Meta AR/VR Job | Biocompatibility Lab Manager
Job（岗位）: Biocompatibility Lab Manager
Type（岗位类型）: Operations
Citys（岗位城市）: Sunnyvale, CA
Date（发布日期）: Before 2021-12-14
Summary（岗位介绍）
Facebook Reality Labs (FRL) is looking for a strong analytical expert with demonstrated experience in setting up and managing biocompatibility analytical testing lab for material characterization and finished product testing following ISO-10993 standards. FRL biocompatibility testing lab will be responsible for all FRL wearable and non-wearable products. Responsibilities include lab design, equipment procurement, setup and management, biocompatibility testing of material and finished FRL products, setting up methods, building processes and SOP’s, representing analytical in cross functional teams, obtaining and maintaining pertinent lab certifications and also provide training to contract worker and employees.
Qualifications（岗位要求）
Ph.D. in chemistry or related field with 3+ years experience in a related industry or BS/MS in chemistry or related field with 7+ years of experience in a related industry
Understanding and experience in ISO 10993 standards for sample preparation, material characterization, extractable and leachable testing and methods for identified materials of concern
Experience running a biocompatibility/analytical testing laboratory
Experience with analytical techniques including HPLC, LC/MS, ICPMS, GC/MS, spectrometry
Knowledge of current Good manufacturing Practices (cGMP)
Knowledge of biocompatibility related standards and regulatory guidance including ISO10993, MDR, ICH, USP, EP and FDA
Experience working in fast paced, collaborative, cross functional environment
Experience communicating and presenting clearly to technical and non-technical audience
Description（岗位职责）
Set up state-of-the-art biocompatibility testing laboratory, obtain and maintain pertinent lab certifications
Manage and maintain analytical lab equipment (including HPLC, ICPMS, LC/MS, GS/MS) and workflow to meet the biocompatibility testing needs of FRL
Manage and execute biocompatibility testing strategies for materials and products to address key biocompatibility endpoints/gaps keeping in mind program timelines and working closely with internal and external test labs as needed
Build in house sample preparation and material characterization capabilities following ISO 10993
Engage with biocompatibility experts to identify materials of concern and develop detection methods following standard/regulatory recommendations
Manage biocompatibility testing at external contract testing labs including sample submission, protocol review and data quality, interpretation, and report review
Lead and support FRL biocompatibility testing needs including extractable and leachable testing, analysis and trouble-shooting
Build procedures, processes, and systems to streamline sample preparation, testing capabilities and deliverables
Engage and communicate with FRL leaders on biocompatibility testing specific topics
Additional Requirements（额外要求）
Experience with particle size analysis
Experience setting up a biocompatibility/analytical testing laboratory
