Process Development Specialist

3 weeks ago

Waltham, Massachusetts, United States Alkermes Full time

Job Summary

We are seeking a highly skilled Process Development Specialist to join our team at Alkermes. As a key member of our process development team, you will be responsible for leading processing activities in our new development and clinical manufacturing facility for oral solid dosage forms.

Key Responsibilities

  • Design process development activities focused on developing well-understood, science-driven products and processes at all scales, resulting in robust and repeatable control.
  • Select appropriate parameters for prototype/finished dosage production to ensure product quality and reproducibility are achieved.
  • Prepare protocols, reports, and sections of regulatory submissions.
  • Maintain compliance with all aspects of cGMP, Safety, and Environmental legislation and Company policy, which impacts on day-to-day activities.
  • Present technical data to cross-functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
  • Manage, train, and mentor junior Process Development staff.

Requirements

  • Bachelor's Degree in engineering/scientific discipline, or the equivalent with 5+ years of experience in pharmaceutical solid oral dosage processing.
  • Thorough mechanical and chemical engineering knowledge as it applies to general process systems and equipment, as well as oral solid dosage drug process systems and equipment.
  • Subject matter proficiency across a range of processing techniques such as, powder blending, granulation, compression, and coating.
  • Demonstrated experience in small molecule process development, scale-up, and technical transfer.
  • Knowledge of design of experiments, data analysis, and data interpretation for process development studies.
  • Understanding of the drug development process and the role and impact of process development within this process.
  • Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.

About Alkermes

Alkermes applies its deep neuroscience expertise to develop medicines designed to help people living with complex and difficult-to-treat psychiatric and neurological disorders. As a fully-integrated, global biopharmaceutical company, headquartered in Ireland with U.S. locations in Massachusetts and Ohio, we are committed to pursuing great science, driven by deep compassion to make a real impact in the lives of patients.

We strive to ensure that all voices are respected and valued, recognizing that our diversity of thought, background, and perspective makes us stronger. Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any qualified applicant or employee because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression, and identity, disability, genetic information, veteran status, military status, application for military service, or any other characteristic protected by local, state, or federal law.

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