Production Manager

Posting Date 2 months ago(8/5/2020 8:48 PM)
Requisition ID
2020-7593
Job Location(s)
Pittsburgh PA United States
Travel
None
Shift Type
Some Weekends required
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 Production Manager at Cook MyoSite will oversee all aspects of manufacturing products which meet company standards, operating procedures, and Quality System standards and requirements. In addition, the Production Manager will deliver results and attain production schedules and output targets without defect or deviation.

Responsibilities

• Responsible for the production operations associated with the manufacture of all GMP products and Laboratory Research Products (LRP)
• Oversees production areas, schedules, materials, equipment and manpower requirements
• Develops interim goals and schedules for staff and manages production through shift or unit supervisors
• Oversees progress of supervisors’ daily schedules to ensure safe and timely completion of releasable products
• Ensures plans and resources are efficiently utilized to maintain uninterrupted supply of products
• Ensure functional unit’s compliance with company quality system and cGMP and all its related elements, such as facilities, documentation, training, reports and records
• Ensures timely review of Production Batch Records and associated documentation
• Oversees product or process-related investigations

• Participates in the hiring, development, retention and optimal performance of staff for the leadership and execution of manufacturing operations
• Monitors achievement of short and long-term production goals
• Point person for technical and compliance issues and liaisons with internal groups (QA, QC, Regulatory etc.) to facilitate issue resolution
• Other areas of responsibility include ensuring the proper maintenance of equipment/components and work areas for work tasks, and proper sanitization of all production areas and maintaining knowledge of manufacturing procedures and federal and international regulations pertaining to manufacturing processes

Qualifications

• Undergraduate degree in any life science or engineering field or 6 years direct, relevant experience in the management of manufacturing operations in a regulated industry

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

• Basic understanding of cGMPs, 21 CFR 210 and 211, and Part 11.  Application of regulations associated with Bio/Pharmaceutical product manufacturing

• Minimum experience preferred includes 6 years' in a biologics /medical device / biopharmaceutical manufacturing environment including previous experience managing up to 10+ direct reports / 20+ indirect reports

• Knowledge and application of industry standards and guidelines/regulations related to the manufacturing of sterile injectable drug and biologic products (21 CFR 210 and 211) and cGMPs

 

Physical Requirements:

• Laboratory / Manufacturing Plant Setting (Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals with proper PPE 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 on a regular basis and periodically for up to 3 hours at time.

• A minimum of 20/20 vision with or without correction with both eyes on the Pocket Vision Screener from 14 inches.  A minimum of 20/20 vision with or without correction in both eyes on Graham Field Eye test chart from 10 feet. Must be able to identify colors on the Ishihara Charts of Color Deficiency.

• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.

• Must be able to maintain manual acuity for working with computers and equipment.  Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.

• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.

• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) hood, facial mask and appropriate shoes required on a regular basis.

• Must be capable of performing PPE gowning procedures, aseptically for up to 5 hours at a minimum of one time per year.

• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.

• Must be able to maintain focus, aseptic qualifications and performance standards of position for extended periods of time without rest periods; periodically at intervals for up to 5 hours at a time.

 

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