Senior Scientist of Operations (Part-time to Permanent Hire)

Job Description: Senior Scientist of Operations (Part-time to Permanent Hire)

We are seeking a Senior Scientist of Operations who will take an integral part of transitioning Milagen from a late-stage development company to a commercial-stage oncology diagnostic company. This person is an individual contributor part-time temp hire to start with the potential to convert to a permanent hire. Title will be based on experience: we may be open to a more senior title depending on the extent of relevant biomarker IVD/proteomics experience. This individual will report directly to the CEO of the Company. 

About us

Milagen is a privately held, late-stage, pre-commercial diagnostic company focused on commercializing easy-to-use, non-invasive, in vitro diagnostic products designed to fulfill unmet clinical needs in the prevention, detection, diagnosis, and management of major cancers. Milagen is in the final preparatory steps to seek regulatory validation of its Clinical Laboratory Improvement Amendments (CLIA) Laboratory and offer its products and testing services for early recurrence monitoring for breast and for colon cancer.

Responsibilities

  • Collaborate/communicate with academic/core lab institutions to finalize and compete other cancer test products that have been already discovered and validated for other clinical uses. 
  • Collaborate/communicate to acquire clinical samples from hospitals to complete ongoing studies for our 510K FDA submission. 
  • Update and re-submit current patent applications and manuscripts.
  • Analyzes and brainstorms alternative approaches to solve problems, makes recommendations and finds solutions to solve problems.  
  • Support internal and external audits. 

Requirements

  • Technical expertise with immunoassay (ELISA) and molecular technologies.
  • Experience managing CRO projects and knowledge of CLIA/GCLP practices is a plus
  • Excellent organization, writing, and communication skills
  • Collaborative spirit and ability to clearly communicate and adapt to change while working in a fast-paced environment
  • Proven track record of handling multiple high priority tasks in parallel with internal and external collaborators.
  • Demonstrated knowledge and experience with development, validation and troubleshooting and experience with broad range of specialty biomarker platform technologies: clinical chemistry, chemiluminescent technology/immunoassay (ELISA and Western-Blot), bio-analytical methods, and PCR molecular systems
  • Knowledge of FDA quality system regulations and processes.
  • Industrial diagnostic test development or support, Clinical Laboratory; Experience working in a regulated laboratory environment (CLIA, GLP/GCLP, IVD development).
  • Ability to manage and contribute effectively to multiple projects simultaneously.
  • Strong analytical, project management, and problem-solving skills
  • Ability to thrive in a small team that works hard but also enjoys sharing a laugh and having fun!

Qualifications

  • MD or /and Ph.D. with thesis (or equivalent); MS (or equivalent) with industrial experience and demonstration of capabilities and collaboration; BS with extensive industrial experience and significant demonstration of capabilities and collaboration
  • Prior application of biomarker/proteomics IVD in a translational/clinical setting is a plus; prior experience in oncology research is preferred
  • Startup minded: high energy, low maintenance, self-starter that is comfortable in a fast-paced environment
  • Cultural fit: genuine, collaborative, innovative, and goal-oriented

Milagen is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

 

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