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: Sr. Scientist I-PhD in Chemistry with 3+ years of experience or Masters Degree in Chemistry with 8+ years of experience Sr. Scientist II-PhD in Chemistry with 5+ years of experience or Masters Degree in Chemistry with 10+ years of experience Other fields of specialty in Sciences are also acceptable provided sufficient chemistry coursework is completed and expertise established.
Phama Job Categories:
Research and Development