Associate Director – Pharmaceutical Development
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Pharmaceutical development leader overseeing small-molecule formulation, scale-up, technology transfer, and CDMO operations. Supporting Celcuity’s targeted cancer therapies and global regulatory submissions.
Responsibilities:
- Manage drug formulation technology transfers, scale-up, and manufacturing processes
- Serve as the primary technical liaison between Celcuity and external CDMOs
- Direct late-stage drug product design, scale-up, and manufacturing robustness using QbD principles
- Oversee external vendors and laboratories for clinical, process validation, and commercial batch production
- Oversee production of drug product batches for clinical trial materials and commercial production
- Author and review CMC documents for global IND, IMPD, NDA, and MAA filings
- Partner with analytical development, supply chain, quality assurance, and clinical operations in a matrixed team
- Manage project timelines, program risks, and financial forecasting for outsourced operations
- Manage day-to-day operations and strategic alignment with global CDMO partners
- Lead technical transfers from internal discovery to external clinical facilities
- Identify alternative vendors and process bottlenecks to mitigate outsourced supply-chain risk
- Troubleshoot technical manufacturing issues, deviations, and OOS results at external sites
Requirements:
- Ph.D., Master's degree, or Bachelor's degree in Chemistry, Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, or closely related field
- Proven track record scaling manufacturing processes from pilot scale through cGMP environments to commercial production
- Strong negotiation, conflict-resolution, and remote cross-functional communication abilities
- 8+ years of experience in small molecule drug product development
- Understanding of physical pharmacy, crystallization, and material science
- Minimum 3 years directly managing small molecule CDMOs through scale-up and clinical supply campaigns
- Comprehensive understanding of ICH guidelines (Q1-Q11), cGMP requirements, and Quality by Design (QbD) principles
Benefits:
- Annual performance incentive bonus
- New hire equity package
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) match
- PTO
- Paid holidays
Similar Jobs
Director, Global Talent – Learning
Director building Chromalloy’s global talent, learning, internship, rotational, mentoring, and engagement programs. Supporting aerospace component repair and manufacturing through enterprise development infrastructure.
2D Technical Director
2D Technical Director building Toon Boom Harmony pipelines and automation tools for Glitch Productions. Owning technical infrastructure for its animation studio as the division scales.
Pricing Director
Pricing Director transforming monetization for Ping Identity’s enterprise cloud identity platform. Designing packaging, AI and usage-based pricing, financial models, and cross-functional rollout strategies.
Service Director – Application Managed Services
Service Director leading EHR application support, ITSM quality, reporting, and continuous improvement for healthcare consulting firm. Managing client delivery, teams, vendors, and service expansion.
Compensation Analytics & Intelligence Director
Compensation Analytics & Intelligence Director leading data, AI, and technology-enabled rewards strategy at Danaher, a global life sciences and diagnostics innovator. Advising leaders on complex compensation decisions.
Associate Director, Regional Access Specialist
Regional Access Specialist supporting reimbursement and patient access for Mirum Pharmaceuticals’ rare-disease therapies. Educating HCPs and coordinating payer, MAP, sales, medical, and marketing access efforts.
Director
Shopify Platform & Web Lead owning architecture, development, SEO, analytics, and integrations for Valerie’s multi-brand ecommerce platforms in India. Leading engineers and AI-assisted digital optimization.
Director, Philanthropy
Director of Philanthropy driving major-gift fundraising for Food Banks Canada’s national food-bank network. Building donor pipelines, leading the Major Gifts team, and generating $2–$3M annually.
Application Support Director – Managed Services
Director leading application support, platform operations, and managed services for ReSource Pro, an insurance workflow and technology services provider. Improving SLA performance, incident response, automation, and client outcomes across global delivery teams.
Director – Electric Utilities
Director managing utility interconnection, transmission strategy, and stakeholder relationships for STACK’s data center infrastructure projects. Supporting site diligence, utility planning, budgets, and development business cases.
Director, Asset Management
Director managing utility-scale battery storage assets for Energy Vault, a global energy storage and power infrastructure company. Overseeing compliance, commercial optimization, maintenance, and operational performance across asset lifecycles.
Associate Director, PMO
Associate Director managing strategic healthcare marketing programs at EVERSANA INTOUCH. Leading PMO teams, client delivery, staffing, financial reporting, risk, and program health.
Director, Standards Strategy and Engagement
Experian director shaping digital identity, trust, security, and AI commerce standards. Advising leaders and influencing industry ecosystems for a global data and technology company.
Product Director – Professional Services
Product Director owning ERP product vision and roadmap for professional services organizations at Unit4. Driving AI-enabled workflows, platform alignment, customer outcomes, and commercial growth.
Product Director – Higher Education, School Boards
Product Director owning Unit4 ERP strategy for higher education and K-12 institutions. Translating sector, finance, compliance, and AI needs into scalable products.
Product Director – Public Sector
Product Director owning Unit4’s public-sector ERP vision, roadmap, and solutions. Connecting finance, HR, procurement, and operations for government organizations in Spain.
Product Director – Public Sector
Product Director leading public sector software strategy at Unit4. Owning product vision, managing backlog, and ensuring alignment with platform strategy.
Product Director – Professional Services
Product Director at Unit4 managing ERP solutions for Professional Services organizations. Driving product vision and strategy with a focus on AI and industry-specific needs.
Senior Director, Supplemental Providers – Enhanced Benefits
Senior Director overseeing Medicaid supplemental benefits and vendor strategy for CareSource health plans. Leading compliant vendor operations, benefit optimization, governance, and enterprise teams.
Executive Director
Executive Director scaling Munchausen Support Foundation, a nonprofit providing survivor support, research, and education. Leading programs, fundraising, finances, volunteers, and remote operations.