Morrisville, NC Other 1 week ago

The Kymanox Product Development team is seeking individuals with strong technical and/or operations backgrounds in the pharmaceutical/biotechnology industry.

Job Description:

Provide a broad range of project support to Kymanox clients, including technical, quality/compliance, manufacturing, and commercialization challenges. Experience with developing combination products and/or medical devices preferred. Basic responsibilities include:

  • Representing Kymanox to clients as a project core team member.
  • Providing technical leadership and direction to internal and external project teams.
  • Providing mentorship to junior staff, as part of projects or as direct reports.
  • Ensuring compliance to quality and regulatory standards and fostering a positive compliance culture.

Projects may include any of the following technical areas:

  • Providing technical evaluations and recommendations for mitigation(s) of challenges
  • Developing project roadmaps, detailed schedules, and overall project strategy
  • Authoring Design History Files, in real time or retrospectively.
  • Oversight of client testing activities, including combination product/medical device design verification and human factors testing.
  • CMO due diligence, evaluation, and client representation
  • Process improvement and troubleshooting, tech transfer
  • Project management
  • Regulatory evaluation, submission authorship and review
  • Data analysis, including statistical analysis
  • Product design (CAD, 3D printing)

Aptitude and Skill Set:

  • Versatile and adaptable technical skills
  • Able to execute high-profile activities with minimal supervision
  • Extremely detail-orientated and highly organized
  • Managerial (i.e., “do things right”) and leadership (i.e., “do the right thing”) skills
  • Strong professional presence and presentation skills
  • Excellent written and oral English communication skills
  • Fast learner with initial confidence tackling new material
  • Seasoned soft skills – high EQ and team player
  • Ability to work effectively with remote team members and/or direct reports
  • Ability to motivate self and others
  • Tackle problems proactively, not waiting for problems to grow unnecessarily
  • 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:

Bachelor’s degree in natural science (Chemistry, Biology, or similar) or engineering (Chemical, Biomedical, or Mechanical Engineering), or related technical discipline from an accredited institution. Advanced degree or industry certificates in project management (e.g., PMP, CAPM), six-sigma, quality, or regulatory affairs preferred but not required.

Experience:

3-6 years of experience in product development and/or manufacturing in the pharmaceutical, biotechnology, diagnostic, combination product, and/or medical device sectors is required.

Region:

Kymanox Corporate HQ in Durham (RTP), NC preferred. Chicago, IL; Boston, MA; King of Prussia, PA, Remote possible.

Travel:

Some travel may be necessary to support client work. If the candidate is not local to Kymanox headquarters in RTP, North Carolina, periodic visits (e.g.: 2 to 4 visits per year) may be required.

About Kymanox:

Join Kymanox and become a member of a dynamic, fulfilling team that helps a broad range of life science products get to market more quickly, more affordably, and with the highest quality and safety standards possible in today’s biotechnology, pharmaceutical, medical device, and combination product industries. With a reputation of providing unparalleled professional services and our highly collaborative team of engineering, compliance, and project management experts, Kymanox provides an outstanding opportunity for learning and career advancement. Kymanox encourages team members, especially new graduates and young professionals, to work on a variety of projects to gain increased learnings in Kymanox’s service offerings and the life science industry as a whole.

Kymanox is looking for motivated individuals who want to solve problems in the life science industries while doing the work they love and helping get modern medicines that enhance and save patient lives to market. Kymanox provides professional services related to engineering, compliance, and project management. We service clients ranging from Fortune 100 companies to virtual start-up companies. The company was founded in 2004 and has been growing steadily since its inception. Our corporate HQ is based in Research Triangle Park, NC, and we have offices in Boston, Chicago, and Philadelphia.

  • Company:
    Kymanox
  • Job Type:
  • Posting Date:
    11th May 2022
  • Valid through:
    11th Jun 2022
  • Location:
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. By applying to a job using RedHired you are agreeing to comply with and be subject to the RedHired Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.