Director, Manufacturing Operations
- 505 Penobscot Dr, Redwood City, CA 94063, USA
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets and advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory and reimbursement to drive commercial adoption, improve patient clinical outcomes and lower healthcare costs. In pursuit of its goal to manage cancer across all stages of the disease, Guardant Health has launched multiple liquid biopsy-based tests, Guardant360 and GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence and early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies and all 27 of the National Comprehensive Cancer Network centers.
The Director of Manufacturing Operations is responsible for working cross functionally to manage and scale reagent manufacturing, quality control, materials management, warehousing, incoming quality control, and technology transfer of new methods ensuring an uninterrupted supply of materials on a global scale. This includes resolving production-related issues, overseeing day-to-day operations, and scaling of manufacturing & QC within the California HQ facilities, and beyond. Responsible for monitoring the performance of personnel and providing direction to ensure both individual and departmental objectives are met. Must be able to act as a company representative to auditors, vendors, and clients.
Essential Duties and Responsibilities:
- Supervise and manage all functions of Manufacturing Operations.
- Work with Senior Management to align corporate and operational strategies.
- Identify, recommend and implement changes to improve productivity and reduce cost and scrap, monitor scrap and rework data. Direct the establishment, implementation and maintenance of production standards.
- Collaborate with Tech Development to meet departmental goals and ensure effective transfers of new products into production that meet quality requirements.
- Develop and implement SOPs for daily operations and process improvement.
- Perform audits to measure departmental productivity and quality, and to ensure regulatory compliance.
- Establish, monitor and communicate Manufacturing & QC metrics. Drive continuous improvement projects to create robust, scale-able, and standardized processes.
- Expand reagents production and analytical capabilities as needed to meet reagents product roadmap, including evaluating and facilitating Contract Manufacturing Organizations to supplement global distribution.
- Collaborate with Quality and Regulatory peers to meet US FDA & international regulatory requirements.
- Bachelor's degree in Biochemistry, Chemistry, Chemical Engineering, Molecular Biology or equivalent of experience.
- 8+ years experience as a manager or director in manufacturing management, preferably in a process-oriented operations in a laboratory, biotech or healthcare facility.
- Experience with packaging and distribution on a global scale.
- Experience with cGMP manufacturing practices, such as 21 CFR Part 820. Experience in a FDA or ISO certified manufacturing setting
- Ability to work with self-discipline, good judgment and independence.
- Excellent written, verbal communication skills are required.
- Proficiency in computer office applications.
- Able to travel both domestically and internationally on a periodic basis.
Employee may be required to lift routine office supplies and use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, and biohazard material in the laboratory environment. Ability to sit for extended periods of time.
Guardant Health 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, or protected veteran status and will not be discriminated against on the basis of disability.
All your information will be kept confidential according to EEO guidelines.
Please visit our career page at: http://www.guardanthealth.com/jobs/
#LI-PD1 #cancer #preventativemedicine #earlydetection #precisionmedicine #oncology #guardanthealth