Engineer II

4 weeks ago

Lansdale, United States MassGenics Full time

Job Description: Position Description: • The successful candidate will focus on package development for delivery of traditional pharmaceuticals (oral solid dosage & sterile products) as well as provide input to primary and secondary packaging definition, and package systems qualifications. • In addition, the candidate will support the creation of registration samples for new products in collaboration with artwork and labeling teams as part of Filing and Launch Readiness activities. Packaging Responsibilities: • Providing input regarding selection of primary packaging material. • Determination of package images to support commercialization as well as leading the execution of distribution qualification efforts regarding testing robustness of packages. • The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of NDA’s, WMA’s, and JNDA’s. • The successful candidate will also interface with packaging component suppliers, our Global Packaging Technology Operations, our Packaging Site Operations, as well as Contract Manufacturing Operations while fulfilling their responsibilities.

Responsibilities: Position Description: • The successful candidate will focus on package development for delivery of traditional pharmaceuticals (oral solid dosage & sterile products) as well as provide input to primary and secondary packaging definition, and package systems qualifications. • In addition, the candidate will support the creation of registration samples for new products in collaboration with artwork and labeling teams as part of Filing and Launch Readiness activities. Packaging Responsibilities: • Providing input regarding selection of primary packaging material. • Determination of package images to support commercialization as well as leading the execution of distribution qualification efforts regarding testing robustness of packages. • The successful candidate will author packaging specifications for primary, secondary and tertiary packaging as well as provide information to support relevant sections of NDA’s, WMA’s, and JNDA’s. • The successful candidate will also interface with packaging component suppliers, our Global Packaging Technology Operations, our Packaging Site Operations, as well as Contract Manufacturing Operations while fulfilling their responsibilities.

Qualifications: Education Minimum Requirement: • The successful candidate will have a completed a B.S. or higher degree in Biomedical Engineering, Chemical Engineering, Materials Science, Packaging Engineering, Packaging Science, or Pharmaceutical Science with a minimum of 2 years of relevant experience. Author protocols, execute on studies, strong technical writing skills. Looking for Package development experience as main skillset Required Experience and Skills: • Understanding of package development process and engineering principles. • Demonstrated experience in building collaborative partnerships • Excellent verbal and written communication skills • Excellent project management skills • Ability to make disciplined rapid decisions

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