Syner-G BioPharma Group

Program Manager

• 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.

Senior Program Manager

Business Analyst

• 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

Content Writer

• 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.

Consultant I, Medical Writing

Artificial Intelligence

• 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

Senior Director, AI

Engineer

• 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.

Senior Process Engineer

Sales

• Lead territory and account strategy, including long-range planning, prioritization, and proactive outreach.
• Drive complex business development efforts including territory expansion, new client acquisition, and strategic account penetration.
• Generate new business opportunities through targeted prospecting, market research, and relationship development.
• Maintain a strong, qualified pipeline with consistent outreach, forecasting, and opportunity management.
• Serve as the primary relationship owner for high-value, multi-region accounts.
• Engage senior and executive-level client stakeholders through consultative and strategic discussions.
• Lead contract and rate negotiations, including MSAs, amendments, and commercial agreements.
• Coordinate cross-functional resources to ensure aligned execution, client satisfaction, and timely delivery.
• Prepare and deliver client-ready presentations, proposals, and supporting materials.
• Monitor competitive landscape, funding trends, and pipeline shifts to inform strategy.

Director, Sales

• Perform startup and commissioning of building and utility systems such as HVAC, chilled water, water systems, electrical systems, fire protection, pH neutralization, and waste systems.
• Generate and manage engineering lifecycle documentation, including impact assessments, URS/FRS documents, FAT/SAT documentation, ETOPs, and P&IDs.
• Conduct drawing walkdowns and verify field installation of equipment and utilities.
• Develop and execute commissioning protocols and reports.
• Support troubleshooting and issue resolution during commissioning and startup activities.
• Utilize systems such as BMS, PCS, and CMMS; experience with KNEAT is a plus.
• Coordinate with cross‑functional teams including engineering, facilities, operations, and quality to support project deliverables.

Senior Project Engineer

• Generate and execute validation lifecycle documentation (FAT, SAT, IOQ, PQ) for equipment, utilities, facilities, cleaning processes, shipping systems, and other GMP‑regulated assets.
• Support validation activities for internal and client tech transfer projects, including authoring, executing, reviewing, and closing validation documents such as risk assessments, validation plans, IQ, OQ, PQ, test methods, and validation reports.
• Write, review, and revise qualification and verification documents, including SOPs, master validation plans, execution plans, URS, FRS, design specifications, FAT documentation, verification protocols, and commissioning test procedures.
• Prepare summary reports for validation, verification, commissioning, and requalification activities.
• Develop and support procedures, investigations, protocols, reports, and change controls for Maintenance, Engineering, and Quality functions.
• Perform P&ID walkdowns to verify installation and system readiness.
• Conduct thermal mapping of temperature‑controlled chambers, warehouses, and SIP processes.
• Support resolution of regulatory observations, audit findings, and manufacturing site issues related to validation.
• Perform periodic reviews and requalification activities for temperature‑controlled systems and other validated assets.