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Cellipont Bioservices · 2 weeks ago

Scientist II, Analytical Development

The Woodlands, TX

Full-time

Onsite

Mid, Senior Level

5+ years exp

Cellipont Bioservices is a growing company focused on developing and manufacturing cell therapies. The Scientist II, Analytical Development will play a key role in the development, tech transfer, and validation of analytical methods to support client product manufacturing activities.

BiotechnologyHealth CareManufacturingTherapeutics

Responsibilities

Ability to work semi-independently, 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

Co-lead the development of automated QC methods for high-throughput sample testing, including the preparation, purification, and nucleic acid amplification

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

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

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

Responsible for remaining current with 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, CAPAs, Change Control, and Quality Records

Domestic or international travel maybe be required

Qualification

Analytical methods expertiseFlow cytometryELISAQ-PCR/ddPCRCell-based assaysAutomated laboratory equipmentAttention to detailProblem-solving abilityInterpersonal skillsTeam collaboration

Required

Bachelor's Degree minimum in Biological Science, Biochemical Engineering, or related science preferred with a minimum of 5+ 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 apply problem-solving skills, work in a high-paced team environment, multitask activities, meet deadlines, and prioritize work on multiple projects

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

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

Ph.D. preferred with a minimum of 1+ years of laboratory experience in R&D or Analytical Development within academia and/or direct industry environment

Experience in operating automated laboratory equipment is preferred