Overview
This role provides dedicated, day-to-day legal support for a contract manufacturing and radiopharmaceutical production services business unit (“Manufacturing Solutions”). Responsibilities focus on execution-level contracting, drafting, negotiation, issue-spotting, and process improvement for manufacturing services and related agreements.
The position is calibrated as an entry-to-mid-level Counsel role with 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 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.
- 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 Manufacturing Solutions, partnering with Legal Enablement to drive consistency and efficiency.
- Coordinate with Operations, Quality, Procurement, Finance, and Commercial teams on day-to-day contracting matters for Manufacturing Solutions.
- 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 operational 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 industries.
- Strong contract drafting and negotiation skills, including experience managing high-volume commercial work.
- Experience with manufacturing services agreements, supply chain contracts, quality agreements, or services contracting.
- Familiarity with current Good Manufacturing Practice and 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
- Experience covering manufacturing-regulatory questions, facility compliance issues, import/export requirements for radiopharmaceuticals, and related quality and supply-chain contracting.
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.