Scientist II, Analytical Development

Cellipont BioservicesThe Woodlands, TX
1d

About The Position

Cellipont Bioservices is growing, and we are looking for a Scientist II, Analytical Development who believe in the potential bridging clients discoveries to patient cures and who want to challenge the status quo and take Cellipont and it's clients to the next level. The Scientist II, Analytical Development will participate in activities of development, tech transfer, qualification, validation, and automation of analytical methods to support client product manufacturing activities. This position plays a key role demonstrating the values, culture, and deliverables for the site.

Requirements

  • 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.
  • 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.
  • D. preferred with a minimum of 1+ 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.

Nice To Haves

  • Experience in operating automated laboratory equipment is preferred.

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.

Benefits

  • Opportunities for career growth within an expanding team.
  • Defined career path and annual performance review & feedback process.
  • Cross-functional exposure to other areas of within the organization.
  • Robust benefit package designed for unique Health & Wellness needs, including coverage for your furry family members.
  • 401K strong employer match.
  • Tuition Reimbursement.
  • Employee Referral Bonuses.
  • Flexible work schedules and PTO based on role/level, increasing 1 PTO day each year and paid holidays
  • Gain experience in the cutting-edge cell therapy space
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