Syner-G BioPharma Group

Business Analyst

• Play a leading role in supporting the continuous improvement of Syner G’s enterprise applications and data platform through business analysis, requirements definition, system administration, governance, integration development and reporting.
• Elicit, document, and maintain business, functional, and technical requirements for enterprise systems and data initiatives.
• Draft and maintain system and data architecture diagrams, data models, workflows, and related documentation.
• Partner with Sales, Delivery, Finance, and Operations to translate needs into requirements.
• Support solution design and delivery of dataflows, integrations, and reporting products.
• Manage user provisioning and role-based access across enterprise applications and data products.
• Troubleshoot system and data issues; coordinate resolution with internal teams and vendors.
• Support upgrades, enhancements, and data migration efforts.
• Support configuration, testing, environment management and update deployments.
• Document requirements for integration updates and modernization.
• Define current- and future-state integration processes, dataflows, and handoffs.
• Partner with internal and external vendors to develop and deliver enhanced system integrations.
• Develop native Kantata, NetSuite, and Salesforce reporting solutions to meet the needs of the business.
• Support the design, development and maintenance of centralized reporting in Power BI.
• Help develop and maintain semantic models for consistent metrics and definitions.

Senior Business Analyst

Program Manager

• Serve as a strategic advisor to senior leadership on SAP governance, program management, organizational readiness, and transformation initiatives.
• Establish and maintain SAP governance frameworks, decision-making processes, steering committee structures, and executive reporting mechanisms.
• Partner with executive stakeholders to define SAP program strategy, roadmaps, priorities, and success measures.
• Lead executive governance meetings, steering committees, and phase-gate reviews while facilitating key business and technology decisions.
• Develop and communicate executive-level presentations, dashboards, status reports, and decision-support materials.
• Provide oversight of large-scale SAP programs, including implementation, deployment, enhancement, and optimization initiatives.
• Identify program risks, dependencies, constraints, and opportunities; develop mitigation strategies and facilitate resolution of critical issues.
• Ensure alignment between business objectives, SAP capabilities, regulatory requirements, and enterprise strategies.
• Collaborate with functional and technical SAP teams to align workstreams, priorities, timelines, and resource requirements.
• Drive cross-functional stakeholder engagement across IT, Commercial, Supply Chain, Finance, Manufacturing, Quality, and Regulatory organizations.
• Advise leadership on organizational change management, business process transformation, and user adoption strategies.
• Monitor program performance and governance compliance through KPIs, scorecards, dashboards, and reporting mechanisms.
• Support portfolio management activities, including prioritization, funding recommendations, business case development, and executive decision support.
• Provide guidance on SAP best practices, ERP transformation methodologies, and enterprise governance standards.
• Champion continuous improvement initiatives focused on governance effectiveness, operational excellence, and program delivery performance.

Vice President

• 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

Vice President, Biologics

Project Manager

• 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

Senior Project Manager

Consultant

• 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.

Senior Consultant

• 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.

Consultant II

Compliance

• 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.

Principal Regulatory Affairs Consultant

Payroll

• Primary ownership of hourly payroll processing, ensuring employees are paid accurately and on time
• Lend expertise to exempt payroll processing as needed
• Contribute to active ADP system projects designed to enhance operations
• Support global expansion efforts, including payroll operations in India
• Own end-to-end processing of hourly/non-exempt payroll cycles with a focus on timeliness, accuracy, and compliance
• Validate timekeeping data, resolve discrepancies, ensure proper documentation for each pay period
• Respond to hourly employee payroll inquiries professionally
• Provide backup support for salaried/exempt payroll processing
• Participate in ADP system configuration, testing, and optimization projects
• Support payroll-related workstreams tied to international expansion
• Maintain payroll records in accordance with federal, state, and local regulations
• Support year-end processing, tax filings, audits, and ad hoc reporting as requested