Scientist I, Analytical Development

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POST DATE 8/12/2016
END DATE 12/2/2016

Alkermes Waltham, MA

Waltham, MA
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Full Time
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Company Overview

Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for 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, addiction and multiple sclerosis. 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 .

Job Description:

The Scientist I position is responsible for developing and utilizing chromatographic, characterization, and wet chemistry techniques to enable drug substance (primarily small molecules) and drug product development from pre-clinical studies to commercial filing. The primary responsibilities include analytical methods development and validation, analytical investigations, process and product characterization for developmental, clinical, and marketed drug product. In addition, this position will also be responsible for writing protocols and development reports, training others on analytical techniques, being familiar with USP/NF analytical procedures, and having an understanding of cGMPs and ICH guidelines. Technical leadership and mentoring of junior level scientists in the laboratory will be required.

Effective interaction with other technical, research, manufacturing, regulatory, and quality groups is critical. Some travel may be required. The Scientist I position requires the ability to identify and solve complex technical issues that correspond to atypical or out-of-specification/trend test results as well as instrumentation and related methodology. This individual should be willing to learn new skills and techniques, 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, and to provide technical leadership on interdivisional initiatives. Support and generation of scientific/technical documents, which may be included in regulatory submissions, will be required.

Key Duties:

* Perform and record analyses as assigned on a daily basis

* Develop, validate, and transfer methods for analysis of drug substance and drug product

* Design experimental plans to address specific program issues

* Design and plan stability studies

* Interpret, analyze, and manage data

* Prioritize tasks and responsibilities for projects

* Troubleshoot technical problems for development and manufacturing

* Present plans and data to key stakeholders and management

* Provide technical leadership through informal and formal training mechanisms

* Adhere to cGMPs in all work practices, when required

* Attend training sessions as appropriate

* Train other colleagues in methods and procedures

* Assist in maintaining a clean and safe workplace on a daily basis

* Review peer's work

* Review revisions to procedures as needed

* Write and disseminate technical data summaries and reports

* Contribute to CMC section reports

* Lead technology transfers to other Alkermes sites and contract organizations

* Coordinate activities of outside resources such as consultants

* Develop technical strategies to meet customers technical and business needs.

* Evaluate and/or develop new technologies and identify proprietary technical opportunities for Alkermes


* Advanced analytical chemistry (HPLC/UHPLC, GC, Dissolution, FTIR, UV/Vis, KF, LC/MS, etc.)

* HPLC and GC method development, with emphasis on small molecules

* Strong instrumental background with comfort in troubleshooting and minor maintenance

* Knowledge of pharmaceutical sciences

* Statistical analysis for analytical chemistry

* Proficiency with computer applications

* Understanding of cGMPs, ICH guidelines, and compendial requirements

* Experimental design including application of QbD

* Design and execution of formulation and process development experiments

* Oral and written communications

* Data recording, interpretation, and management

* Mentoring of junior staff

Personal Attributes:

* Self-motivated

* Team player

* Committed to quality

* Well-organized, efficient worker

* Good interpersonal skills

* Good problem solver

* Critical, analytical thinker

* Manages multiple duties and projects

* Easily adaptable to change

Education and Experience:

* Significant experience in analysis of small molecule drugs

* Masters Degree in Chemistry with 3-5 years of experience or Bachelors Degree in Chemistry with 6+ years of experience

* Other fields of specialty in sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established.

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, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.