Alkermes · 4 hours ago
Process Development Technician
Waltham, MA, United States
Full-time
Onsite
Entry Level
1+ years expAlkermes is a global biopharmaceutical company focused on developing medicines for psychiatric and neurological disorders. The Process Development Technician role involves supporting the execution of experimental studies to develop robust oral solid dosage manufacturing processes, ensuring compliance with GMP standards, and maintaining equipment and documentation.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Support the set up and operation of a new GMP clinical manufacturing suite with a broad range of processing capability and technology approaches
Operate, maintain, and troubleshoot a variety of process equipment, rapidly assimilating and applying new technologies as introduced
Perform equipment and room cleaning in compliance with established housekeeping and GMP standards
Assist in designing experimental programs and compiling data from studies
Execute experiments to enhance process understanding and manufacture GMP clinical batches at various scales
Complete all documentation accurately and legibly, ensuring compliance, and participate in updating batch paperwork and SOPs
Maintain a working knowledge of Manufacturing, Quality, and Development systems and procedures; support regulatory inspections and audits as required
Maintain awareness of project schedules and strive to achieve whilst responding positively and flexibly to changing priorities to ensure desired outcomes
Assist with root cause investigations and the implementation of CAPAs, as appropriate
Ensure compliance with all applicable cGMP, safety, environmental regulations, and company policies
Take ownership of the general upkeep of process areas and ensure project goals are met
Perform other duties as assigned
Qualification
Required
Associate's degree in engineering/scientific discipline, or equivalent, with 1-3+ years of experience in pharmaceutical solid oral dosage processing
Strong understanding of mechanical and chemical engineering principles as applied to general process systems and oral solid dosage equipment
Demonstrated hands-on ability to install, operate, and troubleshoot process equipment and instrumentation
Proficiency with solid oral dosage processing techniques, including powder blending, granulation, compression, coating, and encapsulation
Working knowledge of data analysis techniques used in process development studies
Technical problem-solving ability utilizing current research and technologies
Understanding of the drug development process and the role and impact of process development within this process
Demonstrated strong people skills, and excellent verbal and written communication skills
Understanding of ICH, FDA, and USP guidelines and the ability to apply these guidelines in context of the stage of drug development
Demonstrated ability to work successfully in a fast-paced team/matrix environment as well as independently manage priorities and maintain timelines for multiple activities
Company
Alkermes
Alkermes is a biotechnology company that develops, manufactures and commercializes medicines for the treatment of chronic diseases.
1001-5000 employees
H1B Sponsorship
Alkermes has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (20)
2023 (21)
2022 (14)
2021 (27)
2020 (22)
Funding
Current Stage
Public CompanyTotal Funding
$250MKey Investors
Primecap Management
2017-11-20Post Ipo Equity
2014-01-13Post Ipo Equity· $250M
2011-09-16IPO
Leadership Team
Craig Hopkinson
EVP, Research and Development, CMO
Recent News
2026-01-13
2026-01-09
Company data provided by crunchbase