MannKind Corporation focuses 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 hypertension. Our signature technologies - dry-powder 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 phase-appropriate 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 CMC-related 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 company's 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 company's growth and enhances operational capabilities.
- Cross-functional 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 high-quality outputs.
- Resource Management: Allocate resources and manage budgets to ensure successful delivery of CMC milestones.
- Team Leadership: Build and lead a high-performing CMC team, providing guidance, coaching, and support to team members.
Qualifications:
- Master's 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, fast-paced environment and manage multiple priorities.
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Mannkind Corporation
May 09, 2025 