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.
Syner-G
22 Remote Job Openings at Syner-G
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.
Lead and oversee complex HVAC, facility, and validation initiatives within GMP regulated life sciences environments. Manage cross-functional teams to drive cleanroom implementation and ensure alignment with regulatory expectations and client requirements.
The Revenue Accountant manages revenue recognition, billing, and accounts receivable in compliance with ASC 606. This role involves reviewing customer contracts and collaborating with cross-functional teams to ensure financial accuracy and operational efficiency.
Guide clients through regulatory affairs and compliance to facilitate the successful development and approval of pharmaceutical products. Oversee the preparation and submission of clinical regulatory documents and manage communications with the FDA and global authorities.
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 Sr. Revenue Accountant is responsible for ensuring accurate revenue recognition and billing in compliance with ASC 606 for complex consulting arrangements. This includes managing accounts receivable, performing monthly reconciliations, and partnering with cross-functional teams to resolve contractual and invoicing issues.
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.
Oversee project execution with a focus on clinical supply operations, including managing goals, budgets, and resource allocation. Lead project teams and maintain strong relationships with clients and vendors to ensure timely delivery of clinical supplies.
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.
