The Biologics drug substance process development unit at Alkermes is responsible for the design and optimization of biologics manufacturing processes. This division encompasses cell line development, upstream (protein expression) and downstream (protein purification) process development. The primary focus of process development is to design, develop, optimize, scale up an

We are seeking an enthusiastic and highly motivated Scientist to join the Functional Genomics team in the Modeling and Informatics group within Alkermes R&D. Detail oriented and creative scientist with experience in NGS based genomics experiments and an aspiration to innovate using multi omic technologies to drive value for drug development programs. Work in an exciting i

As Manager, Regulatory Affairs CMC you will support planning, preparation, review, and submission of CMC sections and related content for global investigational new drug applications (IND/IMPD/CTA) and amendments, and global marketing applications (NDA/BLA/MAA), post approval supplements, and annual reports. You will work with your Regulatory CMC colleagues to ensure comp

Collaborate with stakeholders including senior regional leadership to develop and execute regional marketing initiatives Serve as field liaison to the brand teams, bringing insights from thought leaders and sales teams Develop regional KOL strategy by identifying, profiling and engaging rising Regional and National Thought Leaders across appropriate Psychiatry franchise d

The Manager Supply Chain Distribution & Logistics (3PL) , manages relationships with 3PL external suppliers, and internal stakeholders including; Commercial Supply Chain, Free Goods Teams, Legal, Quality, Finance, Procurement and Distribution and Logistics to manage supply related activities, ensuring that systems, policies and procedures are in place and effective to mee

Alkermes, Inc. is the U.S. operating company of Alkermes plc, a fully integrated, global biopharmaceutical company that applies its scientific expertise and proprietary technologies to research, develop and commercialize, both with partners and on its own, pharmaceutical products that are designed to address unmet medical needs of patients in major therapeutic areas. Alke

The Senior Director/Director level clinical pharmacologist in the Department of Translational Medicine and Early Stage Clinical Development plays a central role in both clinical development and in support of nonclinical development at Alkermes. He/she will represent Clinical Pharmacology function and provide subject matter expertise on cross functional project teams. Clin

Observe manufacturing operations in an aseptic environment. Review of manufacturing batch records, executed validation review, Maximo Work Orders and logbooks. Identify and communicate identified non conformances. Write/revise SOPs, controlled forms and deviations. Follow up on preventive and corrective actions associated with deviations. Education and Experience High Sch

Entry level position for persons to manufacture commercial scale batches. Essential Functions Production, filling and inspection of pharmaceutical formulations. Assist with facility cleaning and operational maintenance. Assist with facility and process validations as required. Perform aseptic production operations and validations. Aseptic qualifications consist of passing

Primary leadership role for clinical development strategy, protocol design across all clinical research trials in all projects across neurology. Direct authorship contributions in protocols, clinical study reports, and publications Lead and develop clinical development staff and oversee hiring of additional staff as needed. Interact with senior management and serve as a s

Alkermes is seeking an experienced IT Sr. Systems Analyst II within the Project Delivery group of IT. This individual will be responsible for delivery of IT solutions and applications across Commercial functions, which includes Sales Operations, Marketing, Market Access, Patient Access Services with some involvement with Medical Affairs. The ideal candidate will have subj

This position will provide technical leadership in the design, scale up, and optimization of small molecule pharmaceutical crystallization unit operations at various scales ranging from R&D to cGMP Phase III manufacture. Specific areas of focus include crystallization and support for CRO and CMO activities. Strong collaboration is expected with internal R&D groups, intern

The Senior Scientist position is primarily responsible for laboratory based design and execution of internal process chemistry activities for small molecule drug substances and intermediates, as well as providing technical oversight of external chemical process development and manufacturing by third party vendors from early phase clinical through process validation. The r

An entry level technician position involving general maintenance and preventive maintenance activities under direct supervision intended to keep the facility and equipment (i.e. process, utility, and general equipment) within operational specifications and safe. This position is part of a 24 hour/7 day operation and may require assignment to a regular off shift and weeken

Serve as strategic business partner to the product team Serve on the review committees for promotional materials and medical materials Provide legal counsel to commercial organization, including in respect of commercial program design, implementation and compliance with Federal and state anti kickback statutes, false claims acts, the Food, Drug and Cosmetic Act, HIPAA, pr