Fractional Corporate Counsel / Senior Contracts Attorney (CDMO)

GeneFab•Alameda, CA

5d•$200 - $300

About The Position

As a Contracts Counsel, you will serve as the primary legal partner driving the drafting, review, and supporting negotiation of the company’s commercial and operational agreements. Operating directly within the CDMO environment, you will bridge the gap between business objectives, complex manufacturing capabilities, and legal risk management. This role requires an intuitive understanding of life sciences transactions, intellectual property allocation, and the regulatory frameworks governing current Good Manufacturing Practices (cGMP).

Requirements

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.
Ability to balance legal risk mitigation with the commercial urgency of a fast-paced sales and manufacturing cycle.
Exceptional drafting precision and the ability to translate dense legal language into plain English for technical and operational teams.
Comfort working at the intersection of Business Development, Quality, Finance, and Plant Operations.

Responsibilities

Structure, draft, and support negotiation of complex MSAs and project-specific SOWs for drug discovery, process development, analytical testing, and clinical/commercial cGMP manufacturing.
Draft clear terms differentiating client Background IP, CDMO Background IP/Know-How, and Foreground IP generated during development or manufacturing.
Standardize and negotiate provisions regarding tech transfer success metrics, process-level commitments (vs. outcome guarantees), batch failure definitions, remedies, and limitations of liability.
Author and manage Non-Disclosure Agreements (NDAs), Material Transfer Agreements (MTAs), vendor agreements, capital equipment leases, and service contracts.
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.
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.
Provide clear, actionable legal advice to executive leadership, Business Development (BD), and project management teams regarding contractual obligations, risk exposure, and dispute resolution.
Ensure all agreements comply with relevant healthcare regulations, data integrity standards (ALCOA-plus), and advanced therapy classifications (such as ATMPs).
Maintain and continuously update corporate contract templates, playbook guidelines, and fallback positions to streamline the sales cycle.
Monitor active agreements for key milestones, renewals, price adjustments (e.g., inflation escalation clauses), and termination timelines.