Executive Director, CMC
Executive Director, CMC
Posted on :
12-05-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
12-05-2025
Job Description
MannKind Corporationfocuses on the development and commercialization of innovative inhaled therapeutic products and devices to address serious unmet medical needs for those living with endocrine and orphan lung diseases. We are committed to using our formulation capabilities and device engineering prowess to lessen the burden of diseases such as diabetes nontuberculous mycobacterial (NTM) lung disease pulmonary fibrosis and pulmonary signature technologies drypowder formulations and inhalation devices offer rapid and convenient delivery of medicines to the deep lung where they can exert an effect locally or enter the systemic circulation depending on the target indication.
Job Summary:
The CMC Lead will play a pivotal role in overseeing Chemistry Manufacturing and Controls (CMC) activities for a Phase 3 program focused on inhaled dosage forms while also holding functional ownership of CMC leadership across the company. This role involves developing phaseappropriate CMC strategies standardizing practices and implementing tools to create a robust CMC infrastructure to support a growing pipeline.
Key Responsibilities:
- Lead CMC Activities:Oversee all CMCrelated activities for the Phase 3 program specifically focusing on inhaled dosage forms including drug substance drug product analytical methods and formulation development.
- Strategy Development:Develop and execute comprehensive CMC strategies for inhaled dosage forms to support the companys pipeline and ensure alignment with regulatory requirements.
- Standardization:Establish and standardize CMC practices across the organization to ensure consistency compliance and efficiency.
- Infrastructure Implementation:Implement tools and systems to build a robust CMC infrastructure that supports the companys growth and enhances operational capabilities.
- Crossfunctional Collaboration:Collaborate with Research Clinical Regulatory and Technical Operations teams to ensure seamless integration of CMC activities with overall program goals.
- Regulatory Compliance:Ensure all CMC activities comply with FDA EMA and other regulatory requirements including authoring CMC sections for regulatory filings specific to inhaled dosage forms.
- Quality Assurance:Develop and maintain SOPs GMP compliance and QC/QA standards to ensure highquality outputs.
- Resource Management:Allocate resources and manage budgets to ensure successful delivery of CMC milestones.
- Team Leadership:Build and lead a highperforming CMC team providing guidance coaching and support to team members.
Qualifications:
- Masters degree in chemistry Biochemistry Biotechnology or a related field; Doctoral degree preferred.
- 15 years of relevant experience in the pharmaceutical/biotech industry with a focus on inhaled dosage forms.
- Extensive knowledge of CMC processes including process chemistry drug substance drug product analytical methods and formulation for inhaled products.
- Proven experience in developing and implementing CMC strategies and infrastructure.
- Strong leadership and stakeholder management skills.
- Experience with regulatory filings and compliance in the US and EU.
- Excellent communication and collaboration skills.
Preferred Skills:
- Experience with advanced therapy medicinal products (ATMPs) and cell & gene therapies.
- Familiarity with Quality by Design (QbD) principles and advanced analytical techniques.
- Ability to work in a dynamic fastpaced environment and manage multiple priorities.
Required Experience:
Director
Employment Type
Full Time
Key Skills
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