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Cellipont Bioservices · 1 month ago

Senior Scientist, Analytical Development

The Woodlands, TX

Full-time

Hybrid

Senior Level, Lead/Staff

10+ years exp

Cellipont Bioservices is growing, and they are seeking a Senior Scientist in Analytical Development who believes in the potential of bridging clients' discoveries to patient cures. The role involves developing and qualifying analytical methods to support cell therapy manufacturing activities and requires collaboration with various teams to ensure compliance with industry standards.

BiotechnologyHealth CareManufacturingTherapeutics

Responsibilities

Able to work semi-independently, planning, executing and analyzing experiments for multiple projects to support process development, product characterization, in-process monitoring, stability testing, and GMP manufacturing

Act as technical subject matter expert (SME) for the company, leading and participating in developing, transferring, and qualifying cell therapy methods, including flow cytometry, ELISA, q-PCR/ddPCR, and/or cell-based assays

Ability to apply problem-solving skills, work in a high-paced team environment, multitask activities, meet deadlines, and prioritize work on multiple projects

Work collaboratively with the Process Development and Quality Control team members in the execution, documentation, training and transfer of analytical methods

Writes and reviews Standard Operating Procedures (SOPs), test records, protocols, and associated reports as needed

Experience presenting technical project status and data-driven updates to internal teams and clients

Maintain current awareness of GMP/GLP/GDP, ICH, USP, and FDA guidelines, industry standards, and trends that apply to current and future Cell Therapy Development operations and products

Assess, support, and implement new analytical technologies and fill the technical gaps within Cellipont

Provides support in aspects of Laboratory Investigations, Deviations, CAPAs, Change Control, and Quality Records

Domestic or international travel maybe be required

Qualification

Analytical methods expertiseFlow cytometryELISAQ-PCR/ddPCRCell-based assaysGMP/GLP/GDP knowledgeProblem-solving skillsInterpersonal skillsPresentation skillsAttention to detail

Required

Bachelors Degree minimum in Biological Science, Biochemical Engineering, or related science preferred with a minimum of 10+ years of laboratory experience in R&D or Analytical Development within academia and/or direct industry environment

Demonstrated expertise in a range of analytical methods used in cell therapy, including flow cytometry, ELISA, q-PCR/ddPCR, and/or cell-based assays required

Attention to detail, problem-solving ability, and troubleshooting assays and instrumentation are required

Ability to effectively present information to top management, public groups, and/or clients

Excellent interpersonal skills with the ability to work individually and as part of a multifunctional team

Preferred

Masters Degree preferred with a minimum of 4+ years of laboratory experience in R&D or Analytical Development within academia and/or direct industry environment

Ph.D. preferred with a minimum of 2+ years of laboratory experience in R&D or Analytical Development within academia and/or direct industry environment