Senior Manufacruting Manager (2nd Shift) in Melville, NY at Engage Partners, Inc.

Date Posted: 6/2/2020

Job Snapshot

  • Employee Type:
  • Location:
    Melville, NY
  • Job Type:
  • Experience:
    At least 7 year(s)
  • Date Posted:

Job Description

Leading pharmaceutical company located in Long Island, NY,  is seeking a Senior Manufacturing Manager for a 2nd shift position. Candidate must be experienced in the commercial aseptic manufacturing of drug and device products. Pharmaceutical industry experience is required, experience with injectables is a plus.

The Senior Manager will be responsible for managing and leading the day-to-day 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.

Strategic Focus
  • Drives operational excellence in accordance with short and long-term 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 non-exempt & 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.

Operational Excellence
  • Foster a culture of continuous improvement through employee selection, training and mentoring whilst focusing on operational efficiency and the elimination of 'non-value added' activities.
  • Support plant-wide strategic plans, programs and activities. 
  • Work collaboratively with inter- department and cross-functional 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 department-specific 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 'on-time' 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 by 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 cross-functional 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 'set-up' reduction. 
  • Optimize resources within assigned areas in order to adhere to compliance standards and cost discipline.

Job Complexity
  • The Senior 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 team-building 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.

Supervisory Responsibilities
  • Responsible for the managers and supervisors in the manufacturing of all commercial filled products that are aseptically and terminally sterilized.

Required Qualifications
  • Bachelor's degree in a Science or Arts or Industry Related Experience
    Minimum of 7 years of experience in aseptic manufacturing, pharmaceutical or medical industry and with a progressive experience leading to a management position.
  • Minimum of 5 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.

Ogranization Profile

Pharmaceutical company dedicated to the development and marketing of innovative, quality drugs and medical devices for healthcare professionals, clinics, and hospitals across the United States and Canada. Specialized in sterile injectables, bone regeneration materials for dental procedures, as well as innovative products for acute pain control and veterinary medicine use.