• Job Description

  Req#: 5967

  Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

  Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

  Why Join Diasorin?

  • Impactful Work: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

  • Global Reach & Innovation: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

  Diverse and Inclusive Culture: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

  Join Our Team: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

  Are you ready to be part of a dynamic team that's shaping the future of diagnostics? Join Diasorin and become a catalyst for change in the world of healthcare. Apply today and be a part of our exciting journey toward a healthier, more connected world. Together, we can make an impact!

  Job Scope

  The Scientist Level 2 – Technical Operations is vital for all stages of the product development process and will lead transfer of new product designs to manufacturing beginning in the early stage of new product development through implementation and also include On-Market support activities post-product launch. This role's primary responsibilities will include coordination of the transfer of new product designs from R&D to manufacturing operations, including Bill of Materials (BOM), product design and configuration, product specifications, and QC test methods. The Scientist Level 2 – Technical Operations will be responsible for on-market product investigations and troubleshooting. This role will also lead the design, execution and interpretation of scientific activities for new method development and write reports, procedures and other documentation, including presenting to interdepartmental groups.

  Key Duties and Responsibilities:

  • Participate in collaborative efforts with R&D and specific process subject matter experts for successful transfer of new product designs, including product requirements, material specification development, and release specification development
  • Interface with cross-functional teams to ensure transfer of new products is completed according to agreed timelines
  • Ensure effective engagement with design teams and fulfillment of early design transfer responsibilities for new and changed product designs from prototype through market release phases
  • Ensure timely and effective knowledge transfer of science, technology, and application context behind new product designs being transferred into Reagent Manufacturing
  • Lead the development and validation of QC test methods and release specifications
  • Lead on-market product investigations through non-conformance investigations and CAPA processes, troubleshooting and root cause analysis activities, and R&D production of applicable reagents prior to Design Transfer to manufacturing
  • Collaborate with management in the release test methods and specifications for new products during design transfer activities and during market phase of released products
  • Independently prepare and present study results internally to project teams and site management
  • Perform engineering change control and document change control activities
  • Contribute to manufacturing process validation efforts, as applicable and the development of process automation strategies, as applicable
  • Independently design and conduct experiments in the laboratory and analyze scientific data in accordance with Good Laboratory Practices
  • Provide technical leadership, assistance, advice, and support both to department management and other scientific personnel
  • Participate in the maintenance of general laboratory organization

  Education, Experience, and Qualifications:

  • Bachelor's Degree in biological/chemical or related scientific disciplines with 7 years of relevant experience/training required or
  • Master's Degree in biological/chemical or related scientific disciplines with 5 years relevant experience/training preferred or
  • Ph.D. in biological/chemical or related scientific disciplines with 2 years relevant experience/training preferred
  • 2+ Years Quality Systems/Development, Process Improvement, Product Transfer, and/or product development focused experience in a relevant ISO 13485 and/or FDA regulated industry setting. required
  • 2+ Years Experience in a GMP, GLP and/or FDA regulated environment required
  • 3+ Years 3 years of Quality Systems/Development, Process Improvement, Product Transfer, and/or product development focused experience in the molecular diagnostics industry preferred
  • 2+ Years Experience in leading troubleshooting and root cause analysis preferred
  • 2+ Years Experience in leading CAPA investigations and CAPA management preferred
  • 2+ Years Strong theoretical and practical experience with a variety of standard nucleic acid laboratory procedures (end point reverse transcriptase PCR, real time PCR) preferred

  Training and Skills

  • Excellent interpersonal skills with proven ability to work both in a team-oriented environment and independently (High proficiency)
  • Excellent written and verbal communication skills (High proficiency)
  • Strong organizational and problem-solving skills (High proficiency)
  • Proficient in Microsoft Word, Excel, and PowerPoint programs. (High proficiency)
  • Proven time management and prioritization skills (High proficiency)
  • Ability to handle the pressure of meeting tight deadlines and adapting to rapidly changing priorities (High proficiency)
  • Working knowledge of Design Control requirements as defined by the FDA Quality System guidelines (Low proficiency)
  • Experience in Microsoft Project (Low proficiency)
  • Mathematics and statistics aptitude (Medium proficiency)
  • Data analysis and technical writing aptitude (Medium proficiency)

  Licenses and Certifications

  • Six Sigma certification preferred

  Standard Working Conditions

  • Must work onsite at Luminex office - Frequently
  • Possible exposure to biological or chemical hazard, and/or working with lasers - Frequently
  • Work situations include dealing with people; working alone; making judgments and decisions - Frequently

  Travel Requirements

  • 10% domestic travel may be required

  What we offer

  Receive a competitive salary and benefits package as you grow your career at DiaSorin. Join our team and discover how your work can impact the lives of people all over the world.

  Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

  In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

  Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities. If you are a US or Canada candidate and require assistance or accommodation during the application process, please contact the North America Talent Acquisition Team at hrtalent@diasorin.com or 1-800-328-1482 to request an accommodation.

  The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

  Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

  Please note that offers of employment at Diasorin may be contingent upon successful completion of a pre-employment background check and drug screen, subject to applicable laws and regulations.

  This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

• About the company

  DiaSorin is an Italian multinational biotechnology company that produces and markets in vitro diagnostics reagent kits used in immunodiagnostics and molecular diagnostics and since July 2021, it is also active in the Life Science business.

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