[Hiring] Combination Product Senior Engineer or Scientist @Kymanox

Role Description

The Kymanox Product Development & Commercialization team is seeking a Combination Product Senior Engineer or Scientist with a strong technical and/or operations background in the pharmaceutical, biotechnology, diagnostics, or medical device industries. Ideal candidates will build on their proven past performance supporting complex product development or life cycle management programs involving injectable drug-device combination products (i.e., autoinjectors).

Utilizes technical expertise and project management skills to support client development projects for autoinjectors. Basic responsibilities include:

• Writing technical documentation with minimal direction.
• Acting as a technical lead on small programs or leading workstreams on larger programs.
• Working cross-functionally within and outside Kymanox.
• Representing Kymanox and work product in client-facing meetings.
• Basic project management (i.e., meeting minutes, schedules, correspondence).

Projects may include any of the following technical areas:

• Creating technical documentation supporting product development efforts, including testing protocols/reports, design and development files, and technical files.
• Technology evaluation, due diligence, and selection.
• CMO due diligence, evaluation, and client representation.
• Regulatory submission authorship.
• Conducting testing activities, including combination product and medical device design verification and human factors testing.
• Statistical analysis of development and production data.

Qualifications

• Minimum bachelor's degree in natural sciences (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution.
• Early career master's and Ph.D. level candidates encouraged to apply.
• Industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

Requirements

• 5-10 years of experience (including advanced degrees) in product development and/or manufacturing of injectable combination products is required.
• Expert level understanding and application of ISO 11608 series and other applicable standards for autoinjector development is required.
• Demonstrated contributions to complex, multi-disciplinary development programs, pharmaceutical (drug product) development, in vitro diagnostic development, clinical development, or electromechanical systems development is desirable.

Benefits

• Medical healthcare including dental and vision.
• Short- and long-term disability.
• Life insurance.
• Matching 401(k) retirement plan.
• Continuing education assistance.
• Other benefits.