Manufacturing Associate II, Reagents

at  DiaSorin

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!

EDUCATION, EXPERIENCE, AND QUALIFICATIONS:

Bachelors Degree in Chemistry, Life Science, Biotechnology, or Medical Technology related field
At least 3 years of relevant experience in a Life Sciences, Chemistry, Medical Technology, or Biotechnology industry
At least 1 year of relevant experience in an FDA regulated and/or ISO certified organization
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

THE PERSON IN THIS ROLE WILL BE RESPONSIBLE FOR:

Manufacturing un-modified and modified Oligonucleotides sequences within specification requirements as required by the production schedule. Work schedule may include alternate shifts.
Participating in manufacturing processes to support new product design transfer, stability program, process development, equipment alidations, process validations and investigations and resolution of product/process issues.
Monitoring and performing maintenance and calibration of Manufacturing measuring and monitoring devices as well as maintaining the integrity of work areas.
Updating work instructions and standard operating procedures as well as delivering associate change control. Training of new Manufacturing Associates
Frequent intra-department interaction as well as frequent inter-department interfaces.

KEY RESPONSIBILITIES AND DUTIES:

Manufacturing un-modified and modified Oligonucleotides sequences using AKTA synthesis and purification equipment at small scale (10µmol) and large scale (100µmol).
Performing in-process quality checks utilizing HPLC, Mass Spectrometry and UV-vis instrumentation along with micropipettes to prepare samples an aliquot product.
Deliver timely and accurate completion of manufacturing sections of process documentation using GDP and OraCal Inventory Management system.
Deliver timely and accurate completion of inventory cycle counts.
Document non-conformances per SOP instructions.
Support design transfer and integration of new products and processes.
Support process development and process improvements.
Participate in the writing and execution of equipment and process validations.
Support investigations and resolution of findings impacting the Oligonucleotide Manufacturing Operations identified through audits, non-conformances, corrective/preventive actions, or customer complaints escalation.
Deliver timely maintenance and calibration of assigned manufacturing measuring and monitoring devices.
Monitor select non-inventory supplies, maintain focused supplies, and generate purchase requisitions as needed.
Maintain cleanliness and integrity of manufacturing laboratory and storage areas.
Participate in applicable departmental and interdepartmental training; maintain current and effective training to standard operating procedures, work instructions, and applicable changes affecting Oligonucleotide Manufacturing.
Follow departmental and quality specific SOPs on daily basis.
Adhere to safety, disposal, and gowning requirements
Create and update departmental work instructions and standard operating procedures as required.
Perform change control as required to support change requirements including Engineering Change Orders, Document Change Control, and Deviations.
Assist in executing projects targeting efficiency, cost reduction, and quality improvements within scope of Bioassay Oligonucleotide manufacturing processes.
Participate in training department personal.
Other duties as assigned.