Job Description

Scientist II, Analytical Development

Summary:

Provide critical cellular therapy/regenerative medicine assay expertise to advance the development the company’s cellular therapy assay portfolio, which includes testing for viability, purity, potency, safety, and cell characterization. Responsible to manage, supervise and coordinate all scientific activities for company pertaining to cellular therapy/regenerative medicine product testing, including, new product or service development, qualification, validation, technical transfer, implementation, and training of Laboratory personnel on assays and relevant processes.

Duties and Responsibilities:

• Implementation and continuous improvement of cellular therapy/regenerative medicine product assays, which include, but are not limited to the following test methodologies: multi‐color/multi‐parameter flow cytometry, PCR, endotoxin, multiplex ELISA, bioassay, and potency assays.
• Serve as a leader as well as work collaboratively with other scientists and technologists on projects in a cross‐functional team setting and act as a champion for cellular therapy assay product line.
• Act as a liaison and forge collaborative relationships with internal and clients, staff, suppliers, strategic partners, and regulatory/accreditation agencies.
• Provide guidance to team-oriented work projects, and participate in the development and implementation of strategic initiatives.
• Independently design, execute, and interpret results for laboratory experiments/validation studies to evaluate and/or validate laboratory processes and test methods, which may involve the implementation of highly complex testing machinery or manual testing skills.
• Provide knowledge and expertise on relevant scientific principles, which may require authoring SOPs, supporting departmental training/competency assessment activities, participating in audits, and serving as a department liaison, as required.
• Maintain adherence and assist with the development of project plans and budgets.
• Establish operating parameters and quality control limits as required.
• Assisting with the resolution of quality improvement investigations/CAPA implementation, equipment malfunctions and other technical problems.
• Maintain strict adherence to Standard Operating Procedures (SOPs).
• Prepare and maintain reports/records and perform computer data entry.
• Performs other duties as assigned.

Education:

• Requires a master’s degree from an accredited college or university in a specialized area, with no option for degree in related field or equivalent experience. The required major is Cellular Biology, Molecular Biology, Biochemistry, Cellular Engineering,
• Doctoral Degree (Ph.D. from an accredited college or university.) a plus

Licenses and/or Certifications

• Valid United States Driver’s License
• US Passport preferred
• Related Professional certifications preferred

Experience:

• Requires five or more years of job specific experience in regenerative medicine/cellular therapy testing, preferably in a cGMP and FDA regulated or clinical laboratory setting.
• Requires the following technical skills/experience: aseptic technique, mammalian cell culture, flow cytometry, qPCR, multiplex ELISA, bioassay, potency assay, and microscopy.

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