R&D Product Transfer Leader – Diagnostics & Manufacturing

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 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.