Lead Small‑Molecule Process Development Engineer

Alkermes; Waltham (MA); Vor Ort; USD 173.000 - 193.000; Vollzeit

Zusammenfassung

Alkermes, a global biopharmaceutical company with a focus on neuroscience, seeks a Principal Engineer to lead late-stage drug product Process Development. You will guide experiments, scale-up, and tech transfer to manufacturing sites from Phase 3 to PPQ, and collaborate with the CMC and Operations teams to drive critical decisions.

You will mentor junior staff, apply ICH/FDA guidelines, and ensure robust development programs across multiple projects in a fast-paced matrix environment.

Qualifikationen

• PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering.
• Expertise in small molecule process development, scale up and technical transfer.
• Design of experiments, data analysis and data interpretation for process development studies.
• Experience managing contract drug development (CDMO) activities.
• Technical problem-solving ability utilizing current research and technologies.
• Broad understanding of the drug development process and the role of process development.
• Demonstrated collaborative leadership, strong people skills, and excellent verbal and written communication skills.
• Expert understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development.
• Proficiency across processing techniques such as powder blending, granulation, compression, encapsulation, Wurster coating and pan coating.
• Ability to work in fast-paced team/matrix environments and independently manage priorities.

Aufgaben

• Provide subject matter expertise in process development methodologies with internal/external execution and supervision.
• Guide and drive process development, DOE, product characterization and control strategy development for development programs.
• Design and execute process development activities suitable for progressive stages of small molecule development following ICH and FDA guidance.
• Collaborate with Pharmaceutical Development and Manufacturing to leverage capabilities for process development.
• Provide timely technical support and management oversight of process development at external partners.
• Develop, review, and approve process development source documents and regulatory submissions sections.
• Present technical data to cross-functional teams and senior management as a process development expert.
• Identify and advocate new technology opportunities for process development.
• Manage, train and mentor junior Process Development staff.
• Perform other duties as assigned.

Kenntnisse

Small molecule PD

DOE

Data analysis

Tech transfer

Cross-functional leadership

Regulatory guidance

Process development

Problem solving

Communication

Ausbildung

PhD (>8 years) or MS (>15 years) in Science or Engineering

Tools

Process Analytical Technology

Jobbeschreibung

Alkermes, a global biopharmaceutical company with a focus on neuroscience, seeks a Principal Engineer to lead late-stage drug product Process Development. You will guide experiments, scale-up, and tech transfer to manufacturing sites from Phase 3 to PPQ, and collaborate with the CMC and Operations teams to drive critical decisions.

You will mentor junior staff, apply ICH/FDA guidelines, and ensure robust development programs across multiple projects in a fast-paced matrix environment.