Lead Principal Engineer, Small Molecule Process Development

Alkermes; Boston (MA); On-site; USD 173,000 - 193,000; Full time

Benefits offered by this job

Competitive benefits

Annual bonus

Career development

Job summary

Join the Alkermes Process Development team as a Principal Engineer, leading late-stage drug product process development at internal and external manufacturing sites. You will guide small molecule PD, scale-up and tech transfer from Phase 3 to PPQ, working with the CMC team and Operations in a collaborative matrix environment.

The role requires PhD or MS with extensive PD experience, DOE, data analysis, and strong communication. Competitive base salary in a global biopharma setting with benefits.

Qualifications

• PhD (>8 years’ experience) or MS (>15 years’ experience) in Science or Engineering.
• Expertise in small molecule process development, scale up and technical transfer.
• Expertise in 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 and impact 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.
• Subject matter proficiency across processing techniques such as powder blending, granulation, compression, encapsulation, Wurster coating and pan coating.
• Demonstrated ability to work in a fast-paced matrix environment as well as independently manage priorities and timelines.

Responsibilities

• Provide subject matter expertise in process development methodologies at Alkermes requiring internal/external execution and technical oversight/supervision.
• Guide and drive process development, design of experiments, product characterization and control strategy development for development programs.
• Design and execute process development activities suitable for progressive stages of small molecule pharmaceutical development that follow ICH and FDA guidance.
• Work closely with colleagues across Pharmaceutical Development and Manufacturing organizations to best leverage internal and/or external capabilities to assist in process development effort.
• Provide timely technical support and management oversight of process development activities at external partners.
• Develop, review, and approve process development source documents, and author and review drug product process development sections for regulatory submissions.
• Present technical data to cross functional teams and senior management as a process development expert, and effectively communicate critical process issues and solutions.
• Identify and advocate new and emerging technology opportunities for process development.
• Manage, train and mentor junior Process Development staff.
• Perform other duties as assigned.

Skills

Small molecule PD

Design of experiments

Technical transfer

CDMO management

Process characterization

Regulatory knowledge (ICH/FDA)

Leadership in matrix environments

Communication skills

Education

PhD in Science or Engineering

MS in Science or Engineering

Job description

Join the Alkermes Process Development team as a Principal Engineer, leading late-stage drug product process development at internal and external manufacturing sites. You will guide small molecule PD, scale-up and tech transfer from Phase 3 to PPQ, working with the CMC team and Operations in a collaborative matrix environment.

The role requires PhD or MS with extensive PD experience, DOE, data analysis, and strong communication. Competitive base salary in a global biopharma setting with benefits.