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 teams
Lead platform device evaluation, selection, packaging design, and development
Identify and maintain user needs with input from cross-functional teams
Develop, manage, and support execution of human factors studies
Lead planning and support execution of design verification and design validation studies
Conduct user related risk assessments and perform ethnographic analysis
Establish risk management strategies and associated documentation such as Hazard Analysis, Fault Tree, and FMEAs
Develop, author, review, and approve design control documents
Conduct impact assessments for change control, including design history file and risk management framework assessments
Author related sections in regulatory filing submissions (such as IND, IMD, BLA, MAA) and support responses to regulatory authority information requests
Manage oversight of external partners and CDMOs for combination product design, development, testing, and manufacturing
Support manufacturing investigations in collaboration with Quality, external partners, and subject matter experts
Summarize and communicate project updates to stakeholders
Stay current with the regulatory guidance, industry trends, and new emerging technologies as it relates to drug product development and manufacturing
Qualifications:
8-10+ year industry experience in device and combination product development
BS/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 analysis
Experience in biologics combination products such as autoinjectors, accessorized pre-filled syringes, and/or co-packed kits
Experience in technical oversight and collaboration with external partners and CDMOs
Experience in device and combination product analytical test methods
Effectively and concisely communicate scientific rationale and data to project teams
Demonstrated strong technical writing and data analysis skills
Experience with aseptic fill/finish operations for pre-filled syringes is preferred
Experience with inhalation delivery systems is a plus
Ability to manage multiple priorities and work with ambiguity to deliver results
Ability to travel up to 5%
Salary is commensurate with experience
Kiniksa Benefits Summary - USA
Kiniksa 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.