical development by providing analytical insights and data to inform decision-making. • Participate in project meetings and contribute to the development of clinical trial materials. • Manage multiple projects simultaneously, ensuring timely delivery of analytical results while adhering to project timelines. • Mentor junior staff and provide guidance on analytical techniques and regulatory requirements.

• Design and develop stable formulations for high concentration subcutaneous dosage forms. • Assist clients with the appropriate experiments to optimize lyophilization processes, ensuring product stability and efficacy. • Manage the transfer of formulation design to trusted CDMO partners and draft all necessary comparability protocols to enable success. • Ensure all analytical activities comply with current regulatory guidelines (FDA, EMA, and, ICH). • Prepare and review regulatory submissions, including INDs and CTAs, with a focus on Drug Product. • Collaborate effectively with CMC teams; including, analytical development scientists, drug substance scientists, quality assurance, and regulatory affairs. • Communicate drug product gaps and development strategies clearly to stakeholders, ensuring alignment on project goals. • Support all phases of clinical development by providing formulation development and design to inform decision-making. • Participate in project meetings and contribute to the development of clinical trial materials. • Manage multiple projects simultaneously, ensuring timely delivery of formulation results while adhering to project timelines. • Mentor junior staff and provide guidance on formulation design and regulatory requirements.

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients • Handle FDA Type A, Type B, Type C and Type D meetings • Engage in all phases of drug development, from early-stage to post-registration • Develop and review regulatory documents, author IND, NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams • Assist clients with Non-Clinical and Clinical strategy and clinical development activities and design, draft submission documents, and review content for completeness and editorial quality • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines • Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement • Serve as the main point of contact for clients, ensuring effective communication and regulatory support • Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes • Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions • Partner with clients on Non-Clinical/Clinical strategy and submissions • Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities

• Oversee the preparation, review, and submission of Non-Clinical/Clinical regulatory documents for various clients. • Handle FDA Type A, Type B, and Type C meetings. • Engage in all phases of drug development, from early-stage to post-registration. • Develop and review regulatory documents, author NDA and BLA submissions, and coordinate with Non-Clinical/Clinical teams. • Assist clients with Non-Clinical/Clinical strategy, draft submission documents, and review content for completeness and editorial quality. • Manage and submit forms and documents globally, ensuring compliance with international and regional guidelines. • Lead meetings with FDA representatives, prepare briefing documents, and guide clients through regulatory requirements. • Conduct research, provide regulatory advice, and support marketing initiatives through blogs, white papers, and industry engagement. • Serve as the main point of contact for clients, ensuring effective communication and regulatory support. • Mentor and train new employees in regulatory affairs, Non-Clinical/Clinical, and FDA processes. • Facilitate the development, review, and resolution of comments on technically complex Non-Clinical/Clinical documentation for regulatory submissions. • Partner with clients on Non-Clinical/Clinical strategy and submissions. • Evaluate proposed manufacturing and quality changes for impact on existing registrations. • Manage regulatory communications for Non-Clinical/Clinical issues with the FDA and other global regulatory authorities.

• 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.