Top Biotech Operations & Support Jobs in Boston, MA

Lead CMC strategy and execution from early clinical development through commercial readiness. Oversee formulation, process development, scale-up, tech transfer, CDMO management, regulatory CMC submissions, quality systems, and GMP supply for Phase I/II development.

The Associate Director of Regulatory Affairs develops and executes regulatory strategies, manages submissions, collaborates with teams, and interacts with regulatory agencies to support organ transplantation programs.

Manage import/export compliance including HS and ECCN classifications, customs clearance, COO and FTA determinations; build SOPs and automated compliance checkpoints; collaborate with Product, Hardware, and Logistics on NPIs; monitor compliance metrics, IoR/EoR registrations, and EAR/ITAR risks; analyze data and report on trade compliance performance.

Lead clinical trial operations for Strand's clinical and preclinical programs, managing budgets, timelines, CROs, vendor oversight, regulatory interactions, QA/inspection readiness, site strategy, and a clinical operations team to ensure compliant, high-quality trial execution.

Lead and execute Ecolab's US government relations strategy for Life Sciences, coordinating state and federal advocacy (60% state/40% federal). Advocate before agencies (FDA, HHS) and state officials, manage lobbyists, develop PAC strategies, monitor legislation and regulations, provide executive advising, and represent Ecolab at industry forums and trade committees. Collaborate with commercial, regulatory, and global GR teams to advance business priorities and support growth.

Lead the pharmacovigilance team and oversee safety science strategies for oncology programs, manage interactions with health authorities, and mentor professionals in a high-performing safety organization.

The R&D Business Portfolio Strategy Lead advises on strategic alignment and decision-making for the Disease Unit, synthesizing complex data into actionable strategies and managing stakeholder engagements.

The Senior Director will lead biologics manufacturing innovations, drive technology transfers, and manage a global team while enhancing product performance and complying with regulations.

Provide front-desk support, manage office logistics and supplies, coordinate scheduling and travel, handle mail and vendor relationships, assist executives and cross-functional teams, and support employee events and internal communications.

Lead global supply chain logistics for small-molecule clinical and future commercial programs. Oversee import/export trade compliance, customs brokers, freight forwarders, 3PLs, warehousing, distribution, KPI reporting, budgeting, continuous improvement, and team development to ensure timely delivery to patients and regulatory compliance.