Analytical Method Development Scientist

Posting Date 2 weeks ago(9/16/2020 3:23 PM)
Requisition ID
2020-7846
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 Analytical Method Development Scientist at Cook Myosite Inc. is responsible for leading technical and scientific work to support analytical method development for cell therapy products and related research projects.

 

Responsibilities

• Assist in all areas of analytical method development, including discovery, design, development, transfer, qualification, validation, and lifecycle management

• Work with department management to identify and develop project objectives and timelines

• Help coordinate and influence departmental projects to support alignment with overarching objectives and priorities

• Plan and execute laboratory-based experimentation in support of new and ongoing analytical method development projects

• Perform research, analyze and summarize data, participate in the interpretation of results and formulation of recommendations

• Evaluate and optimize analytical methods, and related reagents and instruments, for assessing manufacturing processes, materials, and products

• Act as a departmental and cross-functional subject matter expert to provide technical and scientific support in areas of expertise

• 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 method development history, product characterization, and related regulatory documentation

• Conduct technical review of departmental reports

• Assist in internal and external technical transfer of analytical methods, including development and support of QC laboratory operations

• Support the design, planning, and execution of analytical method validation studies and related activities

• 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 required

• Advanced degree in Life Sciences or Engineering and/or related research experience preferred
• Experience in late phase biologic/drug development is preferred
• Knowledge of the regulatory environment, particularly guidelines on analytical method development and validation and application of compendial methods and standards
• Broad experience with cell-based assays
• Must be independent and able to proactively apply knowledge in the design, execution and qualification of analytical methodologies
• Ability to effectively document and communicate results

• Knowledge of cGMP and related regulations associated with biologic/pharmaceutical product manufacturing preferred

• Experience in analytical method and/or product development

• Extensive experience with relevant laboratory techniques for cell characterization, material testing, pharmacopeia testing, and/or relevant technical areas

 

Physical Requirements

• Lab / Non-Production Setting: 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.

• 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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