Senior Manager, Metrology

ElevateBio•Waltham, MA

8h•Onsite

About The Position

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.

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.)
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.

Nice To Haves

Experience working with Blue Mountain RAM or other CMMS programs preferred
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

Responsibilities

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.