With rapid growth comes opportunity. We are looking for an **Director, Technical Transfer & Process Improvement** to join our team onsite in our Camarillo, CA office! This is a full-time / exempt position. **Responsibilities:** Process & Product Support - Serve as the technical SME for establishing and piloting manufacturing processes for new product introductions. - Partner with Operations to investigate and resolve in-process deviations, fill-volume variation, contamination, and product performance issues. - Lead on-floor studies and process Kaizens to verify hypotheses and drive sustainable process improvements. Product Quality Investigations - Root-Cause Analysis & Corrective Actions - Lead or support investigations into complex product or process failures using structured problem-solving. - Design and execute laboratory experiments to confirm root causes and verify potential solves. - Work within a matrixed structure with R&D, Quality, and Operations to implement CAPAs that address systemic issues. - Prepare detailed technical reports summarizing findings, statistical analyses, and recommendations. Generate time-based quality data trending to help identify areas for improvement. - Ensure that investigations stay properly structured, appropriately scoped, and promptly executed in a disciplined manner. Process Validation & Technical Transfer - Develop and execute validation protocols (IQ/OQ/PQ) for new equipment, processes, or materials. - Serve on technical project teams late in development to become proficient with the product in order to robustly support technology transfer from R&D to manufacturing, ensuring design intent and CTQ aspects are maintained. Create, improve, and oversee a systemology and set of best practices for technical transfer. - Formulate, review, and approve pilot validation reports, ensuring compliance with ISO 13485 and Hygiena's quality system requirements. - Participate in process qualification activities for new manufacturing equipment. - Create, validate, and troubleshoot production processes linked to product manufacturing across our global production organization. Continuous Improvement - Drive continuous improvement projects aligned with corporate quality and operational excellence goals across the global organization. - Apply Lean and Six Sigma methodologies to optimize processes and reduce variation and waste. - Collaborate across global sites to harmonize best practices, procedures, and work environments. - Monitor and trend process data to proactively identify opportunities for improvement. Team Leadership - Responsible for managing and directing a global team of manufacturing scientists, technical transfer specialists, and process improvement engineers - Lead a highly visible, multi-functional team in building a robust, structured, and disciplined portfolio progression function - Lead our global operational excellence culture - Ensures compliance with and/or follows all organizational systems, programs, training, policies, and procedures as required and complies with relevant legal mandates. Seeks guidance as necessary. - Actively supports and participates in the safety program, both for self-protection and the protection of other employees, by reading and abiding by all requirements in the Safety Manual and Injury Illness Prevention Program (IIPP). - Carries out all responsibilities in an honest, ethical and professional manner. - Must be able to fulfill essential job function in a consistent state of alertness and safe manner. - Handles various other duties as delegated by the CSO. **Supervisory Responsibilities:** In accordance with applicable policies/procedures and Federal/State laws, may perform the following supervisory responsibilities: Interviewing, hiring, orienting and training employees; planning, assigning, and directing work; coaching and appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; enforcing all safety rules and ensuring safe work procedures. **Qualifications:** - Bachelor's Degree in Biology, Microbiology, Biochemistry, Chemistry, Engineering, or a related field, or equivalent education and work experience in a laboratory and manufacturing environment required. - Minimum of ten (10) years of experience of increasing responsibility working in a laboratory or manufacturing environment required that includes the following: cGMP, aseptic technique, and quality investigations. - Minimum of three (3) years of supervisory experience managing direct reports required. - Expert knowledge of technical transfer; including process piloting, gated product development systems, process validation, and documentation - Strong understanding of ISO 9001/13485 systems, process validation, SOP authoring, and CAPA - Hands-on proficiency in both laboratory and manufacturing settings, including mastery of aseptic techniques - Demonstrated success in launching regulated products in the diagnostics industry. - Demonstrated success in leading investigations and implementing data-driven improvements using statistical and analytical tools - Six Sigma Green or Black Belt Certification - required - Hands-on experience working in or closely with R&D - Intermediate knowledge of Microsoft Office (Outlook, Word, Excel, Visio, PowerPoint) and Adobe Acrobat required. **Salary Range:** $150,000 - $190,000 annually + bonus **Benefits and Perks:** - 15 days of PTO & 10 paid company holidays - Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date - Company paid Life Insurance, Short* and Long-Term Disability and an Employee Assistance Program - 401(k) with Safe Harbor and Profit-Sharing employer contributions - Tuition Reimbursement program - Charitable Contribution matching - Employee Referral bonus opportunities *State paid short-term disability for California based employees