Senior Manager, Manufacturing Operations

Guardant Health•Redwood City, CA

45d•Hybrid

About The Position

Guardant Health is a leading precision oncology company focused on guarding wellness and giving every person more time free from cancer. Founded in 2012, Guardant is transforming patient care and accelerating new cancer therapies by providing critical insights into what drives disease through its advanced blood and tissue tests, real-world data and AI analytics. Guardant tests help improve outcomes across all stages of care, including screening to find cancer early, monitoring for recurrence in early-stage cancer, and treatment selection for patients with advanced cancer. For more information, visit guardanthealth.com and follow the company on LinkedIn, X (Twitter) and Facebook. The Senior Manager of Reagent Manufacturing is responsible for the daily oversight of manufacturing operations, build schedules and personnel management. The Reagent Manufacturing Senior Manager is responsible for providing oversight and management of the manufacturing of reagents, assembling of kits, and qualification activities of assigned reagents for internal and external distribution. The Reagent Manufacturing Senior Manager follows Good Manufacturing Practices (cGMP) and documents events following current Good Documentation Practices (GDP). The Reagent Manufacturing Senior Manager will act as a liaison between cross functional departments. The Senior Manager of Reagent Manufacturing will also be involved with troubleshooting, coaching and mentoring the manufacturing staff, building effective teams, managing projects and meeting project deliverables, and understanding and implementing manufacturing goals. The Senior Manager ensures manufacturing staff are correctly trained on all processes. The Senior Manager demonstrates good judgment, sound analysis and decision making, the ability to remain professional and composed under pressure and the ability to communicate effectively across levels and functions in a team environment. The Senior Manager complies with all applicable local, state and federal laboratory requirements and operates under the direction of the Laboratory Director and Senior Director of Clinical Operations.

Requirements

Minimum Bachelor’s degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred with 8+ years of management experience in related field
Strong working knowledge of ISO 13485, 21CFR 820, and/or other applicable regulatory requirements for the manufacturing of medical devices
Previous experience in leading a variety of essential activities, including reagent qualification, inventory management, procedure writing, inspection preparation, process validation and investigation
Previous experience manufacturing in cGMP laboratory required
Previous involvement in design, development, documentation, and validation of analytical/functional test methods for quality control.
Experience with Process Validations and transferring of new manufacturing processes and associated risk management processes for medical in vitro diagnostic (IVD) products under ISO 13485 and/or FDA 21CFR820
Understanding of Next Generation Sequencing processes and automated workflows
Previous experience with direct management responsibilities including hiring, professional development, & training
Strong communicator with ability to maintain open communication with internal employees, managers and customers as needed
Ability to prioritize and adapt to changing priorities while maintaining a high-quality standard
Ability to work in a fast-paced, multidisciplinary and dynamic environment, managing multiple activities simultaneously
Ability to work as part of a team

Responsibilities

Oversee Reagent Manufacturing department and daily operations including build schedules, inventory and resolving technical and non-technical issues
Perform administrative duties including hiring, training, employee performance evaluations, writing and reviewing work instructions, protocols, forms, and equipment maintenance forms as assigned
Coach and mentor Reagent Manufacturing Supervisors and Associates by providing guidance, constructive feedback and assistance with the development of skills
Lead in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control, Technology Development, Engineering, Bioinformatics and Supply Chain Management to ensure an uninterrupted supply of qualified reagents
Participate in assay improvements, new assay configurations and validations by review of detailed work instructions and process maps for IVD reagent manufacturing and QC, including procedures for reagent manufacturing and quality control testing, BOMs, process flow diagrams, raw material specifications, and protocols and reports for studies required to transfer reagent products into production
Participate in inspection preparation and inspections as needed
Maintain sufficient inventory of material, supplies and equipment in the laboratory for performance of duties
Partner with the Supply Chain Management team to identify, evaluate and manage material suppliers, manufacturing equipment vendors, and contract manufacturers
Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, and communicating these to the appropriate management representatives as necessary for resolution
Document all corrective actions taken when test systems deviate from the established performance specifications
Ensure timely and effective execution of relevant risk management activities, including manufacturing process FMEAs and the resulting definition of required supplier controls and manufacturing process controls
Coordinate with QA and the Engineering team to design, plan, document, and conduct IQ/OQ/PQ for manufacturing and quality control testing equipment