Associate Director – Drug Product Development

Latigo Creative

. Lead drug product development strategy and execution for assigned small-molecule programs from candidate selection through clinical development, registration, and commercialization .

Posted 10/30/2026full-timeSan Francisco • California • United StatesSenior💰 $200,000 - $245,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in drug product development strategy and execution, particularly for small-molecule programs, with a strong focus on formulation and process optimization, regulatory submissions, and cross-functional collaboration. Proven ability to lead technical teams and manage CDMO/CMO activities while ensuring compliance with quality standards and regulatory requirements.

Highest-signal resume keywords

Drug Product Development StrategyFormulation And Process OptimizationRegulatory Submissions (Module 3.2.P)CDMO/CMO ManagementQuality By Design

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Formulation SelectionProcess Scale-UpProcess CharacterizationTechnology TransferPPQ/Process ValidationStability ProgramsControl Strategy DevelopmentOral Solid Dosage FormsParenteral FormulationsAmorphous Formulation Technologies

Soft Skills

Excellent Written CommunicationExcellent Verbal CommunicationInfluencing Across FunctionsProblem SolvingScientific Judgment

Tools & Technologies

CGMP RequirementsQuality Management SystemsRegulatory Compliance ToolsKnowledge Management SystemsEmerging Technologies

Industry Keywords

Pharmaceutical SciencesBiotechnologyCross-Functional TeamsRisk ManagementGlobal/ICH Quality Guidance

About the role

Key responsibilities & impact

Lead drug product development strategy and execution for assigned small-molecule programs from candidate selection through clinical development, registration, and commercialization
Serve as the drug product CMC lead on cross-functional program teams
Communicate technical options, risks, dependencies, timelines, and recommendations to CMC and program leadership
Plan and oversee formulation and process development, including formulation selection and optimization, process scale-up, process characterization, pivotal and registration batch planning, and registration stability activities
Lead or support technology transfer to CDMOs/CMOs, engineering and registration campaigns, PPQ, CPV, and commercial launch preparation
Develop science- and risk-based product and process control strategies
Provide technical leadership for oral solid dosage forms and support parenteral dosage forms when applicable
Oversee manufacturing, packaging, container-closure systems, stability programs, investigations, deviations, change controls, and technical risk mitigation
Author and critically review drug product sections of global CMC submissions, including INDs, IMPDs, NDAs, MAAs, Module 3.2.P content, briefing documents, responses to information requests, and post-approval submissions
Prepare for and support interactions with FDA, EMA, MHRA, and PMDA and contribute to inspection and pre-approval inspection readiness
Partner with Drug Substance, Analytical Development, Quality, Regulatory Affairs, Clinical, Clinical Supply, Commercial Manufacturing, Supply Chain, Project Management, and Finance
Select and manage CDMOs/CMOs and other external partners, including technical scope, deliverables, timelines, budgets, quality interfaces, governance, and escalation
Provide technical guidance and mentorship to scientists and team members; at Director level, may lead personnel, broader initiatives, and resource planning
Contribute to functional standards, technical review practices, development best practices, knowledge management, emerging technologies, and regulatory expectations

Requirements

What you’ll need

D. or MS in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or a related discipline
At least 10-15 years of relevant pharmaceutical or biotechnology industry experience
Demonstrated ability to lead drug product activities for one or more development programs and work effectively on cross-functional CMC or program teams
Strong hands-on and technical oversight experience in formulation and process optimization, scale-up, technology transfer, process characterization, PPQ/process validation, stability, control strategy development, and manufacturing support
Experience authoring or critically reviewing drug product sections of regulatory submissions, particularly Module 3.2.P, and supporting responses to health-authority questions
Strong expertise in oral solid dosage forms
Experience with parenteral formulations, sterile product development, or associated manufacturing controls preferred
Experience with amorphous or other enabling formulation technologies for low-solubility compounds, such as solid dispersions, spray drying, hot-melt extrusion, or comparable approaches
Strong working knowledge of Quality by Design, pharmaceutical development risk management, cGMP requirements, and relevant global/ICH quality guidance
Demonstrated success managing CDMO/CMO activities, technical deliverables, budgets, schedules, and cross-functional interfaces in a fast-paced development environment
Ability to independently solve complex technical problems, exercise sound scientific judgment, and translate technical information into clear program recommendations
Excellent written and verbal communication skills and ability to influence across functions and organizational levels
Willingness to travel approximately 20% of the time, including domestic and international travel to partner sites, manufacturing facilities, and regulatory meetings