Company Description|Job Description
Guardant Health is a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary blood tests, vast data sets & advanced analytics. Its Guardant Health Oncology Platform is designed to leverage its capabilities in technology, clinical development, regulatory & reimbursement to drive commercial adoption, improve patient clinical outcomes & 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 & GuardantOMNI, for advanced stage cancer patients, which fuel its LUNAR development programs for recurrence & early detection. Since its launch in 2014, Guardant360 has been used by more than 6,000 oncologists, over 50 biopharmaceutical companies & all 27 of the National Comprehensive Cancer Network centers.
The Associate Director of Manufacturing is responsible for the daily oversight of manufacturing operations, build schedules & personnel management.The Reagent Manufacturing Associate Director is responsible for providing oversight & management of the manufacturing of reagents, assembling of kits, & qualification activities of assigned reagents for internal & external international distribution. The Reagent Manufacturing Associate Director follows Good Manufacturing Practices (cGMP) & documents events following current Good Documentation Practices (GDP). The Reagent Manufacturing Associate Director will act as a liaison between cross functional departments.
The Associate Director of Manufacturingwill also be involved with troubleshooting, coaching & mentoring the manufacturing staff, building effective teams, managing projects & meeting project deliverables, & understanding & implementing manufacturing goals.
The Associate Director ensures manufacturing staff are correctly trained on all processes. The Associate Director demonstrates good judgment, sound analysis & decision making, the ability to remain professional & composed under pressure & the ability to communicate effectively across levels & functions in a team environment. The Associate Director complies with all applicable local, state & federal laboratory requirements & operates under the direction of the Laboratory Director & Senior Director of Clinical Operations.
- Oversee Reagent Manufacturing department & daily operations including build schedules, inventory & resolving technical & non-technical issues;
- Perform administrative duties including hiring, training, employee performance evaluations, writing & reviewing work instructions, protocols, forms, & equipment maintenance forms as assigned;
- Coach & mentor Reagent Manufacturing Associates by providing guidance, constructive feedback & assistance with the development of skills;
- Lead in interdepartmental activities with Clinical Operations, Quality Assurance, Quality Control, Technology Development, Engineering, Bioinformatics & Supply Chain Management to ensure an uninterrupted supply of qualified reagents;
- Participate in assay improvements, new assay configurations & validations byreview of detailed work instructions & process maps for IVD reagent manufacturing & QC, including procedures for reagent manufacturing & quality control testing, BOMs, process flow diagrams, raw material specifications, & protocols & reports for studies required to transfer reagent products into production;
- Participate in inspection preparation & inspections as needed;
- Maintain sufficient inventory of material, supplies & equipment in the laboratory for performance of duties;
- Partner with the Global Supply Chain team to identify, evaluate & manage material suppliers, manufacturing equipment vendors, & contract manufacturers;
- Maintain stringent standards for quality, identifying any issues which might adversely impact the quality of test results and/or employee safety, & 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 & effective execution of relevant risk management activities, including manufacturing process FMEAs & the resulting definition of required supplier controls & manufacturing process controls; and
- Coordinate with QA & the Engineering team to design, plan, document, & conduct IQ/OQ/PQ for manufacturing & quality control testing equipment.
- Minimum Bachelor's degree or equivalent in Biomedical Laboratory Science, Clinical Science or related field preferred with 8+ years' of experience in related field; OR
- Strong working knowledge of ISO 13485 and/or other applicable regulatory requirements for medical devices such as PMA & 510(k);
- Previous experience in leading a variety of essential activities, including reagent qualification, inventory management, procedure writing, inspection preparation, process validation & investigation;
- Previous manufacturing in cGMP laboratory experience required;
- Previous involvement in design, development, documentation, validation of analytical/functional test methods for quality control.
- Experience with Process Validations & transferring of new manufacturing processes & associated risk management processes for medical in vitro diagnostic (IVD) products under ISO 13485 and/or FDA 21CFR820;
- Understanding of Next Generation Sequencing processes & 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 & customers as needed;
- Ability to prioritize & adapt to changing priorities while maintaining a high-quality standard;
- Ability to work in a fast-paced, multidisciplinary & dynamic environment, managing multiple activities simultaneously; and
- Ability to work as part of a team.
- Hours & days may vary depending on operational needs;
- Standing or sitting for long periods of time may be necessary;
- Exposure to hazardous materials, blood specimens & instruments with moving parts, heating or freezing elements, & high-speed centrifugation;
- Repetitive manual pipetting may be necessary; and
- Some lifting (up to 25 pounds) may be necessary.
Employee may be required to lift routine office supplies & use office equipment. Majority of the work is performed in a desk/office environment; however, there may be exposure to high noise levels, fumes, & 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 & 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/