Director, Global Technical Transfer & Process Excellence

Hygiena; Camarillo (CA); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

15 days PTO & 10 paid holidays

Medical with HSA employer contribution

Company paid Life Insurance

Job summary

Hygiena, a leader in rapid microbiology diagnostics, seeks a Director, Technical Transfer & Process Improvement to lead global manufacturing science, process validation, and continuous improvement initiatives at its Camarillo, CA site. This senior management role oversees a diverse team and drives cross-functional projects across R&D, Quality, and Operations.

The ideal candidate has a strong background in cGMP, ISO 13485, Six Sigma, and proven success in launching regulated diagnostics products,

Qualifications

• Bachelor’s degree in a relevant field or equivalent education and work experience in a laboratory and manufacturing environment required.
• 10+ years of experience in lab or manufacturing with cGMP and quality investigations.
• 3+ years of supervisory experience managing direct reports.
• Expert knowledge of technical transfer, process piloting, gated product development systems, process validation, and documentation.
• ISO 9001/13485 systems knowledge, process validation, SOP authoring, and CAPA.

Responsibilities

• Serve as SME for establishing and piloting manufacturing processes for new product introductions.
• Lead investigations into complex product or process failures using structured problem-solving.
• Develop and execute IQ/OQ/PQ validation protocols for new equipment, processes, or materials.
• Support technical transfer from R&D to manufacturing to ensure CTQ and design intent is maintained.
• Lead a global team of manufacturing scientists, technical transfer specialists, and process improvement engineers.

Skills

Six Sigma Green/Black Belt

Supervisory experience

Technical transfer

Quality investigations

Education

Bachelor’s Degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, or related field

Tools

Microsoft Office

Adobe Acrobat

Job description

Hygiena, a leader in rapid microbiology diagnostics, seeks a Director, Technical Transfer & Process Improvement to lead global manufacturing science, process validation, and continuous improvement initiatives at its Camarillo, CA site. This senior management role oversees a diverse team and drives cross-functional projects across R&D, Quality, and Operations.

The ideal candidate has a strong background in cGMP, ISO 13485, Six Sigma, and proven success in launching regulated diagnostics products,