Process Development Scientist II

Process Development Scientist II 

Primary Function
Designs and executes technical and scientific work to support process development for cell therapy clinical and research products. 
 
Essential Job Functions/Duties
Perform research, analyze, and summarize data, participate in the interpretation of results and formulation of recommendations  
Lead projects in all areas of manufacturing process development, including discovery, design, development, characterization, transfer, validation, and lifecycle management  
Plan and execute laboratory-based experimentation in support of new and ongoing process development projects  
Act as a departmental and cross-functional subject matter expert to provide technical and scientific support in areas of expertise  
Prepare technical and scientifically accurate reports and presentations for internal and external use 
Assist in internal and external technical transfer of manufacturing processes, including development and support of manufacturing operations  
Summarize results and present data to technical audiences 
Assist in preparation and review of process design documentation and related regulatory documentation 
Conduct technical review of departmental reports  
Evaluate and optimize cell culture-based processing methods, and related materials, equipment, and technology  
Work with department management to identify and develop project objectives and timelines 
Effectively track and communicate project progress with stakeholders
Serve as subject matter expert during GMP investigations, as appropriate  
Help coordinate and influence departmental projects to support alignment with overarching objectives and priorities 
Support routine maintenance of cell cultures, laboratory space, inventory, and equipment 

Knowledge, Skills, and Abilities
General Skills & Abilities
Broad knowledge of, and skills required to maintain company quality and safety standards.
Operates independently on most matters.
Completes assigned projects to develop scientific and technical proficiency.
Developed problem solving, analytical and critical thinking skills applicable to areas of responsibility.
Developed presentation skills to create and impart to others, findings and results that are complex in nature.
Developed reading and writing skills to conduct research, organize findings and report results in concise, understandable manner.
Ability to work individually and within a team. 
Ability to meet deadlines while working on multiple projects.
Ability to understand and demonstrate Cook MyoSite Core Values. 
Ability to maintain regular and punctual attendance.
Ability and desire to enhance knowledge, skills and abilities through training, research and on-the-job experiences as needed to maintain competency in job performance. 
Ability to work effectively and professionally with and for others at various levels of global organization to achieve company goals.
Proficient knowledge of Microsoft Office software, and other general office equipment. 
Proficiency or comfort level working with material of a highly technical or scientific nature. 

Education/Qualification Requirements
Undergraduate degree in Life Sciences or Engineering
Experience Preferred: 
Doctoral degree with 0-1 years of relevant research experience
Master’s degree with at least 3 years of relevant research experience
Undergraduate degree with at least 5 years of relevant research experience
Preferred Qualifications:
Must have experience with cell and tissue culture and/or relevant technical areas 
Must have a general understanding of statistical analyses 
Preferred experience in process and/or product development  
Preferred knowledge of cGMP and related regulations associated with biologic/pharmaceutical product manufacturing
 
Physical Requirements/Work Environment
HYBRID

Laboratory Setting (Non-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. 
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. 

Permanent Resident / Citizen Only 

Employee that does not interact with Healthcare Professionals
Compliance with all policies of the company including without limitation the Cook Employee Manual, Cook Code of Conduct, Quality System Manual, Cook Electronic Information Policy and HIPAA regulations.

At Cook MyoSite, we don’t just accept difference — we celebrate it, we support it, and we thrive on it for the benefit of our employees, our products, and our community. Cook MyoSite is proud to be an equal opportunity workplace.
This job description features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or responsibilities. This may be subject to change at any time due to reasonable accommodation or other reasons.