GeneFab
Biotech
FractionalCorporateCounsel/SeniorContractsAttorney(CDMO)
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optimal for Senior candidates.
“Fractional Corporate Counsel / Senior Contracts Attorney (CDMO) at GeneFab. Skills: Contracts, M&A, IP, Corporate governance. Draft and negotiate contracts. Advise on M&A transactions”
Industry & Context.
Legal problem solving
What They're Looking For.
Must Have
5+ years contracts experience, Experience with M&A, Experience with IP, Experience with corporate governance
Nice to Have
Experience in CDMO, Experience in biotech, Experience in pharma
What You'll Do.
Draft and negotiate contracts
Advise on M&A transactions
Ensure corporate governance compliance
Provide legal counsel
Oversee regulatory compliance
How You'll Work.
Team & Collaboration
Cross-functional teams; Executive leadership
Communication Scope
Legal advice; Contract review
Full Job Description
## Key Responsibilities Commercial Contract Drafting & Negotiation 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. ## Key Responsibilities Cross-Functional Alignment & Quality Governance 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. ## Key Responsibilities Compliance & Contract Management Regulatory Watch: Ensure all agreements comply with relevant healthcare regulations, data integrity standards (ALCOA-plus), and advanced therapy classifications (such as ATMPs). Process Optimizatio
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