Manager OR Senior Manager, R&D Product Transfer - AID

Werfen North America; San Diego (CA); On-site; USD 95,000 - 170,000; Full time

Job summary

Werfen North America is seeking a Manager for Product Development and Design Transfer in San Diego, CA. This role includes overseeing the transfer of new products from R&D to Manufacturing, ensuring compliance with FDA and ISO guidelines, and driving improvements throughout the product lifecycle.

The ideal candidate holds a PhD or M.S. in Chemistry with over 10 years of experience in a leadership role in the In-Vitro Diagnostics industry, and possesses strong project management skills.

Qualifications

• 10+ years of progressive management and leadership experience, preferably in In‑Vitro Diagnostics.
• Considerable hands‑on experience in Medical Device manufacturing.
• 8+ years of conducting investigations.

Responsibilities

• Manage the R&D Product Transfer department.
• Coordinate all new product development and transfer activities.
• Lead the product transfer process ensuring RA and QA compliance.
• Use statistical and risk management techniques in product development.
• Troubleshoot product complaints and lead CAPA investigations.

Skills

Immunoassay experience (bead-based or Luminex technology)

Strong knowledge of Design Control elements

Experience with DOE and other statistical programs

Strong project management and Lean Six Sigma skills

Excellent communication, interpersonal, and leadership skills

Education

PhD or M.S. in Chemistry or related field

Job description

Werfen is a growing, family‑owned company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. Our headquarters and technology centers are located in the US and Europe and our workforce is more than 7,000 strong.

Job Summary

This position is responsible for product development and design transfer activities for new products from R&D to Manufacturing. The manager leads the transfer of new products coming from R&D or an external party to the different operations areas. Post‑launch, the department addresses performance issues and improvements throughout the product life cycle.

Responsibilities

• Manage the R&D Product Transfer department.
• Coordinate and direct all new product development and transfer activities, ensuring execution of process development and validation studies.
• Lead the product transfer process and associated design control requirements, ensuring RA and QA compliance with FDA, ISO, and IVDR guidelines.
• Use statistical and risk management techniques in product development and design of manufacturing process flow.
• Coordinate with Value Stream Leaders to ensure compliance with standard operating practices.
• Ensure group leaders have all resources (tools, training, information) to implement activities on time.
• Drive excellence in manufacturing processes, efficiency, and productivity, meeting all quality and regulatory requirements.
• Troubleshoot product complaints and non‑conformances, lead CAPA investigations and corrective actions pertaining to assay specifications and performance issues.

Qualifications

• PhD or M.S. in Chemistry or related field.
• 10+ years of progressive management and leadership experience, preferably in In‑Vitro Diagnostics or autoimmunity.
• Considerable hands‑on experience in Medical Device manufacturing with strong knowledge of FDA QSR, IVD‑R, and ISO 13485.
• 8+ years of conducting investigations (5+ years for Manager level).

Skills & Capabilities

• Immunoassay experience (bead‑based or Luminex technology).
• Strong knowledge of Design Control elements and substantial experience with product development and design transfer activities.
• Experience with DOE and other statistical programs.
• Strong project management and Lean Six Sigma skills (DMAIC, Kanban, FMEA, 5S, RACI).
• Excellent communication, interpersonal, and leadership skills.

Salary

The annual base salary range for this role is $95,000 to $170,000 for the Manager level and $135,000 to $195,000 for the Sr. Manager level. Individual compensation will depend on education, relevant experience, and business needs.

Equal Opportunity Employer

Werfen is an Equal Opportunity Employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment, or retaliation based on any protected characteristic as defined by applicable state or federal law.

If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.