KBI Biopharma

KBI Biopharma

ELN Administrator

USA - NC - Durham - Hamlin Rd

Sponsorship not specified$84k-$116kDetected 14 days ago
ReactData AnalysisCustomer SupportGMPFDA RegulatoryAnimal StudiesCommunicationCollaborationProblem Solving

About the role

  • The ELN Administrator would provide timely end user support/guidance/assistance in the ELN system, as well as build, modify, and maintain templates and other user-managed information, conduct user training for the system, and provide basic troubleshooting.
  • Join a highly technical analytical team in a dynamic work environment as a member of the Analytical, Formulation and Stability (AFS) department and participate in contracted client analytical programs for monoclonal antibodies, recombinant proteins, and peptides as an Electronic Laboratory Notebook (ELN) Administrator.
  • Additionally, this position is a technical lead/subject-matter-expert for the ELN system, responsible for coordinating and collaborating with AFS department management, the ELN Product Owner, and IT on system improvement initiatives, system maintenance, as well as the implementation of system configuration updates and new releases.

Responsibilities

  • Provide technical and end user support to ensure efficient and trouble-free operation of the ELN system. Configure, deploy, and manage IDBS ELN templates and other user-managed information for efficient data recording and retrieval.
  • Lead and/or participate in system improvement initiatives.
  • Perform data analysis to extract meaningful insights from the ELN
  • Support client/regulatory audits as necessary.
  • Develop and maintain a current understanding of United States Food and Drug Administration (FDA) and European Medicines Agency (EMA) regulations as they pertain to computer system validation and compliance.
  • Strong collaboration and team building skills; strong communication and interpersonal skills
  • KBI supports its 500+ customers in advancing more than 160 drug candidates from preclinical and clinical stages to market, including the manufacture of ten commercial products.
  • Recognized for quality manufacturing, KBI delivers robust process development and cGMP manufacturing services across its six global locations in the USA and Europe.

Requirements

  • Bachelor's degree in computer science, pharmaceutical science, biology, chemistry, or other related science/IT.
  • Minimum of seven years of experience working in the pharmaceutical industry.
  • Must have experience working within an electronic laboratory notebook system in the pharmaceutical industry, preferably IDBS.
  • Knowledge and understanding of common analytical laboratory processes and assays (e.g., chromatography, rDNA, etc.), as well as quality control measures in the laboratory.
  • Experience in distilling complex procedures/assays into a standardized template.
  • Previous work in a regulated environment (FDA, EPA, etc.) is required.
  • Candidate must have:

Nice to have

  • Advanced proficiency in electronic laboratory notebook systems, IDBS preferred.

Compensation

  • Salary range provided per current averages and expectations.
  • The salary and job title for this opening will be based on the selected candidate's qualifications and experience and may be outside this range.
  • KBI has a robust total rewards strategy which includes an annual bonus structure for all employees, medical, dental, and vision coverage, paid PTO and holidays, Sabbatical program, 401K matching with 100% vesting in 60 days and employee recognition programs.
  • $84,000 - $115,500

Benefits

  • Therefore, all qualified applicants, regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability or veteran status, are strongly encouraged to apply.

Company info

  • At KBI Biopharma, we are advancing science and accelerating breakthroughs.
  • As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster.
  • Explore your potential at KBI, where innovation meets impact.
  • KBI Biopharma, Inc., a JSR Life Sciences company, is a global contract development and manufacturing organization (CDMO) providing fully integrated and accelerated drug development and biologics manufacturing services to life science companies.
  • For more information, visit www.kbibiopharma.com.
  • KBI is a proud EEO/AA employer dedicated to building a diverse and inclusive workforce.
  • We believe that innovation thrives in an environment where all voices are heard and valued.
  • That's why we actively seek individuals from all backgrounds - regardless of race, color, national origin, religion, gender, gender identity, sexual orientation, age, disability, or veteran status - and strongly encourage all qualified candidates to apply and bring their unique perspectives to our team.
  • KBI Biopharma, Inc. is an EEO/AA employer and actively seeks to diversify its work force.
  • I understand that neither the completion of this application nor any other part of my consideration for employment establishes any obligation for KBI Biopharma, Inc. to hire me.
  • If I am hired, I understand that either KBI Biopharma, Inc. or I can terminate my employment at any time and for any reason, with or without cause and without prior notice.
Apply directly at KBI Biopharma →Create a free account for alerts like thisView KBI Biopharma immigration profile

This listing is sourced directly from KBI Biopharma's careers page and normalized into a canonical job model.