Skip to content

Job Openings


Ready to elevate your career in Scientific fields? Explore our job opportunities now and unlock a world of innovation and impact. From groundbreaking research to cutting-edge technology, the Scientific industry offers unparalleled opportunities for growth and fulfillment. Imagine contributing to life-changing discoveries, influencing society, and achieving job satisfaction like never before. Join us in shaping the future – check out our listings and step into a rewarding career in Scientific today.

QC Biochemistry Analyst

Pennington, NJ 08534

Posted: 04/19/2024 Employment Type: Contract Job Category: Scientific Job Number: 602252 Is job remote?: No Country: United States

Job Description

Perform QC biochemistry laboratory assay validation and transfer activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, company processes and procedures. 

Essential Functions of the job:
  • Perform QC biochemistry assay validation and transfer activities, including testing (e.g., DS, DP release and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
  • Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, testing record keeping, etc.
  • Manage inventory of reagents and supplies for the laboratory.
  • Lead investigations of OOS, discrepancies, errors, failures requiring documented review and action.
  • Participate in internal and external GMP audits where possible.
  • Lead method transfer and method validation activities, prepare protocols and reports.
  • Train other junior level analysts and new hires.              
  • Subject matter expert in one or more areas of required testing.
  • Undertake any other duties as required.

Education Required:

Minimum of 2+ years with a bachelor’s or above in Biochemistry, Molecular biology, Biology, or Biotechnology-related scientific discipline. 5+ years of experience preferred.

Core Competencies, Knowledge, and Skill Requirements
  • Working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
  • Serve as subject matter expert for residual DNA by qPCR, host cell protein ELISA, Residual Protein A ELISA, binding activity ELISA, Capillary Electrophoresis (CE), and capillary isoelectric focusing electrophoresis(cIEF), including qualification, assay validation and transfer activities.
  • Working knowledge with USP/EP and cGMP/EU GMP.
  • Familiar with instrument and equipment validation.
  • Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
  • Strong leadership/team management skills and experience.
  • Credible and confident communicator (written and verbal) at all levels.
  • Strong analytical and problem-solving ability.
  • Hands-on approach, with a ‘can do’ attitude.
  • Ability to prioritize, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
  • Self-motivated, with the ability to work proactively using own initiative.
  • Committed to learning and development.

Computer Skills:   
  • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint)

  • Must be willing to travel approximately 10%
  • Ability to work on a computer for extended periods of time
Apply Online

Send an email reminder to:

Share This Job:

Related Jobs:

Login to save this search and get notified of similar positions.

Although this hasn't been an issue at Planet Pharma, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Wordpress Social Share Plugin powered by Ultimatelysocial