Executive Director, Process Development & CMC Lead

BioCT Innovation Commons; Danbury (CT); Hybrid; USD 180,000 - 240,000; Full time

Job summary

MannKind Corporation seeks a Process Development & CMC Lead to steer process development, scale-up, tech transfer, and regulatory CMC activities across development programs in a fast-paced setting. The role includes ownership of Phase 2/3 strategies, PPQ planning, and readiness for commercial launch of inhaled or advanced drug products.

The ideal candidate has extensive late-phase experience, cross-functional leadership, and strong communication with senior leadership to guide regulatory

Qualifications

• PhD in chemical engineering or related field with 18+ years of pharmaceutical development, or MS/BS with 20+ years of relevant experience.
• Extensive people-management experience leading scientists, engineers, managers, or cross-functional teams.
• Proven experience leading Process Development, Manufacturing Science and Technology, Technical Operations, or CMC functions for complex products.
• Proven experience as CMC Lead, program technical lead, or equivalent cross-functional development leader.
• Direct late-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ planning, and launch readiness.
• Strong understanding of drug product, drug substance, analytical, formulation, process development, manufacturing, and regulatory CMC interdependencies.
• Experience with technology transfer to internal sites and/or CDMOs.
• Experience authoring, reviewing, or defending CMC sections of regulatory filings and dealing with health authority questions or inspections.
• Strong communication, collaboration, and stakeholder-management skills for senior leadership.
• Ability to operate in a fast-paced, resource-constrained development environment with shifting priorities.

Responsibilities

• Lead Process Development Activities: strategic and technical leadership for process development, scale-up, characterization, technology transfer, and manufacturing-readiness.
• Lead CMC Teams: chair cross-functional teams, drive integrated plans, and align processes across multiple functions.
• Develop phase-appropriate CMC strategies for Phase 2/3, registration, validation, PPQ, and commercial launch readiness.
• Regulatory Leadership: contribute to Module 3/IND/NDA/MAA CMC sections and interact with health authorities.
• Technology Transfer and Manufacturing Readiness: manage technology transfer and establish robust control strategies.
• Quality & GMP Partnership: ensure GMP adherence, data integrity, and inspection readiness.
• Resource and Portfolio Management: align capabilities with program needs and corporate priorities.
• Team Leadership: build and coach a high-performing Process Development team.
• Risk Management: identify and mitigate technical and program risks with clear options and escalation.

Skills

People management

Leadership

CMC leadership

Late-phase development

Regulatory knowledge

Communication

Cross-functional collaboration

Quality & GMP

Risk management

Technical translation to leadership

Education

PhD in Chemical Engineering or related field (18+ years)

Job description

MannKind Corporation is a biopharmaceutical company dedicated to transforming chronic disease care through innovative, patient‑centric solutions, developing and commercializing innovative inhaled therapeutics and drug‑device technologies aimed at addressing serious unmet needs across endocrine, cardiorenal, and orphan lung diseases. The company applies deep expertise in formulation science and inhalation‑device engineering to reduce the treatment burden for conditions such as diabetes, congestive heart failure, pulmonary fibrosis, and pulmonary hypertension. MannKind’s core technologies, including ultrafine dry‑powder formulations and advanced inhalation platforms, enable rapid, convenient delivery of medicines directly to the deep lung. This approach supports both local pulmonary targeting and systemic delivery for various medical indications. Through alternative drug formulations and delivery mechanisms, MannKind aims to bring forward differentiated, patient‑centric therapies that expand treatment options to improve outcomes across chronic and rare diseases.

At MannKind, our employees are our greatest asset. We foster a close-knit, collaborative culture where every team member plays a vital role in our mission. We are proud to champion a rich blend of backgrounds, perspectives, and working styles as we work together to improve health outcomes and change lives.

Job Summary:

The Process Development & CMC Lead will provide strategic and technical leadership for the Process Development group while also serving as the CMC Lead for one or more development programs. This role is responsible for process development, scale-up, technology transfer, manufacturing readiness, and integrated CMC execution across MannKind's pipeline. The ideal candidate will have significant late-phase development experience, including Phase 3 execution, regulatory submissions, process validation, PPQ strategy, and commercial launch readiness for complex, inhaled, or particle‑engineered products.

This position is located in Danbury, Ct and requires onsite presence Monday-Thursday, Fridays are remote.

Key Responsibilities:

• Lead Process Development Activities: Provide strategic and technical leadership for process development, scale-up, process characterization, technology transfer, and manufacturing-readiness activities across pipeline and lifecycle programs.
• Lead CMC Teams: Serve as CMC Lead for one or more development programs, chair cross‑functional CMC teams, drive integrated plans, and align Process Development, Formulation, Analytical, Quality, Regulatory, Clinical Manufacturing, Supply Chain, and external partners.
• Late‑Phase Development Strategy: Develop and execute phase‑appropriate CMC strategies for Phase 2, Phase 3, registration, process validation, PPQ, and commercial launch readiness.
• Regulatory Leadership: Own or contribute to relevant Module 3 / IND / NDA / MAA CMC sections, support health authority interactions, and ensure CMC strategies are aligned with FDA, EMA, and other regulatory expectations.
• Technology Transfer and Manufacturing Readiness: Lead technology transfer activities, establish manufacturing control strategies, and ensure scalable, robust, and compliant processes.
• Quality and GMP Partnership: Partner effectively with Quality to ensure phase‑appropriate GMP discipline, data integrity, investigation support, SOP alignment, and inspection readiness without creating unnecessary development burden. Proactively identify, assess, and mitigate quality and compliance risks while maintaining development agility and efficient program execution.
• Resource and Portfolio Management: Establish departmental priorities, manage resources and budgets, and ensure Process Development capabilities are aligned with CMC program needs and corporate priorities. Partner with senior leadership to evaluate portfolio opportunities, assess CMC investment requirements, and provide strategic recommendations that support corporate objectives and program success.
• Team Leadership: Build, lead, coach, and develop a high‑performing Process Development team with clear accountability, strong cross‑functional collaboration, and consistent execution against commitments.
• Risk Management and Escalation: Identify and manage technical, operational and program‑level CMC risks, drive mitigation plans, make clear recommendations, and elevate issues early with options, trade‑offs, and decision points.

Qualifications:

• PhD in Chemical Engineering, Pharmaceutical Sciences, Chemistry, Biomedical Engineering, Mechanical Engineering, or a related field with 18+ years of relevant experience; or MS/BS with 20+ years of relevant pharmaceutical development experience.
• Significant people‑management experience leading scientists, engineers, managers, or cross‑functional technical teams.
• Demonstrated experience leading Process Development, Manufacturing Science and Technology, Technical Operations, or CMC functions for complex pharmaceutical products.
• Proven experience serving as a CMC Lead, program technical lead, or equivalent cross‑functional development leader.
• Direct late‑phase development experience, ideally including Phase 3 execution, NDA/MAA preparation, process validation, PPQ planning, and commercial launch readiness.
• Strong understanding of drug product, drug substance, analytical, formulation, process development, manufacturing, and regulatory CMC interdependencies.
• Experience with technology transfer to internal manufacturing sites and/or CDMOs.
• Experience authoring, reviewing, or defending CMC sections of regulatory filings and supporting health authority questions or inspections.
• Strong communication, collaboration, and stakeholder‑management skills, including the ability to communicate complex technical issues clearly to senior leadership.
• Ability to operate effectively in a fast‑paced, resource‑constrained development environment with shifting priorities.

Preferred Skills:

• Experience with inhaled drug products, dry powder inhalers, particle‑engineered products, complex dosage forms, or drug‑device combination products.
• Experience taking at least one product through late‑stage development, regulatory submission, validation, approval, or commercial launch.
• Familiarity with QbD, control strategy development, process characterization, continued process verification, and lifecycle management.
• Experience working with FDA, EMA, notified bodies, or other regulatory agencies on CMC, combination product, or manufacturing‑readiness topics.
• Experience building or improving development‑stage CMC infrastructure, operating models, decision frameworks, SOPs, templates, or governance practices.
• Experience leading teams through technical disagreement, quality interface issues, and cross‑functional decision‑making with a clear, collaborative, and accountable style.