Sr. Engineer, Packaging (9-12 Month Contract)

MannKind Corporation; Burlington (MA); On-site; USD 110,000 - 150,000; Full time

Job summary

MannKind Corporation in Massachusetts is seeking a Packaging Engineer to design drug product packaging across development stages, identifying critical attributes and regulatory needs to support NDA submissions. You will develop packaging technologies, perform data-driven analyses, and prepare specifications to facilitate production readiness while ensuring compliance with cGMPs and safety guidelines.

The role requires collaboration with Development, Regulatory, and Quality teams, and offers

Qualifications

• BS Degree in Package Engineering with 7-10 years experience in pharma packaging (or MSc with 5-7 years).
• Knowledge of cGMPs and regulatory aspects affecting pharmaceutical packaging development.
• Working knowledge of materials test methodology, laboratory procedures and packaging equipment.
• Strong organizational skills and ability to manage multiple responsibilities.

Responsibilities

• Design drug product packaging supporting development by identifying critical attributes and regulatory needs for NDA submission, and production considerations.
• Develop packaging technologies using engineering principles and data synthesis to evaluate package performance.
• Support clinical supply by designing appropriate drug product packaging.
• Scale up packaging technologies to production with technical and financial plans.
• Write purchasing specifications for packaging components, equipment and processes.
• Coordinate and participate in packaging launch activities for new product introductions.
• Generate development and investigation reports for package components, materials and processes.
• Observe all Health, Safety and Environmental guidelines.
• Duties may include other assignments as necessary.

Skills

Materials test methodology

Laboratory procedures

Packaging equipment knowledge

Organizational skills

Education

BS Degree in Package Engineering

MS degree in related field

Job description

MannKind is committed to developing and commercializing innovative therapeutic products for patients living with endocrine and orphan lung diseases. We are on a mission to give people control of their health and the freedom to live life.

At MannKind, our employees are our number one asset, and we foster a tight-knit community where each of us plays a critical role in our collective success. We strive to provide a work environment where diversity of background, thought and perspective is valued and respected. Our team is also energized by the company’s entrepreneurial spirit that provides an environment in which you can evolve ideas quickly and nimbly.

Our Values serve as the foundation of MannKind’s culture. They define who we are, how we act, and guide our interactions every day—both with each other and the customers we serve. At MannKind, you will work with people who are experts in their fields, see challenges as opportunities, are tenacious and push boundaries, bring creative and solutions-based thinking forward, and always believe in winning together.

Job Summary:

• Design drug product packaging in support of the drug development process by identifying:
  • Critical drug product attributes as defined by Development teams
  • Commercialization requirements set by Marketing
  • Regulatory needs supporting NDA submission, review and approval
  • Production efficiencies and standards as necessary
• Develop packaging technologies using engineering principles and scientific analysis to collect and synthesize data relating to package and drug product performance.
• Support clinical supply activities by designing appropriate drug product packaging.
• Scale up packaging technologies to production by compiling and executing the necessary technical and financial plans.
• Write, create and establish purchasing specifications for packaging requirements (components, in process controls) based upon development and transfer activities.
• Coordinate and participate in the launch activities related to packaging which are required to support new product introductions.
• Generate written development and investigation reports in support of package components, materials, equipment and processes.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.
• Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.

Minimum Qualifications

• BS Degree in Package Engineering with 7-10 years or MS with 5-7 years of related experience in package engineering in pharmaceuticals or the equivalent combination of training and experience.
• Working knowledge of materials test methodology, laboratory procedures and packaging equipment.
• Strong organizational skills and ability to manage multiple responsibilities.
• Knowledge of cGMP's and various regulatory aspects affecting pharmaceutical packaging development.