Director, Combination Product Development at Kiniksa Pharmaceuticals
Lexington, MA 02420
About the Job
Reporting to the Executive Director, Drug Product Development and Manufacturing, the Director, Combination Product Development will lead combination product design, development, and validation through strategic planning and oversight of design control, development, and manufacturing.This role is based in our Lexington, MA office
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Job Responsibilities (including, but not limited to):Establish strategies for and lead device design control and risk management for combination products with collaboration and input from cross-functional teamsLead platform device evaluation, selection, packaging design, and developmentIdentify and maintain user needs with input from cross-functional teamsDevelop, manage, and support execution of human factors studiesLead planning and support execution of design verification and design validation studiesConduct user related risk assessments and perform ethnographic analysisEstablish risk management strategies and associated documentation such as Hazard Analysis, Fault Tree, and FMEAsDevelop, author, review, and approve design control documentsConduct impact assessments for change control, including design history file and risk management framework assessmentsAuthor related sections in regulatory filing submissions (such as IND, IMD, BLA, MAA) and support responses to regulatory authority information requestsManage oversight of external partners and CDMOs for combination product design, development, testing, and manufacturingSupport manufacturing investigations in collaboration with Quality, external partners, and subject matter expertsSummarize and communicate project updates to stakeholdersStay current with the regulatory guidance, industry trends, and new emerging technologies as it relates to drug product development and manufacturingQualifications:8-10+ year industry experience in device and combination product developmentBS/MS/Ph.D
in mechanical or biomedical engineering (or other relevant discipline)Demonstrated knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc
with a focus on design controls and risk analysisExperience in biologics combination products such as autoinjectors, accessorized pre-filled syringes, and/or co-packed kitsExperience in technical oversight and collaboration with external partners and CDMOsExperience in device and combination product analytical test methodsEffectively and concisely communicate scientific rationale and data to project teamsDemonstrated strong technical writing and data analysis skillsExperience with aseptic fill/finish operations for pre-filled syringes is preferredExperience with inhalation delivery systems is a plusAbility to manage multiple priorities and work with ambiguity to deliver resultsAbility to travel up to 5%Salary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
Our office-based employees follow a hybrid schedule of 4 days in the office, and 1 day remote.Job Responsibilities (including, but not limited to):Establish strategies for and lead device design control and risk management for combination products with collaboration and input from cross-functional teamsLead platform device evaluation, selection, packaging design, and developmentIdentify and maintain user needs with input from cross-functional teamsDevelop, manage, and support execution of human factors studiesLead planning and support execution of design verification and design validation studiesConduct user related risk assessments and perform ethnographic analysisEstablish risk management strategies and associated documentation such as Hazard Analysis, Fault Tree, and FMEAsDevelop, author, review, and approve design control documentsConduct impact assessments for change control, including design history file and risk management framework assessmentsAuthor related sections in regulatory filing submissions (such as IND, IMD, BLA, MAA) and support responses to regulatory authority information requestsManage oversight of external partners and CDMOs for combination product design, development, testing, and manufacturingSupport manufacturing investigations in collaboration with Quality, external partners, and subject matter expertsSummarize and communicate project updates to stakeholdersStay current with the regulatory guidance, industry trends, and new emerging technologies as it relates to drug product development and manufacturingQualifications:8-10+ year industry experience in device and combination product developmentBS/MS/Ph.D
in mechanical or biomedical engineering (or other relevant discipline)Demonstrated knowledge of applicable regulations/standards, such as 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC 62366, Part 4, etc
with a focus on design controls and risk analysisExperience in biologics combination products such as autoinjectors, accessorized pre-filled syringes, and/or co-packed kitsExperience in technical oversight and collaboration with external partners and CDMOsExperience in device and combination product analytical test methodsEffectively and concisely communicate scientific rationale and data to project teamsDemonstrated strong technical writing and data analysis skillsExperience with aseptic fill/finish operations for pre-filled syringes is preferredExperience with inhalation delivery systems is a plusAbility to manage multiple priorities and work with ambiguity to deliver resultsAbility to travel up to 5%Salary is commensurate with experienceKiniksa Benefits Summary - USAKiniksa is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, transgender status, age, genetics, national origin, protected veteran status, or disability status, or any other legally protected category
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment
Please contact us to request accommodation.
