• location: Collegeville, PA
  • type: Contract
  • salary: $32.75 - $38.53 per hour

job description

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Job Title: Pharmaceutical Scientist

Job Summary

  • Provide scientific support for pilot plant facilities and project teams to ensure data meet compendial and quality standards.

Job Responsibilities

  • Co-ordinate or perform appropriate scientific testing (including CCI) to support release of finished products or testing of stability samples for clinical product manufacture.
  • Review microbiological test results from in house or contract microbiological testing labs for completeness, accuracy, and quality, in addition to assessing trends to draw conclusions.
  • Work with UP microbiology team to define microbiological control strategies for drug products (both API and Formulations).
  • Provide CMC regulatory submission support with respect to microbiology for milestone studies.
  • Maintain partnership with clinical manufacturing and product development teams to provide timely and high quality data and service.
  • Develop and propose specifications, sampling instructions, test methods and other Quality Control procedures.
  • Maintain training records and familiarity with current SOPs and controlled documents
  • Proactively seek assistance from other scientists to solve problems.
  • Work to GMP standards as appropriate.
  • Follow safe Laboratory Practices, regular safety training, and maintain accurate and complete safety records consistent with company policy and legal requirements.

Education & Qualifications

  • Bachelor's degree in a scientific or technical discipline (i.e. Pharmaceutical Sciences, Microbiology, Biology) with preference to having pharmaceutical experience in method development, validation and testing of API/drug products.
  • General compendial knowledge of USP Microbiology.
  • Experience with GMP laboratory operations and FDA regulations
  • Excellent verbal and written communication skills.
  • Ability to prioritize and organize tasks.


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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