Laboratory Manufacturing Associate

Posting Date 4 months ago(6/2/2021 1:58 PM)
Requisition ID
2021-9091
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 Laboratory Manufacturing Associate at Cook MyoSite is responsible for manufacturing cellular products which meet company Quality System standards, standard operating procedures, and regulatory requirements.

Responsibilities

• Performs daily work with strict adherence to cGMPs, the company Quality System, and safety standards
• Ability to obtain and maintain required internal company qualifications, including but not limited to; gowning qualification, aseptic qualification
• Follows proper cleanroom behavior and aseptic practices while working inside the manufacturing suite and cleanroom environments
• Performs preparation of media, bulk solutions, filling and labeling of vials under sterile conditions
• Performs dissociation of human tissue to establish cell cultures
• Performs routine cell culture maintenance (media changes and passages)
• Performs terminal cell culture harvesting, formulation, and filling for releasable products
• Performs collection and submission of product generated and environmental monitoring samples
• Documents, and reviews, required information in Production batch records and associated forms in a timely fashion
• Initiates and authors quality system records (i.e. investigations)
• Operates routine laboratory equipment, including but not limited to; Incubators, centrifuges, balances, BSHs, -20°C/-80°C freezers, liquid nitrogen storage units

• Performs troubleshooting, bringing potential investigations to the attention of the Supervisor
• Maintains regular and punctual attendance
• Availability to work required shifts, which may include; weekends or weekdays, extended hours, and holidays

• Performs established cell count and viability assays using a flow cytometer
• Performs routine daily culture monitoring of products; both manually, and using an automated system

• Performs the quarantine and storage of manufactured products
• Assists with routine sanitizations of laboratories and the manufacturing suite with required use of half-faced respirator and/or PAPR along with additional PPE
• Assists with routine sanitization of manufacturing laboratory equipment in accordance with set procedures
• Assists with inventory management, and ordering, to maintain an adequate supply of resources for manufacturing of products
• Collects and properly dispose of biohazard waste
• Performs established processing area preparation and change over procedures for product interventions, routine sanitization of BSHs, and product lot clearance
• Assists department in improving/optimizing manufacturing processes
• Assists in training new personnel

 

Qualifications

• Bachelor's degree in any Life Science or Engineering field or 6 years direct, relevant experience in a laboratory environment to provide a comparable background
• Ability to successfully complete Production Associate training program

• Critical thinking and organizational skills
• Excellent oral and written communication skills
• Must work and interact effectively and professionally with others
• Excellent problem-solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision

 

Physical Requirements:

• 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 5.5 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 5.5 hours at a time.

• Potential limited exposure to hazardous chemicals and/or harsh disinfectants while in and out of BioSafety Level II

• Must be able to work extended hours beyond normal work schedule to include, but not limited to; evenings, weekends, holidays, 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.

 

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