Development Packaging Engineer
Development Packaging Engineer Job Description
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com .
General
Job Description:
This position will support development of drug product packaging and packaging processes. The engineer will actively participate on cross functional teams through all phases of development.
Key Area of
Responsibilities:
Key areas of responsibility include:
Subject Matter Expert (SME) for various packaging processes including but not limited to bottle filling, blister card packaging, vial & ampoule labeling, kit assembly and pouching operations
Small scale packaging for development studies (blistering, bottling, vialing)
Prototyping of packaging and labeling including die cutting, printing and finishing
Draft packaging requirements and packaging component specifications
Evaluate materials, design, and configuration of primary, secondary, and other packaging to meet packaging requirements
Gather information from CMOs, supply chain and internal manufacturing groups to document evolution of packaging from development through commercial
Summarize and present data in a clear organized format that meet cross functional leader needs
Write and execute protocols and reports
Support writing of manufacturing and packaging sections of New Drug Applications (NDA)
Essential Requirements
5
years' experience in a regulated industry
2
years' experience with bottle filling or blistering operations
Experience working with die lines, die cutting processes and printing processess
Ability to use measurement devices and mechanical testing devices
Experience in a fast paced development environment
Proven ability to work independently given high-level direction
Proficiency with Microsoft Office products (Excel, Word, Powerpoint)
Ability to perform statistical calculations and design DOEs
Familiarity with JMP or other statistical software
Excellent oral and written communication skills
Experience executing risk assessments
Solid Works / CAD skills a plus
Experience with design controls a plus
Educational Requirements:
BS or BE in a relevant engineering discipline (i.e. material science, mechanical engineer, packaging engineer)
Master's degree preferred
Travel Requirements:
Position requires a moderate amount of travel
#LI-DS1
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com .
General
Job Description:
This position will support development of drug product packaging and packaging processes. The engineer will actively participate on cross functional teams through all phases of development.
Key Area of
Responsibilities:
Key areas of responsibility include:
Subject Matter Expert (SME) for various packaging processes including but not limited to bottle filling, blister card packaging, vial & ampoule labeling, kit assembly and pouching operations
Small scale packaging for development studies (blistering, bottling, vialing)
Prototyping of packaging and labeling including die cutting, printing and finishing
Draft packaging requirements and packaging component specifications
Evaluate materials, design, and configuration of primary, secondary, and other packaging to meet packaging requirements
Gather information from CMOs, supply chain and internal manufacturing groups to document evolution of packaging from development through commercial
Summarize and present data in a clear organized format that meet cross functional leader needs
Write and execute protocols and reports
Support writing of manufacturing and packaging sections of New Drug Applications (NDA)
Essential Requirements
5
years' experience in a regulated industry
2
years' experience with bottle filling or blistering operations
Experience working with die lines, die cutting processes and printing processess
Ability to use measurement devices and mechanical testing devices
Experience in a fast paced development environment
Proven ability to work independently given high-level direction
Proficiency with Microsoft Office products (Excel, Word, Powerpoint)
Ability to perform statistical calculations and design DOEs
Familiarity with JMP or other statistical software
Excellent oral and written communication skills
Experience executing risk assessments
Solid Works / CAD skills a plus
Experience with design controls a plus
Educational Requirements:
BS or BE in a relevant engineering discipline (i.e. material science, mechanical engineer, packaging engineer)
Master's degree preferred
Travel Requirements:
Position requires a moderate amount of travel
#LI-DS1
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.
. Apply now!Estimated Salary: $20 to $28 per hour based on qualifications.
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