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Senior Scientist, Analytical Development

Expired Job

Alkermes Waltham , MA 02154

Posted 4 months ago

Company Overview

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.

KEY DUTIES:

  • 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.

SKILLS/ABILITIES:

  • 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)

  • Experimental design

  • Project planning and management

  • Oral and written communications

  • Data recording, interpretation, and management

PERSONAL ATTRIBUTES:

  • Self-motivated

  • Developer of people

  • Easily adaptable to change

  • Team player

  • 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:

  • PhD in Chemistry with 3+ years of experience or Master's Degree in Chemistry with 10+ years of 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.

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Senior Scientist, Analytical Development

Expired Job

Alkermes