Plant Manager

Posting Date 2 months ago(12/2/2021 11:37 AM)
Requisition ID
2021-9969
Job Location(s)
Pittsburgh PA United States
Travel
None
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Production/MFG/Operations

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

 

The Plant Manager at Cook MyoSite Inc. is responsible for the day to day operations of the Cook MyoSite manufacturing plant and for carrying out the execution of the manufacturing schedule. The role provides daily leadership to the company’s Production, Metrology, Maintenance, and Environmental Health and Safety. The Plant Manager is responsible for the fulfillment of GMP production orders, as well as other support functions in compliance with applicable GMP regulations.

Responsibilities

• Direct and manage manufacturing operations that include proper contingencies that will limit manufacturing disruptions and optimize production capacity.
• Lead manufacturing personnel and establish efficient shift scheduling.
• Work with Quality leadership to establish key metrics to monitor overall plant performance for production and quality standards.
• Efficiently utilize and manage plant assets through regular planned calibration and maintenance.
• Provide input to supply chain functional strategy.
• Direct Environmental Health and Safety personnel to implement and maintain a safety environment in compliance with applicable Occupation Safety and Health Administration (OSHA) regulations.
• Develop and control plans and budget while implementing cost effective systems of control over capital, operating expenditures, manpower, wages and salaries.
• Incorporate facility organization and plant operational flow among personnel.
• Work with management to ensure that every step of the manufacturing process is followed meticulously and effectively.
• Work with business and clinical function leadership to create strategy for maximizing production, minimizing risk, and responding to market changes effectively and efficiently.
• Actively look for opportunities to improve quality.
• Provide tools and training necessary to make processes flow smoothly and effectively.
• Provide performance management and career development to direct staff.
• Identify potential problems and create solutions before they occur.
• Optimize processes and ensure sufficient controls and measures for process consistency.
• Facilitate cross-functional communication to enable adaptability between teams and departments.

Qualifications

• Undergraduate or master's degree in any Life Sciences or Business field is required

• Minimum of 10 years' experience in Biotechnology, Pharmaceutical, or Device industries is preferred

• Minimum of 10 years’ experience with exposure to cGMP environment is preferred
• Knowledge of FDA and foreign regulatory requirements as well as industry quality management tools, trends, practices, standards, and the quality system is preferred

• In-depth understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical manufacturing and best practices (e.g. ISPE GAMP)

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook

• Demonstrates strong interpersonal skills resulting in exceptional rapport with people. Proven success initiating, promoting and maintaining strong interpersonal relations

• Possesses the ability to develop and implement complex processes, procedures, and systems within and across functions.

• Must work and interact effectively and professionally with others

 

Physical Requirements:

• Laboratory Setting (Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.
• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.
• Ability to work under specific time constraints.
• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.
• Visual and manual acuity for working with computers and equipment.

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