Master Services Agreements (MSAs) & Statements of Work (SOWs): Structure, draft, and support negotiation of complex MSAs and project-specific SOWs for drug discovery, process development, analytical testing, and clinical/commercial cGMP manufacturing.
IP Allocation & Protection: Navigate intricate intellectual property boundaries. Draft clear terms differentiating client Background IP, CDMO Background IP/Know-How, and Foreground IP generated during development or manufacturing.
Operational Risk Allocation: Standardize and negotiate provisions regarding tech transfer success metrics, process-level commitments (vs. outcome guarantees), batch failure definitions, remedies, and limitations of liability.
Ancillary Agreements: Author and manage Non-Disclosure Agreements (NDAs), Material Transfer Agreements (MTAs), vendor agreements, capital equipment leases, and service contracts.
Quality Agreement (QAA) Alignment: Partner closely with Quality Assurance and Regulatory teams to ensure that commercial contract terms perfectly align with corresponding Quality Agreements, specifically resolving any conflicts regarding batch disposition, deviations, and audit rights.
Capacity & Tech Transfer Protection: Draft and enforce robust capacity reservation fees, cancellation/delay penalties, and raw material procurement obligations to protect the plant's operational schedule and cash flow.
Internal Advisory: Provide clear, actionable legal advice to executive leadership, Business Development (BD), and project management teams regarding contractual obligations, risk exposure, and dispute resolution.
Regulatory Watch: Ensure all agreements comply with relevant healthcare regulations, data integrity standards (ALCOA-plus), and advanced therapy classifications (such as ATMPs).
Process Optimization: Maintain and continuously update corporate contract templates, playbook guidelines, and fallback positions to streamline the sales cycle.
Contract Lifecycle Management: Monitor active agreements for key milestones, renewals, price adjustments (e.g., inflation escalation clauses), and termination timelines.
Business Acumen: Ability to balance legal risk mitigation with the commercial urgency of a fast-paced sales and manufacturing cycle.
Communication: Exceptional drafting precision and the ability to translate dense legal language into plain English for technical and operational teams.
Collaborative Mindset: Comfort working at the intersection of Business Development, Quality, Finance, and Plant Operations.
Juris Doctor (JD) degree from an accredited law school.
Active, good-standing license to practice law in the relevant state jurisdiction (or eligible for immediate registration as In-House Counsel).
Minimum 3–6 years of experience practicing law, with a heavy emphasis on commercial contracts within the life sciences CDMO industry.
Proven track record of negotiating complex service or supply agreements from the service-provider/vendor perspective (highly preferred) or the sponsor perspective.
Deep understanding of the functional difference between a traditional CMO contract (supply-focused) and a CDMO contract (hybrid development, process optimization, and supply).
Strong working knowledge of intellectual property law as it applies to bioprocesses, platform technologies, and derivative improvements.
Familiarity with cGMP manufacturing regulations, FDA inspection profiles, and the chemistry, manufacturing, and controls (CMC) project lifecycle.