Engineer III, Packaging (9-12 Month Contract) at Mannkind

Burlington, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

12 Aug, 26

Salary

60.6

Posted On

15 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Package Engineering, Pharmaceutical Packaging, cGMP, Materials Test Methodology, Regulatory Compliance, NDA Submission, Technical Writing, Project Management, Scale-up, Scientific Analysis, Packaging Specifications, Laboratory Procedures

Industry

Pharmaceutical Manufacturing

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: Responsible for Package Technology projects necessary to design, develop and transfer cost effective and sound packaging for pharmaceutical products. Determines packaging specifications according to the nature of the product, cost limitations, legal requirements, and the type of protection required, considering need for resistance to such external variables as moisture, corrosive chemicals, temperature variations, light, heat, handling and tampering. Essential Duties: Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Interacts in a team environment as part of the development, transfer and launch project structures, as well as required to work independently on the technical and regulatory tasks necessary to support corporate and team goals. · Design drug product packaging in support of the drug development process by identifying: o Critical drug product attributes as defined by Development teams o Commercialization requirements set by Marketing o Regulatory needs supporting NDA submission, review and approval o 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

Responsibilities

Responsible for designing, developing, and transferring cost-effective packaging for pharmaceutical products while ensuring regulatory compliance. This includes creating purchasing specifications and managing the scale-up of packaging technologies to production.