Manager, Combination Product Development

Kiniksa Pharmaceuticals•Lexington, MA

11d•$134,000 - $152,000•Hybrid

About The Position

Kiniksa is seeking a highly motivated Manager, Combination Product Development to join our Drug Product Development team in Lexington, MA. Reporting to the Director, Combination Product Development, this individual will play a key role in developing Kiniksa’s drug-device combination products. 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.

Requirements

Requires a Bachelor's degree in mechanical or biomedical engineering related field of study with 6+ years of relevant industry experience; or Master’s degree (preferred) with 4+ years of relevant industry experience
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 Management
Previous experience with combination products is required, such as autoinjectors, co-packed kits, pre-filled syringes, inhalers
Ability to manage multiple priorities and work with ambiguity
Strong commitment to compliance and ethical standards
Ability to travel up to 5%

Responsibilities

Manage combination product design history file (DHF) functioning as SME on design control and risk management.
Manage external vendors and partners (CMDOs and device testing labs) to advance project milestones
Develop, manage, execute, and support human factors studies.
Conduct use-related risk assessments
Execute design verification and validation
Conduct impact assessments for Change Control, including DHF/RMF assessments
Author and review of regulatory submissions and responses
Assist in platform device selection and packaging design for new programs by performing feasibility tests
Summarize and communicate project updates to stakeholders

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume