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    Bio-Manufacturing Manager

    Zachary Piper Solutions, LLC
    Gaithersburg, MD 20877
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    Job Description

    Piper Companies is currently seeking a Manufacturing Manager for an innovative biotechnology company focused in cancer research in the Gaithersburg, MD area. Responsibilities for the Manufacturing Manager include Comply with Manufacturing Management team and Quality Assurance to ensure a level of compliance with cGMP with respect to the storage, use, and documentation activities associated with the manufacture of bulk and finished product. Ensures the ongoing validated state of cGMP manufacturing processes as it relates to process performance. Actively participates in and coordinates the installation, operation, cleaning, and maintenance of bio-pharmaceutical cGMP equipment. Demonstrates, understands, and adheres to APT policies, GMP standards, and safety procedures. Coordinates daily tasks with Group Leads and ensures completion. Works effectively with manufacturing personnel to build team relationships. Establishes and maintains routine management tools and standards to assure that direct reports are utilizing common tools to track resources, time coding, and performance. Generates batch records, SOPs, and other controlled documentation as assigned by the Manufacturing Management Team. Promotes collaboration with supporting departments to aid in manufacturing initiatives and achieve company goals. Actively supports the internal audit program as a means of driving continuous improvement throughout Manufacturing. Ensures department compliance with all cGMP regulations as well as other areas of mandatory regulatory oversight. Participates in and provides SME resources to support all regulatory audits and technical discussions. Real time, on the floor, Batch Production Record review. Qualifications for the Manufacturing Manager include Bachelor's or Master's Degree in a scientificengineering discipline or equivalent related experience in cGMP biologicspharmaceutical manufacturing Minimum of 5- 7 years of cGMP bio-pharmaceutical experience with a minimum of 2 years of supervisiondemonstrated leadership Knowledge of cGMP and CFR requirements Compensation for the Manufacturing Manager includes Salary Range 80,000-100,000 per hour Comprehensive Benefits Healthcare, Dental, Vision
    Posting ID: 600054083Posted: 2021-01-16