Injectable Combination Product Senior Engineer or Scientist

Job Description

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.

Aptitude and Skill Set:

• Versatile and adaptable technical skills
• Positive attitude, and welcomes new challenges
• Flexible to be present at client sites and sometimes travel
• Able to execute activities with minimal supervision, manages time wisely
• Strong professional presence and presentation skills
• Extremely detail-orientated and highly organized
• Excellent written and oral English communication skills
• Comfortable providing feedback and influencing internal and external stakeholders
• Emotionally stable and can navigate challenging clients and situations
• Seasoned soft skills – high EQ and team player
• Ability to work effectively with remote team members
• Tackle problems proactively
• A mindset of innovation and creativity
• Computer and IT savvy
• Thrive in a fast-paced, growing, and dynamic work environment
• Expertly solicit and utilize subject matter expert input
• Value and understand quality
• Uncompromised honesty and integrity

Educational Background:

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.

Experience:

• 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.

Region:

Remote.

Travel:

Travel may be necessary to support client work. Periodic visits (e.g. 1-2 visits per year) to Kymanox office(s) are required.

Career Development:

The position will evolve over time and more responsibilities may be added. Since Kymanox is a growing company, there are opportunities for advancement both within the currently defined role and in other functions within the organization.