Sr. Process Development Engineer

AlkermesWaltham, MA
$140,000 - $154,000

About The Position

Join the Alkermes Process Development team as Senior Engineer, where you will provide technical leadership and support the development of innovative small molecule pharmaceutical dosage forms. You will operate within cross functional teams to ensure alignment during drug product development, join the CMC teams, and provide leadership for development teams. You will design and execute experimental studies to develop well understood, robust oral solid dosage manufacturing processes. Key duties are process design, equipment set-up, troubleshooting equipment, running experiments, collecting/evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability. This position requires experience in oral solid dosage processing techniques used for manufacture of dosage forms (such as milling, blending, wet and dry granulation, compression, encapsulation and coating). You will also lead process development activities and clinical manufacturing in a GMP facility for oral solid dosage forms, maintaining GMP standards.

Requirements

  • Experience in oral solid dosage processing techniques used for manufacture of dosage forms (such as milling, blending, wet and dry granulation, compression, encapsulation and coating).
  • Experience maintaining GMP standards.

Responsibilities

  • Provide technical leadership and support the development of innovative small molecule pharmaceutical dosage forms.
  • Operate within cross functional teams to ensure alignment during drug product development.
  • Join the CMC teams.
  • Provide leadership for development teams.
  • Design and execute experimental studies to develop well understood, robust oral solid dosage manufacturing processes.
  • Process design.
  • Equipment set-up.
  • Troubleshooting equipment.
  • Running experiments.
  • Collecting/evaluating data to identify and implement process/equipment improvements reducing waste and increasing process reliability.
  • Lead process development activities and clinical manufacturing in a GMP facility for oral solid dosage forms, maintaining GMP standards.
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