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.
Responsibilities (including, but not limited to):
- 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
Qualifications and Experience:
- 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%
- Salary is commensurate with experience
- Kiniksa Benefits Summary - USA
The pay range for this position is $134,000 - $152,000. Compensation is subject to change commensurate with industry standards and the candidate's relevant experience and qualifications.
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.
