Legal Counsel - TMS

Overview

This role provides dedicated, day-to-day legal support for a contract manufacturing and radiopharmaceutical production services business unit.

The position supports the international roll-out of an approved prostate cancer imaging agent and helps advance a portfolio of late clinical-stage products addressing unmet need in oncology and rare diseases.

The role is calibrated as an entry-to-mid-level Counsel position. It has no direct reports and no strategic or team-leadership accountabilities.

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 issues related to current Good Manufacturing Practice (cGMP) compliance, including import/export requirements for radiopharmaceuticals and manufacturing-regulatory and facility compliance questions; escalate complex or novel matters to senior legal leadership.
• Handle contract disputes, warranty claims, quality-related matters, and service-level remediation issues at the first-line level, escalating material risks as appropriate.
• Develop, maintain, and improve contract templates, clause libraries, playbooks, and fallback positions for the manufacturing services business unit, working with the Legal Enablement function to drive consistency and efficiency.
• Coordinate day-to-day contracting matters with Operations, Quality, Procurement, Finance, and Commercial teams.
• 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, ARTMS commercial and isotope supply contracts, 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, including experience managing high-volume commercial contracting.
• Experience with manufacturing services agreements, supply chain contracts, quality agreements, or services contracting.
• Familiarity with current Good Manufacturing Practice (cGMP), Food and Drug Administration/Therapeutic Goods Administration manufacturing compliance, or pharmaceutical quality frameworks (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

• Experience that includes manufacturing services agreements, supply chain contracts, quality agreements, or services contracting.
• Familiarity with cGMP and FDA/TGA manufacturing compliance or pharmaceutical quality frameworks.
• Prior in-house experience.

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 employees located all around the world. The role supports an international business.

Equal Opportunity

The employer evaluates qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.