Overview
The Assistant General Counsel will be a senior member of the U.S. Legal Department responsible for supporting the commercial manufacturing business. This role involves leading the drafting, review, negotiation, and strategic management of complex commercial supply agreements related to the development, manufacture, and commercial supply of active pharmaceutical ingredients (API) and finished pharmaceutical products. The attorney will serve as a principal legal advisor to commercial manufacturing teams and collaborate with Business Development, Operations, Technical Services, Quality, Regulatory Affairs, Finance, and senior leadership to structure commercially practical agreements that balance risk and support long-term customer relationships. Additional responsibilities include managing other commercial contracts such as confidentiality, vendor, consulting, collaboration, and corporate agreements.
This is a remote position for candidates located in the NJ, PA, or DE area.
Responsibilities
- Lead drafting, review, negotiation, and interpretation of complex commercial supply agreements for API and finished pharmaceutical products.
- Negotiate key commercial supply provisions including pricing, forecasting, minimum purchase commitments, capacity reservations, supply assurance, inventory, change management, quality obligations, regulatory compliance, intellectual property, indemnification, limitation of liability, supply disruptions, and technology transfer.
- Provide practical legal advice balancing commercial objectives, operational realities, regulatory requirements, and legal risk.
- Collaborate closely with Business Development, Operations, Technical Services, Quality, Regulatory Affairs, and Finance on customer negotiations and contract execution.
- Draft, review, and negotiate other agreements such as master services agreements, confidentiality agreements, vendor agreements, and other contracts as needed.
- Negotiate directly with customers and counterparties; manage outside counsel when required.
- Ensure contracts comply with regulatory requirements, company policies, and evolving industry standards.
- Track contract and project status and communicate regularly with stakeholders.
- Develop and maintain data-driven contract analytics.
- Assess emerging legal risks (e.g., AI use, data security, cross-border data transfers, evolving regulatory frameworks) and update templates and processes proactively.
- Partner cross-functionally on digital transformation initiatives including AI governance, data privacy compliance, and cybersecurity clauses.
Qualifications
Education / Experience
- Juris Doctor (JD) from an accredited law school.
- Admission to the bar and in good standing in at least one U.S. jurisdiction.
- Minimum of 10 years of progressive experience drafting, reviewing, and negotiating complex commercial agreements in the life sciences, pharmaceutical, biotech, or CDMO industry.
- Substantial experience as lead counsel for commercial supply agreements involving API and/or finished pharmaceutical products.
- Highly preferred experience advising CDMOs or life sciences companies on commercial manufacturing relationships, including GMP-regulated operations.
- Highly desirable experience negotiating sophisticated intellectual property provisions in pharmaceutical development and commercial supply agreements, including ownership allocation, background and foreground IP, technology transfer, and related licensing arrangements.
- Experience at a leading law firm and/or in-house legal department supporting life sciences clients.
- Exposure to or experience using AI-assisted drafting tools, automation platforms, or legal technology solutions in contracting workflows is a plus.
- Experience using data and metrics to improve contract cycle times.
- Preferred familiarity with cross-border contracting considerations, data privacy regulations, and evolving regulatory frameworks impacting global life sciences companies.
Knowledge / Skills / Abilities
- Demonstrated ability managing and negotiating contracts, preferably at a CDMO or a company in the pharmaceutical or biotech industry.
- Strong understanding of business and operational drivers of CDMO relationships, including forecasting, capacity planning, quality systems, regulatory compliance, technology transfer, validation, and supply continuity.
- Excellent legal writing, analytical reasoning, and verbal communication skills with the ability to distill complex legal issues into practical business guidance.
- Process-oriented mindset with the ability to identify inefficiencies and drive continuous improvement and scalability.
- Strong organizational and prioritization skills to manage multiple transactions under tight deadlines.
- Excellent attention to detail while maintaining commercial pragmatism.
- Ability to independently manage numerous sophisticated negotiations with minimal supervision.
- Ability to quickly learn and adapt to new information and conduct risk/benefit analysis; strong analytical skills and demonstrated business acumen.
- Proficiency in Microsoft Office Suite; experience with contract management tools such as Salesforce preferred.
- This position is ideally located in the Tri-State area (NJ, PA, DE).
Location
Remote hire within the New Jersey, Pennsylvania, or Delaware area.