Job Description:The Vice President, Manufacturing and Technical Operations is responsible for leading the Company's external manufacturing and technical operations activities across the product lifecycle, from early-stage development through commercialization and post-approval support. Operating within a fully outsourced manufacturing model, this role provides strategic and technical oversight of the Company's CDMO network to ensure compliant, reliable, timely, and cost-effective product supply. The Vice President establishes manufacturing strategies, directs process development and technology transfer, oversees manufacturing execution and lifecycle management, and proactively manages technical and supply risks. The role serves as the primary senior-level interface with CDMOs and license partners and is accountable for partner performance, issue escalation, and delivery against Company objectives. Working cross-functionally with Supply Chain, Quality, Regulatory Affairs, Clinical Development, and other functions, the Vice President leads complex programs through execution and ensures manufacturing plans remain aligned with the Company's portfolio priorities, regulatory commitments, clinical needs, and commercial goals.
Summary of Key Responsibilities- Lead the manufacture and packaging of the Company's clinical and commercial products through external partners, ensuring compliant, reliable, and timely supply across applicable markets.
- Establish manufacturing plans, production schedules, capacity requirements, and supply-risk mitigation strategies in collaboration with Supply Chain, Quality, Regulatory Affairs, and other relevant functions.
- Provide on-site technical oversight at CDMOs during critical manufacturing, validation, technology-transfer, inspection-readiness, or troubleshooting activities, as required.
- Lead phase-appropriate process development, scale-up, technology transfer, qualification, and validation activities for manufacturing and packaging operations.
- Lead the technical evaluation, selection, qualification, and onboarding of new CDMOs, ensuring activities meet regulatory, quality, timeline, supply, and budget requirements.
- Drive lifecycle improvements that enhance process robustness, yield, capacity, reliability, and cost-effectiveness.
- Establish clear requirements, deliverables, timelines, governance, and escalation pathways with CDMOs and hold partners accountable for performance.
- Ensure manufacturing and packaging operations comply with cGMP, approved processes, regulatory filings, quality agreements, and Company requirements.
- Author and review manufacturing and technical content for regulatory submissions, agency responses, and pre- and post-approval changes in collaboration with Regulatory Affairs.
- Assess the technical and regulatory impact of proposed changes to processes, analytical methods, packaging, equipment, sites, or suppliers.
- Support regulatory inspections and pre-approval inspections by coordinating technical preparation, documentation readiness, and subject-matter-expert participation.
- Author, review, and approve technical documents within delegated authority, including protocols, reports, master batch records, risk assessments, investigations, change controls, and Technical Operations procedures.
- Partner with Quality Assurance to support CDMO qualification, audits, compliance oversight, and inspection readiness while maintaining appropriate independence of Quality decision-making.
- Conduct technical and CMC due diligence for potential acquisitions, licensing opportunities, partnerships, and new product opportunities, identifying key risks, costs, timelines, and resource requirements.
- Develop and manage Technical Operations budgets, forecasts, vendor commitments, and project expenditures, ensuring financial discipline and accurate invoicing.
- Establish performance metrics and communicate program status, risks, decisions, and resource needs to internal stakeholders and leadership.
- Maintain current knowledge of relevant scientific advances, industry practices, and regulatory expectations related to CMC, manufacturing, packaging, and analytical control.
Required Qualifications and Skills• Bachelor's degree in chemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, or a related scientific or engineering discipline; an advanced degree is preferred.
• At least 15 years of progressively responsible experience in CMC, pharmaceutical development, manufacturing, or Technical Operations, including experience leading programs in an outsourced manufacturing environment.
• Broad experience across multiple product modalities and manufacturing platforms. Experience with at least two of the following is strongly preferred: oral solid dosage forms, biologics, and oligonucleotide products.
• Strong understanding of drug substance and drug product development, process scale-up, technology transfer, process validation, commercial manufacturing, packaging, and lifecycle management.
• Demonstrated ability to apply technical knowledge across different modalities and quickly assess unfamiliar manufacturing processes, technologies, and product platforms.
• Strong knowledge of global CMC requirements and experience supporting regulatory submissions, agency interactions, inspections, and pre- and post-approval changes.
• Thorough understanding of cGMP requirements, pharmaceutical quality systems, and the technical assessment of deviations, investigations, change controls, CAPAs, and manufacturing risks.
• Demonstrated success managing CDMOs, including establishing expectations, overseeing execution, resolving complex technical issues, escalating risks, and holding external partners accountable for performance.
• Strong scientific judgment and a demonstrated ability to integrate complex technical information, identify root causes, evaluate risk, and make sound, timely decisions.
• Proven ability to lead multiple complex programs, establish priorities, manage competing demands, and deliver results in a dynamic, cross-functional environment.
• Excellent leadership, collaboration, negotiation, and communication skills, with the ability to influence internal and external stakeholders at all organizational levels.
• Strong written and verbal communication skills, including the ability to present complex technical matters clearly to executive leadership, regulatory authorities, partners, and nontechnical audiences.
Travel Requirements: 30% domestic and international
