Associate Director – Pharmaceutical Development

Celcuity

Pharmaceutical development leader overseeing small-molecule formulation, scale-up, technology transfer, and CDMO operations. Supporting Celcuity’s targeted cancer therapies and global regulatory submissions.

Posted 8/12/2026full-timeRemote • Minnesota • 🇺🇸 United StatesSenior💰 $180,000 - $210,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing drug formulation technology transfers and scale-up processes, with a strong focus on Quality by Design (QbD) principles and compliance with cGMP requirements. Proven ability to lead cross-functional teams and manage relationships with external CDMOs for successful drug product development.

Highest-signal resume keywords

Drug Formulation Technology TransferQuality By Design (QbD)CGMP ComplianceSmall Molecule Drug Product DevelopmentICH Guidelines (Q1-Q11)

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Drug Product DesignManufacturing Process Scale-UpCMC Document AuthoringProcess ValidationClinical Trial Material ProductionNegotiation SkillsConflict ResolutionTechnical TroubleshootingFinancial ForecastingMaterial Science

Soft Skills

Remote Cross-Functional CommunicationTeam Leadership

Industry Keywords

Pharmaceutical SciencesChemical EngineeringCGMP EnvironmentsClinical Supply CampaignsVendor Management

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

Annual performance incentive bonus
New hire equity package
Medical insurance
Dental insurance
Vision insurance
401(k) match
PTO
Paid holidays