Senior Manager, Metrology

ElevateBio is a technology-driven company powering the industry forward by helping partners realize the potential of their therapies from design to commercialization. We have integrated a differentiated set of technologies, end-to-end services, and industry-leading manufacturing expertise to develop advanced therapies faster and more efficiently.

Here’s What You’ll Do

• Provide leadership for assigned duties at ElevateBio’s facility including overall supervision of associates and contractors performing calibrations, and various testing activities.


• Provide direction of group activities as necessary, resolution of problems/issues with contractors, vendors, and internal and external clients.


• Track and maintain progress towards completion of scheduled workloads, reassign resources to meet timelines.


• Review and approve departmental procedures, work orders, and reports. Drive systems improvements.


• Train and mentor staff on equipment, procedures, and systems.


• Work with System/Equipment owner to set Calibration Tolerances and ranges.


• Generate and revise SOP’s for Metrology program and equipment specific calibrations.


• Maintain a safe work environment for all employees, customers, and processes.


• Achieve a high level of service that will control costs, support cycle time, and maintain the quality, operation, integrity, and traceability of measurement equipment while meeting regulatory requirements. 


• Identify, report, and effectively resolve quality issues. Prepare for and support internal and external quality audits of metrology operations and equipment. Be a subject matter expert with ability to effectively communicate with internal and external auditors and investigator.


• Stay current on industry best practices to continuously improve laboratory operations. Develop knowledge retention and training program to ensure employees have the appropriate skills and capabilities to perform at a high level.

Requirements

• Bachelor’s degree and at least 8 years of related experience or Master’s degree with at least 6 years of related experience; or a PhD with at least 4 years of experience.


• Experience with Calibrating process, laboratory, packaging, and utility systems instrumentation/equipment in a GMP environment


• Ability to multitask and always maintain professionalism 


• Strong Microsoft Excel skills


• Proficient in Microsoft Office products (Outlook, Word, Excel, etc.)


• Experience working with Blue Mountain RAM or other CMMS programs preferred


• Ability to read, understand, and follow SOP, P&ID’s and work instructions


• Strong communication skills in both oral and written reports


• Reviewing GMP documentation for accuracy and compliance


• Participating in client, regulatory, and internal audits


• Have a working knowledge of industry guidelines


• Experience presenting and defending Calibration Program in Regulatory Audits.

Preferred Qualifications

• Nice to haves

Physical and Environment Requirements (if applicable):

• Ability to stand, walk, bend and stretch for extended period of time


• Ability to lift 25-50 lbs


• Ability to push, pull, bend, kneel, twist and climb step ladders while wearing PPE.


• Ability to perform routine repetitive motions with use of arms, wrists and hands

The budgeted range for this position is $150,000 - $200,000. This range is a good faith estimate of the expected salary range for this position, based on a wide range of factors including qualifications, experience and training, operational and business needs and other considerations permitted by law.