Analytical Method Development Scientist II - Cook Group

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 II designs and executes technical and scientific work to support analytical method development for cell therapy clinical and research products.

Responsibilities

• Develop and optimize analytical methods for release or characterization of cell therapy products and associated materials• Perform research, analyze, and summarize data, participate in the interpretation of results and formulation of recommendations• Lead projects in all areas of analytical method development, including discovery, design, development, transfer, qualification, validation, and lifecycle management • Plan and execute laboratory-based experimentation in support of new and ongoing analytical method 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 validation and/or technical transfer of analytical methods, including development and support of QC laboratory operations • Summarize results and present data to technical audiences• Assist in preparation and review of method development history, product characterization, and related regulatory documentation • Conduct technical review of departmental reports • Evaluate and optimize analytical methods, and related reagents and instruments, for assessing manufacturing processes, materials, and products • 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

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 skills in applying statistical analyses and methods to product and analytical development.• 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.• Ability to anticipate material shortages and act proactively to avoid them.

Qualifications

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.

Undergraduate degree in Life Sciences or Engineering

Hybrid

Experience Preferred

Doctoral degree with 0-1 years of relevant research experienceMaster’s degree with at least 3 years of relevant research experienceUndergraduate degree with at least 5 years of relevant research experience

Preferred Qualifications

• Must have experience with relevant laboratory techniques for cell characterization, material testing, pharmacopeia testing, and/or relevant technical areas • Must have a general understanding of statistical analyses• Preferred experience in analytical method and/or product development • Preferred knowledge and experience in in-vitro techniques such as cellular assays, qPCR, Flow Cytometry, electrophoresis, and ELISA• Preferred knowledge of cGMP and related regulations associated with biologic/pharmaceutical product manufacturing

Physical Requirements

• 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.

Employee that does not interact with Healthcare ProfessionalsCompliance 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.