| Job Description | The Senior Scientist I position is responsible for developing and utilizing wet chemistry, chromatographic, and characterization techniques to enable drug substance and drug product development from pre-clinical 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. The position also requires extensive knowledge and application of the dissolution technique for both basic and complex drug product formulations. In addition, this position will also be responsible for writing protocols, development reports, SOP’s, train others on analytical techniques, be familiar with USP/NF analytical procedures, and have an understanding of cGMP’s and ICH guidelines. Technical leadership and mentoring of junior level scientists in the laboratory will be required.
Effective interaction with other technical, regulatory, research and manufacturing groups is critical. The Senior 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 methodology related. This individual should be 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, 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.
Adhere to cGMP’s in all work practices.
ICH Guidelines and Compendial Requirements
Attend training sessions as appropriate.
Assist in maintaining a clean, safe workplace on a daily basis.
Review peer's work as needed.
Review revisions to procedures as needed.
Write SOPs
Write and disseminate technical data summaries and reports
Contribute to CMC section reports.
Train other colleagues in methods and procedures.
Develop new chemical assays; write method qualification/validation protocols and reports
Lead team by ensuring execution of work assignments by laboratory staff to meet cycle times.
Routine work involvement and weekly meetings with laboratory team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other leaders for assistance and closeout of work activities.
Providing technical leadership through informal and formal training mechanisms.
Lead technology transfers
Develop technical strategies to meet customers technical and business needs
Evaluate and/or develop new technologies and identify proprietary technical opportunities for Alkermes
Direct and foster the professional development of scientific associates
Design experimental plans to address specific program issues
Lead technology transfers
Plan comprehensive stability studies
Interpret, analyze, and manage data
Prioritize tasks and responsibilities for projects.
Troubleshoot technical problems for development and manufacturing
Write project proposals, and development reports
Plan, write and execute validation and technology relocation protocols.
Present plans and data to key stakeholders and management
Coordinate activities of outside resources such as consultants, vendors
SKILLS/ABILITIES:
Advanced Analytical Chemistry (Dissolution, HPLC, GC, FTIR, UV/Vis, KF, LC/MS etc.)
Knowledge of pharmaceutical sciences
Statistical analysis for Analytical Chemistry
Computer applications and proficiency
cGMPs, ICH Guidelines and Compendial Requirements
Experimental design
Project planning and management
Collaborate in the design and execution of formulation and process development experiments
Oral and written communications
Data recording, interpretation, and management
Mentoring of junior staff
PERSONAL ATTRIBUTES:
Motivated self starter
Team player
Ability to lead small scientific group
Committed to quality
Well organized, efficient worker
Good interpersonal skills
Good problem solver
Critical, analytical thinker
Manages multiple duties and projects
Creative, innovative thinker
Developer of people
Easily adaptable to change
Brings closure to work in a timely manner
EDUCATION AND EXPERIENCE:
PhD in Chemistry with 3+ years of experience or Masters Degree in Chemistry with 8+ years of experience
Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established. |
| | Company | | Alkermes, Inc | Job Code | | State or Province | | Massachusetts | | |
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