What are the responsibilities and job description for the Senior Process Scientist position at DiaSorin?
For over 40 years, DiaSorin has been on a mission on five continents to develop, produce and commercialize diagnostic tests for a wide range of clinical areas. Our tests are designed for hospitals and private testing laboratories, in the markets of immunodiagnostics and molecular diagnostics.
We believe in a respectful and supportive workplace that attracts and celebrates the uniqueness of a diverse workforce that represents our community and customers.
Position Summary
This position is responsible for activities involved in maintaining raw material supplies and completing raw material approvals. This position is responsible for manufacture and quality control testing of antibodies, esters, conjugates, peptides and purified proteins for further use in manufacture of in-vitro diagnostic products.
Key Duties and Responsibilities
1. Analyze testing results of raw material evaluations and technical manufacturing, quality control or product performance to determine acceptability of product relative to established requirements.
2. Assist with personnel training functions.
3. Prepare, provide, present and/or participate in written or verbal input to department and/or interdepartmental product teams.
4. Participate in departmental meetings to report on product manufacturing progress, set priorities and negotiate any schedule conflicts to provide timely completion of work with accurate results.
5. Participate in Product Improvement Teams or product development core teams as needed to assist with and provide input into manufacturing processes, raw material selections, and testing protocols.
6. Write/Complete Validation plans, reports and activities to comply with GMP requirements and DiaSorin policies.
7. Contribute to business continuity or continuous improvement projects by:
* Suggesting improvements and completing assigned tasks.
* Executing investigations where needed, defining project/scope and writing quality plans
and/or validation plans.
* Leading projects, training others on tasks, and ensuring implementation of projects.
8. Write or maintain procedures as required and review procedures from other departments.
9. Participate in inventory accountability activities as needed.
10. Execute investigations for root cause determination and troubleshoot product or process issues.
11. Lead and train others in writing and execution of validation plans and reports.
12. Own and lead CAPA investigations
13. Help with higher level employee training such as theory of immunoassay, principles of
different assay types, etc.
Education, Experience, and Qualifications
* Bachelor's or Master's degree in Chemistry, Biology, Medical Technology or related science field or a 2 year degree (i.e. MLT) with equivalent experience
* 5 years of related laboratory experience and/or demonstrated competence within the in-
vitro diagnostic industry
* Basic understanding of immunology and immunoassay techniques
* Basic understanding of protein purification, analysis and modification techniques
* Ability to work in a regulated environment
* Working knowledge of general lab equipment (e.g. pH meter, balances, mixers, etc.)
* Working knowledge of MS Excel; familiarity with Google Suite
* Ability to work with minimal supervision
* Knowledge of statistical analysis and reporting methods
* Ability to train team members on basic group procedures and tasks
* Advanced skills in math and calculations, writing and documentation skills, analytical skills
and ability to grasp complex concepts and solutions.
Working Conditions Physical Demands, Travel, etc.
* Travel: Not typical
* Periodic Overtime during the week, and weekend.
* Correctable Vision (inspection work) and Ability to Distinguish Color (Label Inspection)
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.
We are an equal opportunity employer that values diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply.
This contractor and subcontractor shall abide by the requirements of 41 CFR 60-1.4(a), 41 CFR 60-300.5(a) and 41 CFR 60-741.5(a). These regulations prohibit discrimination against qualified individuals. based on their status as protected veterans or individuals with disabilities, and prohibit discrimination against all individuals based on their race, color, religion, sex, sexual orientation, gender identity or national origin. Moreover, these regulations require that covered prime contractors and subcontractors take affirmative action to employ and advance in employment individuals without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.
DiaSorin Inc and DiaSorin Molecular LLC are Affirmative Action and Equal Opportunity Employers. 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.
Equal Employment Opportunity
Posters:https://www.dol.gov/agencies/ofccp/posters.
If you'd like to view a copy of the company's affirmative action plan or policy statement, please email:. If you have a disability and you believe you need a reasonable accommodation in order to search for a job opening or to submit an online application, please e-mail:or call toll-free 1.800.328.1482.
