Legal Counsel - TMS

Overview

This role provides dedicated, day-to-day legal support for a contract manufacturing and radiopharmaceutical production services business unit. Responsibilities include execution-level contracting, drafting, negotiation, issue-spotting, and process improvement for manufacturing services agreements, quality agreements, supply contracts, and related contract-manufacturing matters that support the production and delivery of clinical and commercial radiopharmaceutical products.

The position is calibrated as an entry-to-mid-level Counsel role. There are no direct reports and no strategic or team-leadership accountabilities. Complex or novel matters are escalated to the Assistant General Counsel, Global Operations.

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 issue-spot 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 as appropriate.
• Handle contract disputes, warranty claims, quality-related matters, and service-level remediation issues at the first-line level, escalating material risks.
• Develop, maintain, and improve contract templates, clause libraries, playbooks, and fallback positions for contract manufacturing solutions, working with Legal Enablement to improve consistency and efficiency.
• Coordinate with Operations, Quality, Procurement, Finance, and Commercial teams on day-to-day contracting matters.
• 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 as assigned, including procurement, commercial and isotope supply contracting, supply chain, logistics, distribution, and operational services arrangements.

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, with experience managing a high volume of commercial matters.
• 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 preferred but not required; candidates from law firms with relevant life sciences transactional practices will also be considered.

Preferred Qualifications

• In-house experience.
• Demonstrated familiarity with pharmaceutical quality frameworks and manufacturing compliance (cGMP).

Compensation & Benefits

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

Location

• Hybrid and remote roles with employees located all around the world.
• Offices are located in Australia (HQ), Belgium, Japan, Switzerland, and the United States.