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Company Contact Info
- Coram, NY
- Sharon Hedlund
- Phone: 631-259-4082
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Engage Partners, Inc. • Coram, NY
Posted 17 days ago
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The Manager of manufacturing will be responsible for managing and leading the daytoday operations for the commercial aseptic manufacturing of drug and device products. The position scope can include any arrangement of the following departments: Compounding, Equipment/ Component Preparation, Sterile Filling, Inspection and Packaging.
Drives operational excellence with regard formulation, Equipment / Component Preparation, Cleaning and Setup activities to support filling.
Drives operational excellence in accordance with short and longterm organizational objectives and strategic focus through leadership & technical expertise for continuous development of people & team, quality expectations, compliance, safety, customer and financial goals. Provides leadership and technical guidance for all manufacturing personnel in order to foster a healthy environment and culture that is collaborative, innovative and which promotes operational excellence.
Strategic Focus & Specific Tactical Responsibilities People / Team Development
Responsible for providing key leadership, communication, and organizational management of both nonexempt & exempt personnel including, process supervisors.
Responsible for the hiring, development and coaching of employees in order to ensure optimal level of performance by all manufacturing personnel.
Ensure that prospective candidates, who are hired into the business, align with the strategic direction of the manufacturing organization and to help foster a learning organization that exhibits leadership, personal accountability, and a strong sense of purpose and urgency. Commit to employee feedback and developmental processes through a communication plan, mentoring, technical acumen, and leadership development.
Foster a culture of continuous improvement through employee selection, training and mentoring whilst focusing on operational efficiency and the elimination of “nonvalue added" activities.
Support plantwide strategic plans, programs and activities.
Work collaboratively with inter department and crossfunctional teams and to act as a change agent whilst leading in a timely and productive manner.
Identify and follow up/lead opportunities that contribute to the improvement of current manufacturing processes and practices. Manage and lead the daily manufacturing operations across a single or multiple value streams.
Quality, Compliance & Safety
Responsible for assuring compliances with all regulatory requirements – FDA, OSHA, OFCCP, EPA, etc.
Adheres to all environmental, health and safety SOPs, equipment, policies and procedures, including any departmentspecific requirements.
Ensures adherence to production schedules, while holding Supervisors and teams responsible for compliance with all safety and quality regulations. Ensuring that appropriate levels of trained resources are available to meet scheduled attainment objectives.
Ensuring inspection readiness of all manufacturing areas.
Participates in inspections conducted by external / internal regulators and ensures the success of departmental audits. Interfaces directly with customers and regulatory personnel during plant audits and inspections.
Is responsible for “ontime" completion of investigations, CAPA’s for major and critical deviations and QE’s. Reviews and approves Quality Reports, validation protocols and reports.
Manages Change Controls
Complies with requirements from Safety Program, including Health and Safety mandates and OSHA requirements. Ensures the accuracy of all manufacturing management tools/systems and documentation (eg. SOP’s, OJT’s).
Partners with Manufacturing Engineering/Product Manager in order to troubleshoot and foster the resolution of process issues.
Continuously and proactively driving projects to improve manufacturing processes.
Ensures consistency in the adherence of personnel policy administration including attendance control and Disciplinary Policy.
Ensures timely deliverance of products to internal & external customers so that product quality, yield, operating costs and process efficiencies/expectations are satisfied.
Interfaces with the other managers/customers to ensure our quality commitments are satisfied.
Participates/leads the scheduling of projects and staff meetings in conjunction with providing updates on departmental activities and project statuses.
Ensures timely escalation of manufacturing issue(s) related to management and other crossfunctional support teams as may be necessary.
Advises senior management on production issues and vulnerabilities. Develop proposals for improvement and risk mitigation.
Ensures profitability [EBITDA] by challenging the status quo and striving for operational excellence for 1st time right product lots/Batch Records, utilization of labor thereby increasing acceptable units and finished good yields, throughput and Overall Equipment Effectiveness [OEE].
Increase efficiency and profitability through the minimization of production downtime, WIP Inventory, manufacturing cycle time and “setup" reduction.
Optimize resources within assigned areas in order to adhere to compliance standards and cost discipline.
The Manager of Manufacturing will be responsible for the manufacture and delivery of drug products that meets internal and external customer expectations. This job requires leadership, interpersonal, organizational and teambuilding skills.
Erroneous or mistimed decisions may result in critical delays thereby negatively impacting cost and may have an immediate effect on the company’s success.
Responsible for the supervisors, in the manufacturing of all commercial filled products that are aseptically and terminally sterilized.
Bachelor’s degree in a Science or Arts or Industry Related Experience
Minimum of 5 years of experience in aseptic manufacturing, pharmaceutical or medical industry and with a progressive experience leading to a management position.
Minimum of 3 years supervisory experience in a regulated industry is preferred.
Candidates should have a thorough knowledge of applied pharmaceutical and/or medical device including cGMPs in a commercial manufacturing environment.
Excellent verbal and written communication skills
Ability to work autonomously, manages time effectively and deliver results in a timely manner.