Production Manager

DiaSorin; Cypress (CA); On-site; USD 128,700 - 174,100; Full time

Benefits offered by this job

Health benefits

Retirement plan

Paid time off

Wellbeing support

Annual incentive program

Job summary

DiaSorin is seeking a Diagnostics Specialist to lead manufacturing methods and operations for new or existing products. You will supervise hourly staff, oversee budgets and schedules, and ensure compliance with FDA/ISO requirements.

This role emphasizes Lean improvements, process transfer, and cross-functional collaboration with Cell Culture and Purification teams. The position offers a comprehensive benefits package and growth opportunities in a global diagnostics leader committed to patient

Qualifications

• 4+ years direct manufacturing supervision in ISO9001/13485 or cGMP.
• Experience with Six Sigma/Process Excellence tools preferred.
• Experience documenting processes and design transfer.
• Knowledge of cell culture, sterile products and protein purification preferred.

Responsibilities

• Insure timely and quality delivery of products and services to internal and external customers.
• Lead value improvement projects including Lean initiatives and production cell development.
• Use root cause investigation to address quality and scrap issues and implement corrective actions.
• Participate in technical transfer and maintenance of manufacturing processes.
• Collaborate with Cell Culture and Purification teams to scale up production.
• Develop standard cost models and track material/labor costs against standards.

Skills

Leadership

Project management

Analytical skills

Communication

Quality mindset

Education

Bachelor’s Degree (BA/BS) Required

Tools

MS Word

Excel

PowerPoint

Google Suite

Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.

Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.

As the Diagnostics Specialist, Diasorin continuously invests in research, technology and people. Guided by our values of operational excellence, customer focus and teamwork, we empower teams to think boldly, act decisively and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.

When you join Diasorin, you are not just filling a role. You are helping build what comes next.

Why Join Diasorin

• Build What Matters – Take ownership, challenge the status quo and contribute directly to solutions that improve patient care worldwide.
• Innovate with Agility at a Global Scale – Work in an entrepreneurial environment that enables speed, collaboration and global impact.
• Grow in a People-Centered Culture – Thrive in a culture that values accountability, inclusion and continuous development.

Job Scope

Responsible for directing the development, planning, implementation and maintenance of manufacturing methods, processes and operations for new or existing products and technologies. Ensures the effective use of material, equipment and personnel in producing quality products. May monitor and control labor and capital expenditures. May assist in developing budgets. Formulate and recommend manufacturing policies, procedures and programs. Write procedures, specifications, protocols, production records and other required documents. Support all applicable regulations including but not limited to FDA, ISO and CMD/CAS requirements.

Job Responsibilities and Duties

• Insure timely and quality delivery of products and services to both internal and external customers and be accountable for meeting objectives including production plans and budgets.
• Take an active role in value improvement projects, e.g., Lean Initiatives, quality, production cell development, equipment validations, new product launch production plans.
• Use sound root cause investigation to address quality and scrap issues and develop effective corrective actions for non-conformance issues identified by the quality system.
• Participate in the technical transfer, planning, implementation and maintenance of manufacturing processes including the transition of new products and processes.
• Work closely with Cell Culture and Purification development groups creating a team environment for the scale-up of production operations, processes and optimization of procedures.
• Identify problems, areas for improvement and provide input on technology transfer and support to engineering, PDP and technical support departments.
• Develop standard cost models and use of materials, labor and machines which affect standard costs in order to ensure performance at standards and to provide costing data for use in the annual budget process.
• Develop and revise operating metrics, manufacturing specifications and procedures, protocols, studies and other documents as needed, by the Company. Track performance to metrics as needed to insure attainment of company goals and blueprint.
• Lead and facilitate process improvement teams, managing the technical issues that affect the production floor, and identifying and implementing capital projects.
• Select, train and evaluate staff, maintain compliance in all safety, QSR, environmental and contract areas, and exercise direct supervision over various departments and production employees with respect to meeting production schedules and delivery dates.
• Analyze annual staff performance and conduct performance reviews.
• Manage Succession Plans to ensure efficient operation of department.
• Perform assigned tasks in accordance with applicable Environmental Health and Safety (EHS) regulations and Company EHS policies.
• Lead the manufacturing of raw material and its transformation into finished product through direct supervision and leadership of hourly manufacturing and other professionals.
• Develop and implement activities in production area(s) to meet production goals, quality and cost objectives.
• Ensure that team is properly trained in cGMPs, procedures, good documentation practices and regulatory matters.
• Monitor personnel practices to ensure compliance with SOPs, practices and regulations. Participate in design and implementation of training, cross‑training and development programs.
• Enforce all EHS policies in span of control.
• Perform other duties as assigned.

Education, Experience and Qualifications

• Bachelor’s Degree (BA/BS) Required
• 4+ Years direct manufacturing supervision experience in ISO9001, ISO13485 or cGMP environment, three (3) years in a biological products production facility subject to Good Manufacturing Practices (GMP) or Good Laboratory Practices (GLP) or an equivalent combination of related work experience Required
• Experience with Six Sigma/Process Excellence Tools, Training, and/or Certification Preferred
• Prior experience in developing new product documentation, processes and practices including design transfer responsibility. Required
• Working knowledge of cell culture, sterile products, protein purification, in‑vitro diagnostic production and technical knowledge of infectious bacteria, viruses and related products is preferred.
• Demonstrated leadership, facilitation and project management experience is required.
• Incumbent must have excellent written and oral communication skills and be able to exhibit strong leadership, interpersonal and teamwork skills.
• Ability to read, analyze and interpret general business periodicals, professional journals, technical procedures or governmental regulations. Ability to write reports, business correspondence and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
• Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference and volume. Ability to apply concepts of basic algebra and geometry.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral or diagram form. Ability to deal with problems involving several concrete variables in standardized situations.
• MS Word, Excel and PPT skills; familiarity with Google Suite

What we offer

The hiring range for this position is $128,700 - $174,100 annually. The salary range for this role represents the numerous factors considered in the hiring decisions including, but not limited to, educations, skills, work experience, certifications, etc. Beyond base salary, Diasorin offers a competitive rewards package focused on your overall well‑being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time‑off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including individual and organizational performance.

Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.

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, disability, protected veteran status or any other characteristic protected by applicable law.

This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights and employment conditions may apply based on local jurisdiction.

Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact [e-mail].

Recruitment Fraud Notice

Diasorin never requests payment, financial information or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact [e-mail] for verification.

Unauthorized third‑party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.