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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

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