The Consultant II leads the regulatory review and risk assessment of promotional materials to ensure compliance with FDA, Health Canada, and PAAB standards. They act as a key partner to cross-functional teams to facilitate the compliant execution of brand strategies across various platforms.
Syner-G
28 Remote Job Openings at Syner-G
The Sr. Validation Engineer will lead validation activities for equipment, utilities, and computerized systems within GMP-regulated environments. They are responsible for authoring and executing validation documentation while providing technical mentorship to junior staff.
Lead validation activities for equipment, utilities, facilities, and computerized systems within GMP-regulated environments. Oversee the generation and execution of validation lifecycle documentation while providing technical mentorship to junior staff.
The Sr. Process Engineer will develop and implement a comprehensive terminal sterilization program, including defining cycle parameters and sterilization architecture. They will collaborate with cross-functional teams to support commissioning, qualification, and validation activities while ensuring regulatory compliance.
Lead validation activities for equipment, utilities, facilities, and computerized systems within GMP-regulated environments. Oversee the development and execution of validation lifecycle documentation while providing technical mentorship to junior staff.
Lead end-to-end recruitment efforts for India-based hiring, partnering with senior leadership to design and execute talent strategies. Drive the continuous improvement of recruitment practices, employer branding, and talent pipeline development across technical and business functions.
Lead the continuous improvement of enterprise applications and data platforms through business analysis, system administration, and governance. Develop reporting solutions and manage data integrations across platforms like Salesforce, NetSuite, and Power BI.
Act as the owner's representative for large, complex construction projects in lab or cGMP manufacturing environments. Manage the full project lifecycle from design through construction and commissioning, including supervising sub-contractors and managing building systems.
Support the technical planning, coordination, and execution of capital projects across facility and infrastructure initiatives. Coordinate with design firms, contractors, and internal teams to ensure projects are delivered safely and efficiently.
Serve as a strategic CMC leader and trusted advisor for pharmaceutical and biotechnology clients across all phases of drug development. Lead technical operations, manage CDMO relationships, and oversee the authoring of regulatory documents for global submissions.
Lead a portfolio of approximately 10 concurrent mAb drug substance technology transfer programs from process handoff through GMP manufacturing and PPQ. Establish governance, resource planning, and risk mitigation strategies to ensure technical readiness and commercialization success.
Lead the expansion of biologics delivery capabilities on the West Coast by driving client development and market credibility. Personally execute biologics CMC consulting engagements and provide expert guidance across the program lifecycle from development to regulatory submission.
The role involves generating and executing validation lifecycle documentation for equipment, utilities, and manufacturing processes to ensure regulatory compliance. It also includes supporting tech transfers, performing thermal mapping, and managing requalification activities.
Lead the planning and execution of integrated Verification and Commissioning & Qualification (C&Q) programs for large-scale GMP-regulated capital projects. Manage the full project lifecycle from design through operational handover, ensuring compliance with ASTM E2500 principles.
Author and manage regulatory documents such as Clinical Study Reports and protocols while leading document development efforts. Serve as a project owner by coordinating timelines and collaborating with cross-functional teams to ensure submission readiness.
The Validation Engineer is responsible for developing and executing validation protocols (FAT, SAT, IOQ, PQ) for processes, equipment, and facilities. They drive overall quality performance and compliance by maintaining the organization's validation program and supporting tech transfer projects.
Design and develop stable formulations for high concentration subcutaneous dosage forms and optimize lyophilization processes. Manage the transfer of designs to CDMO partners and prepare regulatory submissions such as INDs and CTAs.
Oversee the design, validation, and execution of analytical methods for oligonucleotides and peptides while managing transfers to CDMO partners. Collaborate with CMC teams to prepare regulatory submissions and ensure compliance with FDA, EMA, and ICH guidelines.
Provide advanced organizational and administrative support for construction and maintenance projects with a heavy focus on health and safety. Act as a facilitator between project managers, contractors, and stakeholders to ensure regulatory compliance and efficient project execution.
The role involves guiding clients through regulatory affairs, overseeing the preparation and submission of clinical and non-clinical documents to the FDA. Additionally, it entails leading the implementation of digital validation platforms like ValGenesis or Kneat within regulated pharmaceutical environments.
Lead GCP quality and compliance engagements for biopharma clients, overseeing CROs and vendors to ensure inspection readiness. Establish sponsor oversight programs, conduct GCP audits, and advise on regulatory strategy across the clinical development lifecycle.
The Vice President of Regulatory Partnerships will lead and expand strategic regulatory partnerships with a focus on post-approval lifecycle management and integrated client solutions. This role involves driving revenue growth, managing global teams, and ensuring operational excellence across regulatory consulting and service lines.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of new commercial fill-finish suites while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to ensure technical troubleshooting, process optimization, and strict adherence to GMP and regulatory standards.
The Sr. Fill-Finish Process Engineer will support the design, construction, and qualification of new commercial fill-finish suites while serving as a subject matter expert for aseptic manufacturing processes. They will collaborate with cross-functional teams to ensure technical troubleshooting, process optimization, and strict adherence to GMP and regulatory standards.
The Senior Process Engineer will lead process optimization for oral solid dose manufacturing and support technology transfer activities. They will troubleshoot complex process issues and collaborate with various teams to implement sustainable process improvements.
The Facilities Technician III is responsible for performing advanced maintenance activities and troubleshooting complex issues across multiple building systems. This role also includes supporting reliability and compliance requirements in laboratory, manufacturing, and utility environments.
This role involves leading the strategic planning, development, and execution of the company’s AI roadmap and long-term innovation strategy, focusing on identifying and prioritizing opportunities to improve operations and business value. Key functions include overseeing the entire AI development lifecycle, implementing responsible AI frameworks, building and mentoring a high-performing AI organization, and communicating complex technical insights to executive leadership.
The role involves providing regulatory consulting to a global pharmaceutical client, focusing on Chemistry, Manufacturing, and Controls (CMC) for post-approval products to ensure compliance with FDA, EMA, and global regulations. Key duties include leading the authoring and review of global CMC submissions, executing regulatory strategies, and coordinating responses to health authority questions.
