Legal Counsel - TMS

Overview

This role provides dedicated, day-to-day legal support for a contract manufacturing and radiopharmaceutical production services business unit. Responsibilities focus on execution-level contracting for manufacturing services agreements and related legal work supporting the production and delivery of clinical and commercial radiopharmaceutical products.

Responsibilities

• Draft, review, and negotiate manufacturing services agreements, master service agreements, quality agreements, supply contracts, statements of work, and change orders with third-party contract manufacturers and critical material suppliers.
• Identify and address current Good Manufacturing Practice (cGMP) compliance matters, including import/export requirements for radiopharmaceuticals, manufacturing-regulatory questions, and facility compliance issues; escalate complex or novel matters to the Assistant General Counsel, Global Operations.
• Handle contract disputes, warranty claims, quality-related matters, and service-level remediation issues at the first-line level, with appropriate escalation of material risks.
• Develop, maintain, and improve manufacturing solutions contract templates, clause libraries, playbooks, and fallback positions, working with Legal Enablement to drive consistency and efficiency.
• Coordinate day-to-day contracting matters with Operations, Quality, Procurement, Finance, and Commercial stakeholders.
• Use and improve approved intake workflows, escalation matrices, and contracting process tools to support high-volume manufacturing services contracting.
• Stay current on pharmaceutical manufacturing regulations, contract manufacturing industry practices, and relevant developments in quality and supply-chain law.
• Support broader operations needs, including procurement, commercial and isotope supply contracts, supply chain, logistics, distribution, and operational services arrangements as assigned.

Requirements

• Juris Doctor (JD) or Bachelor of Laws (LLB) or equivalent legal qualification; admitted or eligible to practice in the relevant jurisdiction.
• 6+ years of legal experience in commercial, manufacturing, supply chain, or transactional law, preferably in the pharmaceutical, biotechnology, medical device, or healthcare sectors.
• Strong contract drafting and negotiation skills, including experience managing a high volume of commercial contracting.
• Experience with manufacturing services agreements, supply chain contracts, quality agreements, or services contracting.
• Familiarity with current Good Manufacturing Practice, Food and Drug Administration/Therapeutic Goods Administration manufacturing compliance, or pharmaceutical quality frameworks is a plus.
• Prior in-house experience is preferred but not required; candidates from law firms with relevant life sciences transactional practices will also be considered.

Preferred Qualifications

• Experience supporting manufacturing-regulatory questions and facility compliance issues.
• Background across pharmaceutical quality frameworks and/or cGMP-related matters.

Compensation & Benefits

• Competitive salaries.
• Annual performance-based bonuses.
• Equity-based incentive program.
• Generous vacation.
• Paid wellness days.
• Support for learning and development.

Location

• Hybrid and remote work options are available, with employees located around the world.