Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for major clinical conditions with a focus on the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, multiple sclerosis and cancer. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes' website at www.alkermes.com.
The Senior Scientist position is responsible for providing technical leadership in laboratory programs for drug substance from pre-clinical to commercial filing. The primary responsibilities include analytical methods development and validation for wet chemistry, chromatographic, and characterization techniques, leading analytical investigations, process and product characterization for developmental, clinical, and marketed, drug product. In addition, this individual will also be responsible for writing and reviewing documents, protocols, development reports, SOPs, be familiar with USP/NF analytical procedures, and have an understanding of cGMPs and ICH guidelines.
Effective interaction with other technical, regulatory, research, and manufacturing groups is critical. This individual should be approachable, willing to learn new skills, assist on a wide variety of projects and be adaptable to new areas of research as priorities change within the department. This individual is required to work with teams comprised of scientists and non-scientists, to effectively coordinate efforts and track the progress of multiple projects within Alkermes and externally, and to provide technical leadership on interdivisional initiatives.
Serve as a subject matter expert for Research & Development
Author and review documents for regulatory submission
Generation of technical documents and technical presentations
Ensure execution of work assignments by self or laboratory staff to meet timelines
Lead development and validation of analytical methods for the characterization of drug substance
Present plans and data to key stakeholders and management
Collaborate in the design and execution of pre-formulation and DS and DP process development experiments
Develop technical strategies to meet technical and business needs
Troubleshoot technical problems for development and manufacturing
Prioritize tasks and responsibilities for projects
Evaluate and/or develop new technologies and identify proprietary technical opportunities for Alkermes
Providing technical leadership through informal and formal training mechanisms
Participate in technology transfers as necessary
Write and review analytical procedures and SOPs as needed.
Advanced analytical chemistry experience, including, but not limited to HPLC/UV, HPLC/MS, Wet Chemistry techniques, GC, GC/MS, NMR, FTIR, UV/VIS, KF, PSD, ICP, etc.
Understanding of organic chemistry and degradation pathways
Knowledge of pharmaceutical sciences
Computer applications and proficiency in Microsoft Office, ChemDraw, Chromatography Software(s)
Project planning and management
Oral and written communications
Data recording, interpretation, and management
Developer of people
Easily adaptable to change
Well-organized and efficient
Good interpersonal skills
Good problem solver
Critical, analytical thinker
Capable of managing multiple duties and projects
Creative, innovative thinker
Brings closure to work in a timely manner
EDUCATION AND EXPERIENCE:
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.