Jobs at Forge Biologics

Develops, optimizes, validates, and executes protein-based assays supporting AAV gene therapy products. Responsibilities include troubleshooting, data analysis, assay transfer, quality control, regulatory documentation, mentoring junior staff, project planning, and continuous process improvement in laboratory and cGMP environments.

The Senior Associate Scientist leads scientific and technical documentation projects across QC functions, including SOPs, protocols, and reports. Responsibilities include coordinating with subject matter experts, managing cross-functional documentation projects, updating materials for method qualification and change controls, reviewing quality and consistency, identifying documentation gaps, mentoring junior associates, and administering Veeva Vault processes.

Supports downstream process development for AAV purification under supervision. Performs foundational purification activities including buffer preparation, filtration, chromatography, buffer exchange, clarification, equipment sanitization, and monitoring. Documents experiments, analyzes data, prepares reports and presentations, follows safety and cGMP requirements, and collaborates with cross-functional teams in a laboratory environment.

Leads the Document Control team within QA Operations, overseeing controlled document issuance, revision workflows, records management, eQMS administration, change controls, metrics, and inspection readiness. Manages team performance, training, and development while partnering with manufacturing, quality, laboratory, and cross-functional stakeholders. Drives documentation process improvements, supports system validation and upgrades, and ensures compliance with GMP requirements and regulatory expectations.

Applies statistical methods to bioanalytical assay development, qualification, validation, and stability studies. Performs analyses involving linearity, accuracy, precision, detection limits, trend analysis, control charting, and regression. Supports statistical analysis plans, regulatory documentation, investigations, and root cause analyses while collaborating with QC, Analytical Development, Process Development, and Regulatory teams in a GxP-regulated biopharmaceutical environment.

Supports biopharmaceutical equipment and process implementation, technology transfer, engineering studies, commissioning and qualification, troubleshooting, technical documentation, investigations, and manufacturing readiness for gene therapy operations. Collaborates with Process Development, Manufacturing, Validation, Quality, vendors, and other stakeholders to ensure scalable, robust, compliant processes and equipment.

Develops and qualifies protein-based assays for AAV gene therapy products. Responsibilities include designing experiments, optimizing and troubleshooting methods, performing analytical testing, interpreting data, supporting assay transfers and validation, preparing technical documentation, collaborating cross-functionally, and maintaining laboratory safety and compliance. The role also involves mentoring junior team members and contributing to process improvements and regulatory documentation.

Leads and supports capital engineering projects from feasibility through design, construction, startup, and turnover at a regulated biologics manufacturing site. Manages scope, schedules, budgets, contracts, vendors, documentation, risk assessments, change control, construction oversight, equipment procurement, and operational readiness. Partners with PMO, Plant Engineering, Maintenance, contractors, and cross-functional teams to ensure compliant, high-quality project execution.

Supports quality assurance for cGMP AAV gene therapy manufacturing. Responsibilities include cleanroom QA oversight, batch record and controlled-document review, personnel training, deviation and CAPA support, SOP updates, continuous improvement, and audit or inspection preparation. The role collaborates with manufacturing, process development, and analytical development teams while communicating quality issues and maintaining regulatory compliance.

Performs cGMP analytical testing for AAV vectors, plasmids, and cell banks, including in-process, release, stability, qualification, and validation assays. Acts as a subject matter expert in nucleic acid, protein, or cell-based methods; troubleshoots assays; supports investigations, deviations, CAPAs, audits, and inspections; authors and reviews QC documentation; analyzes and trends data; and mentors junior staff.