Scientist, Product Development - Injectables

ANI Pharmaceuticals
  • Middleton, WI
  • Autofill and Review
3 days ago

Job Description

Position Summary

The Scientist, Product Development- Injectables designs and performs experiments, analyzes data, and supports formulation and analytical development activities for injectable pharmaceutical products. Working alongside experienced scientists and cross-functional partners, this position offers opportunities to build expertise in analytical techniques, FDA regulations, and the drug development process within a collaborative laboratory environment.

Key Responsibilities

  • Perform wet-bench chemistry experiments, including UV-Vis spectroscopy, pH and tonicity adjustments, controlled heating and cooling of volatile materials, formulation development, and other laboratory-scale drug product manufacturing operations.
  • Analyze samples using techniques such as HPLC, plate-based assays, gel electrophoresis, osmolality testing, western blotting, and in vitro release testing.
  • Support the development, optimization, and validation of HPLC and other analytical test methods.
  • Contribute to the design, development, and quality support of drug-device combination products.
  • Collaborate on analytical and development projects across the Product Development- Injectables team.
  • Maintain complete and accurate experimental documentation in laboratory notebooks.
  • Present data and development progress during department and cross-functional meetings.
  • Perform other duties as assigned.

Required Qualifications

  • Bachelor's degree in chemistry, pharmaceutical sciences, biochemistry, or a related discipline.
  • Hands-on laboratory experience.
  • One to three years of relevant laboratory experience.
  • Ability to apply scientific principles to laboratory experimentation and data interpretation.
  • Ability to take initiative, follow technical direction, and contribute to laboratory problem-solving.
  • Strong written and verbal communication skills, including the ability to present technical information clearly.
  • Familiarity with current Good Manufacturing Practice requirements and good documentation practices.
  • Ability to work independently and collaboratively within a small team in a fast-paced, deadline-driven environment.
  • A flexible, team-oriented, and open-minded approach to work.

Preferred Qualifications

  • Experience with one or more of the laboratory and analytical techniques described above.
  • Experience with analytical method development.

Work Environment and Physical Requirements

  • Manual dexterity sufficient to operate laboratory equipment, including pipettes and analytical microbalances.
  • Ability to lift up to 25 pounds.
  • Ability to work safely in a laboratory environment that includes hazardous and toxic chemicals.
  • Ability to wear required personal protective equipment when working with toxic or corrosive materials in liquid, solid, vapor, or airborne-particle form.

Schedule, Location, and Travel

  • This role is based in Middleton, WI and is expected to work primarily on-site. Minimal travel is required.

Numbers & Facts

LocationMiddleton, WI

Skills

  • Analysis Skillsunmatched
  • Analytical Developmentunmatched
  • Analytical Method Developmentunmatched
  • Assaysunmatched
  • Biochemistryunmatched
  • Biotech and Pharmaceuticalunmatched
  • Chemistryunmatched
  • Communication Skillsunmatched
  • Cross-Functionalunmatched
  • Current Good Manufacturing Practice (cGMP)unmatched
  • Data Analysisunmatched
  • Documentationunmatched
  • Drug Developmentunmatched
  • Drug Manufacturingunmatched
  • Drug Productsunmatched
  • Experiment Designunmatched
  • FDA Requirementsunmatched
  • GMP (Good Manufacturing Practices)unmatched
  • High Performance Liquid Chromatography (HPLC)unmatched
  • In Vitro Testingunmatched
  • Laboratoryunmatched
  • Laboratory Analysisunmatched
  • Laboratory Equipmentunmatched
  • Laboratory Notebookunmatched
  • Laboratory Techniquesunmatched
  • Lift/Move 25 Poundsunmatched
  • Maintenance - HVACunmatched
  • Manual Dexterityunmatched
  • Manufacturing Operationsunmatched
  • Manufacturing Requirementsunmatched
  • Osmolarityunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Product Developmentunmatched
  • Quality Assurance Methodologyunmatched
  • Scientific Principlesunmatched
  • Specimen Analysisunmatched
  • Team Playerunmatched
  • Technical Presentationunmatched
  • Time Managementunmatched
  • UV/VIS (Ultraviolet-Visible Spectroscopy)unmatched
  • Willing to Travelunmatched
  • Writing Skillsunmatched

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