Senior Manufacturing Manager

(5102) Genz. Therap Product LP
Framingham, MA Full Time
POSTED ON 5/18/2022 CLOSED ON 10/28/2022

Job Posting for Senior Manufacturing Manager at (5102) Genz. Therap Product LP

Position Summary The Manufacturing Manager is responsible for managing a manufacturing team and leading the manufacturing floor operations including execution to procedures and schedule, personnel training, and containment/escalation of issues and deviations both within manufacturing and to support functions. Core Responsibilities Personnel Management Maintains a safe working environment and reporting incidents/accidents to site leadership. Responsible for spear heading a streamlined door to floor process for onboarding contractors Develops system to ensure training of contractors is done using streamlined practices which result in fast access to systems as required. Ensures training is tracked to milestones and delays are understood and addressed. Managed a system to ensure contractors are being efficiently utilized within manufacturing and trained to meet critical needs. Schedules and/or delivers training to manufacturing personnel in accordance with Department Training Plan to ensure staff can perform manufacturing operations correctly, safely and compliantly. Manages all contractors and work with agency to address any performance issues. SMS Development Able to provide coaching/mentoring to L0 to align with APT priorities Able to create/increase knowledge of tools so they are providing added value to APT Able to provide coaching /mentoring during GEMBAs to ensure effective deviation initiation/process Development of utilization of expanded skills matrix tools and meeting structure to drive cross training Deviation Management Able to identify key levers to drive business outputs ie. (Deviation on time/CAPA on time) Able to create metric template that increases visibility to business data Able to work cross functionally to drive APT business objectives Supports Manufacturing Operations Manager and Manufacturing Specialist in the investigation, closure, and CAPA implementation for major and critical deviations. Continuous Improvement Contributes to continual improvement of all manufacturing documentation (SOP’s MBR’s, OJT’s) to ensure they are current, accurate, and clear. Review and refine the current document periodic review process to ensure that all manufacturing documents are accurate and revised as necessary. Manages or supporting plant floor continuous improvement initiatives thru either change control, CAPA and/or document update support. Represents Manufacturing in Project Team meetings; may lead department initiatives and projects. An ongoing commitment to conducting our global business according to the highest legal and ethical standards, and to continually pursue excellence in the development and delivery of all of our products and services. This includes: Adhering to all applicable laws and regulations of the places in which we conduct business, as well as our own Company policies and procedures. Being honest and treating people with respect and courtesy. Constantly striving to make Genzyme a great place to work, and a company respected for the quality of its people and products. Acting as role models for our fellow employees by acting responsibly, fairly, and honestly in our dealings and exercising sound judgment in performing our jobs. Leading People Genzyme's leaders motivate, inspire, build, and retain highly effective manufacturing teams while managing for high performance and developing others. They are versatile learners and courageous decision makers. Leading the Business Genzyme's leaders are effective operating in an evolving, complex and dynamic environment, providing clear direction and instruction to direct reports, and continuously looking internally and externally for best practices and areas for improvement. Delivering to Customers Genzyme's leaders understand patient and customer needs and build relationships as required to meet manufacturing goals while continuously improving operations by setting high standards for the team so they may perform to a level of excellence. Basic Qualifications: High School diploma/GED with 6-10 years of experience in a cGXP environment, or a Bachelor’s degree with 4-8 years of experience. 2-5 year in a supervisor role. Experience in QMS Must have prior experience in cGMP manufacturing operations. Demonstrated ability to effectively coach and train employees. Ability to lift up to 50lbs. Prefered Qualifications Bachelor’s degree with 5-9 years of experience in bulk biologics GMP manufacturing and 3 years of experience leading manufacturing teams. Extended experience in Equipment Preparation, Cell Culture and Purification Operations. Experience leading manufacturing teams to maintain adherence to a demanding production schedule. Experience authoring and reviewing standard operating procedures, on the job trainings, and other controlled documents. Familiarity with Automated Production Systems (i.e. Distributed Control System). Demonstrate good technical writing skills, strong troubleshooting skills, and be familiar with biologics regulations. At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.
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