Senior Manager, Manufacturing Operations

**Company Description**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, visitand follow the company on,and.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.**Essential Duties and 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; and* Coordinate with QA and the Engineering team to design, plan, document, and conduct IQ/OQ/PQ for manufacturing and quality control testing equipment.**Qualifications:*** 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; and* Ability to work as part of a team.**Work Environment:*** Hours and days may vary depending on operational needs;* Standing or sitting for long periods of time may be necessary;* Exposure to hazardous materials, blood specimens and instruments with moving parts, heating or freezing elements, and high-speed centrifugation;* Repetitive manual pipetting may be necessary; and* Some lifting (up to 25 pounds) may be necessary.#LI-MG2**Hybrid Work Model:****This section is applicable to onsite employees who are eligible for hybrid work location as specified by management and related policies.

Guardant has defined days for in-person/onsite collaboration and work-from-home days for individual-focused time. All U.S. employees who live within 50 miles of a Guardant facility will be required to be onsite on Mondays, Tuesdays, and Thursdays. We have found aligning our scheduled in-office days allows our teams to do the best work and creates the focused thinking time our innovative work requires. At Guardant, our work model has created flexibility for better work-life balance while keeping teams connected to advance our science for our patients.** The annualized base salary ranges for the primary location and any additional locations are listed below. This range does not include benefits or, if applicable, bonus, commission, or equity. Each candidate’s compensation offer will be based on multiple factors including, but not limited to, geography, experience, education, job-related skills, job duties, and business need.Primary Location: Redwood City, CAPrimary Location Base Pay Range: $136,000 - $187,000Other US Location(s) Base Pay Range: $115,600 - $158,950If the role is performed in Colorado, the pay range for this job is: $122,400 - $168,300*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 #J-18808-Ljbffr