Process Development Scientist

Posting Date 3 months ago(6/30/2020 9:46 AM)
Requisition ID
2020-7660
Job Location(s)
Pittsburgh PA United States
Travel
Less than 10%
Position Type
Full Time
Company
Cook Myosite Inc.
Category
Scientific

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 Process Development Scientist at Cook Myosite Inc. will be responsible for supporting the development of manufacturing processes for cellular therapy products treating a range of muscle-based conditions and diseases.  This is a predominantly laboratory based role, with expectations to perform experimental work in accordance with industry best practices and external regulatory requirements for GMP. 

 

Responsibilities

• Assist in all areas of manufacturing process development, including discovery, design, development, characterization, transfer, validation, and lifecycle management, with a focus on materials used in the manufacturing process
• Work with department management to identify and develop project objectives and timelines

• Act as a departmental and cross-functional subject matter expert to provide technical and scientific support regarding material control systems and other areas of expertise
• Plan and execute laboratory-based experimentation in support of new and ongoing process development projects

• Perform research, analyze and summarize data, participate in the interpretation of results and formulation of recommendations
• Evaluate and optimize cell culture-based processing methods, and related materials, equipment, and technology   
• Effectively track and communicate project progress with stakeholders
• Prepare technical and scientifically accurate reports and presentations for internal and external use

• Assist in preparation and review of process design documentation and related regulatory documentation
• Assist in internal and external technical transfer of manufacturing processes, including development and support of manufacturing operations

• Develop scientific and technical proficiency and capabilities as necessary for project completion
• Support routine maintenance of cell cultures, laboratory space, inventory, and equipment

Qualifications

• Undergraduate degree in Life Sciences or Engineering and/or related research experience; advanced degree preferred

• Extensive experience with cell and tissue culture and/or relevant technical areas

• Experience with cGMP and related regulations associated with biologic/pharmaceutical product manufacturing and/or regenerative medicine

• Knowledge of GMP material control systems (e.g. 21 CFR 211 Subpart E, USP <1043>)
• Ongoing commitment to expanding knowledge, job skills, and abilities
• Ability to work collaboratively while independently executing projects
• Excellent problem-solving skills

• Ability to think critically and exercise sound judgment in conducting and interpreting scientific research

• Ability to effectively collaborate and communicate with other departments and cross-functional teams

• Effective technical writing skills

• Effective interpersonal skills and ability to lead departmental project teams

 

Physical Requirements

• Lab / Non-Production Setting

• 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.

• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting.

• 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) and facial mask (if required) on a regular basis.

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

 

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