Careers

SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded, clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our pipeline includes two clinical-stage compounds: SCY-770, a novel, highly selective direct AMPK activator in development for autosomal dominant polycystic kidney disease (ADPKD), and SCY-247, a second-generation triterpenoid antifungal candidate currently in Phase 1 development for the treatment and prevention of invasive fungal infections.

We are seeking an experienced Director, Drug Product Development, to be based in our Jersey City, NJ office. This role will lead drug product strategy and execution across our clinical-stage portfolio, supporting the advancement of innovative therapies for patients with serious rare diseases.

The Director, Drug Product Development will lead formulation, manufacturing, and lifecycle activities for drug product candidates from development through clinical-stage execution. This role partners across CMC, Quality, Regulatory, Supply Chain, and external manufacturers to ensure drug products are robust, scalable, and aligned with program timelines and regulatory requirements.

• Drug Product Development Strategy: Lead drug product development strategy across the clinical-stage portfolio, including formulation design, process development, manufacturability, and lifecycle planning.
• Formulation & Clinical Supply Execution: Develop and optimize scalable dosage forms and manufacturing processes to support clinical studies, technical transfers, and reliable product supply. Conduct drug product risk assessment and develop risk mitigation plans.
• External Manufacturing Leadership: Select, oversee, and manage CDMOs, CMOs, and other external partners to ensure timely execution, quality performance, and alignment with program objectives.
• CMC Regulatory Support: Contribute to CMC strategy and author, review, or support regulatory submissions and responses, amendments, briefing documents, and other health authority interactions as needed.
• Cross-Functional Program Leadership: Partner closely with Analytical Development, Drug Substance, Quality, Regulatory, Clinical Operations, and Supply Chain to align technical plans with development timelines, budgets, and program priorities.
• Technical Representation & Governance: Represent drug product development in internal governance forums and external meetings with manufacturers, auditors, consultants, and development partners, serving as a key technical leader for product-related decisions.

• Ph.D. in Pharmaceutical Sciences, Chemical Engineering, or related Physical Sciences with at least 12 years of experience, or M.S. with 15 years of experience working in drug product development in the pharmaceutical or biotechnology industry.
• In-depth knowledge and hands-on experience leading drug product development and CMC activities for small molecule programs in a clinical-stage biotechnology or pharmaceutical environment.
• Demonstrated success advancing programs through key development milestones, including clinical trial supply, process scale-up, technology transfer, and regulatory submissions.
• Strong working knowledge of CMC regulatory requirements and development expectations for IND-enabling and clinical-stage programs. Proven experience writing CMC drug product sections in regulatory submissions.
• Experience managing CDMOs, CMOs, and other external development and manufacturing partners, with the ability to drive accountability, timelines, and quality outcomes.
• Broad cross-functional CMC expertise, with the ability to work effectively across Drug Substance, Analytical, Quality, Regulatory, Supply Chain, and Clinical teams.
• Excellent written and verbal communication skills, including the ability to communicate complex technical issues clearly to internal and external stakeholders.
• Strong leadership, judgment, and problem-solving skills, with the ability to operate effectively in a fast-paced, resource-conscious, entrepreneurial environment.
• Proven ability to build productive relationships with external partners, consultants, and scientific advisors.
• Experience mentoring team members and contributing to a collaborative, high-accountability culture is preferred.

SCYNEXIS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.

The starting pay for this role is between $200,000.00 and $235,000.00. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors.

We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.

SCYNEXIS, Inc. (NASDAQ: SCYX) is a publicly traded, clinical-stage biotechnology company dedicated to advancing innovative solutions for severe rare diseases. Our pipeline includes two clinical-stage compounds: SCY-770, a novel highly selective direct AMPK activator in development for autosomal dominant polycystic kidney disease (ADPKD), and SCY-247, a second-generation triterpenoid antifungal candidate currently in Phase 1 development for the treatment and prevention of invasive fungal infections.

We are seeking an experienced Manager, Preclinical Operations to be based in our Jersey City, NJ office. Reporting to the Director, Program Management, this role will oversee the operational execution of outsourced preclinical development activities, ensuring studies are delivered efficiently, compliantly, and in alignment with program and regulatory objectives defined by cross-functional leaders.

The Manager, Preclinical Operations is responsible for the planning, coordination, execution, and oversight of outsourced preclinical studies that support SCYNEXIS’ development programs. This role manages the operational aspects of study delivery across pharmacology, toxicology, DMPK/ADME, and bioanalysis activities, ensuring studies are appropriately scoped, contracted, scheduled, tracked, and completed on time, within budget, and in accordance with quality, regulatory, and compliance requirements. The position serves as the primary operational interface between internal functional teams and external CROs, laboratories, consultants, and service providers, driving day-to-day execution, issue resolution, and study progress across multiple concurrent development activities.

This is an operations-focused role rather than a scientific research position and requires strong project management, vendor oversight, cross-functional coordination, budget management, and organizational skills.

• Develop and maintain integrated operational preclinical plans aligned with program milestones, regulatory timelines, and corporate objectives, in partnership with Program Management and cross-functional leads.
• Coordinate the initiation, execution, and closeout of outsourced preclinical studies across multiple workstreams and vendors.
• Manage study timelines, deliverables, dependencies, and risks to ensure on-time and high-quality execution.
• Serve as the primary operational liaison between internal functional teams and external CROs, laboratories, consultants, and service providers.
• Coordinate vendor selection activities, including RFP/RFQ processes, proposal evaluation, and contract scoping.
• Oversee CRO and vendor performance through governance meetings, action tracking, issue resolution, and performance monitoring.
• Partner with Procurement, Legal, and Finance to manage contracts, statements of work, change orders, and vendor relationships.
• Track program budgets, monitor expenditures, forecast spend, and identify cost-saving opportunities and budget risks.
• Coordinate study logistics, including sample shipments, test article management, and chain-of-custody documentation in partnership with CMC and Supply Chain teams.
• Maintain centralized study records, operational trackers, and documentation repositories that support audit and inspection readiness.
• Ensure deliverables, reports, and study documentation meet agreed quality standards and timelines.
• Support preparation of documentation and operational activities related to regulatory submissions, including IND-enabling programs.
• Facilitate cross-functional communication, governance meetings, decision tracking, and stakeholder reporting to ensure organizational alignment.
• Create and maintain project dashboards, status reports, key performance metrics, and risk management tools to support program and portfolio visibility.
• Drive continuous improvement of preclinical operational processes, including SOPs, templates, tools, and best practices that enhance efficiency, transparency, and scalability.

• Bachelor's degree in Life Sciences, Business, Operations, or a related field, with a minimum of 7 years of relevant experience in the biotechnology or pharmaceutical industry, including preclinical operations, development operations, program management, and/or CRO and vendor management.
• Demonstrated experience managing outsourced studies and coordinating activities across CROs, laboratories, consultants, and cross-functional teams to deliver program objectives on time and within budget.
• Strong project management expertise, including study planning, timeline management, budgeting, forecasting, risk mitigation, contract administration, and stakeholder communication.
• Experience supporting preclinical development programs, including toxicology, DMPK/ADME, bioanalysis, pharmacology, and other IND-enabling activities.
• Proven ability to build and manage productive vendor relationships while driving accountability, performance, and issue resolution.
• Strong organizational skills with the ability to manage multiple studies, priorities, timelines, and deliverables in a dynamic environment.
• Excellent written and verbal communication skills, including the ability to translate scientific objectives into clear operational plans, status updates, and executive communications.
• Experience supporting audit readiness, documentation management, regulatory submission activities, and compliance-related processes.
• Proficiency with Microsoft Office applications and project management tools such as Smartsheet, Microsoft Project, or similar platforms.
• Experience in a small to mid-sized biotechnology environment and project management certification (e.g., PMP, CAPM, or equivalent) are preferred.
• Occasional travel (e.g., 0–15%) for vendor meetings, audits (if applicable), or internal planning sessions.

SCYNEXIS is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or other characteristics protected by law.

The starting pay for this role is between $125,000.00 and $150,000.00. The estimated salary range represents an anticipated range for this position. The actual base salary offered may vary based on a variety of factors.

We offer a competitive total rewards package that includes short-term and long-term incentive programs and a comprehensive benefits package, including medical, dental, and vision coverage, a 401(k) with company match, paid time off, and additional benefits.