2 land use associate jobs found

Alkermes, Inc. The primary responsibilities of an Associate Director in the Nonclinical Safety Evaluation (NSE) organization are to (1) design and implement nonclinical safety assessment strategies to support the nomination and development of Alkermes' diverse small molecule drug candidates and (2) communicate strategies and findings internally and to regulatory authorities globally. The Associate Director is the single point of accountability within NSE for all strategic, scientific, study-related, and regulatory aspects of the programs he/she manages. The Associate Director in NSE has a broad understanding of toxicology and regulatory requirements to progress candidates through clinical development and is recognized by internal peers for his/her scientific contributions and deliverables (within discipline) to Discovery and Development programs. The individual has specific expertise in one or more areas relevant to nonclinical safety evaluation, shows competency in all aspects,...

Alkermes, Inc. Position Summary: The Process Development Technician supports the execution of experimental studies to develop well-understood, robust oral solid dosage (OSD) manufacturing processes. Key responsibilities include equipment setup, cleaning, troubleshooting, execution of experiments, and data collection to identify and implement process and equipment improvements that reduce waste and increase process reliability. This role plays a key part in maintaining GMP standards within the pilot facility and supporting the manufacture of clinical supplies. 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...