Senior Scientist / Team Leader Analytical Development

11 - 15 years experience  •  Biotech/Pharma

Salary depends on experience
Posted on 09/22/17
Waltham, MA
11 - 15 years experience
Biotech/Pharma
Salary depends on experience
Posted on 09/22/17

GENERAL DESCRIPTION:

 

The Senior Scientist/Team Leader Analytical Development (Small Molecule) will be responsible for enabling small molecule drug substance and/or drug product development from pre-clinical to commercial filing.  The position will also be responsible for the supervision and professional development of junior level scientists. 

 

The primary responsibilities for the position include analytical method development and validation, analytical investigations, process and product characterization, design of stability studies, and specification setting for developmental and clinical drug product. 

 

  • Extensive knowledge and application of HPLC and dissolution techniques for both basic and complex drug product formulations is required

     

  • 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

     

  • Willingness to learn new skills, assist on a wide variety of projects and be adaptable to new areas of development as priorities change within the department

     

  • Effectively coordinate and track the progress of multiple Analytical related projects

     

  • Provide technical leadership on interdepartmental initiatives through technical and CMC teams

     

  • Generation and dissemination of scientific and technical data/documents which may be included in regulatory submissions

                                                                                               

KEY DUTIES:

 

  • Develop new chemical assays; write method qualification/validation protocols and reports

  • Write and disseminate technical data summaries and reports

  • Evaluate and/or develop new technologies and identify proprietary technical opportunities

  • Contribute to CMC section reports

  • Direct and foster the professional development of scientific associates

  • Lead team by ensuring execution of work assignments by laboratory staff to meet timelines

  • 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

  • Develop technical strategies to meet technical and business needs

  • Design experimental plans to address specific program issues

  • Plan comprehensive stability studies

  • Interpret, analyze, and manage data

  • Troubleshoot technical problems

  • Write project proposals, and development reports

  • Present plans and data to key stakeholders and management

  • Coordinate activities of outside resources such as consultants and vendors

     

    SKILLS/ABILITIES:

     

  • Advanced Analytical Chemistry (Dissolution, HPLC, GC, FTIR, UV/Vis, KF, LC/MS etc.)

  • Knowledge of Pharmaceutical Sciences and Development

  • Statistical analysis for Analytical Chemistry

  • cGMPs, ICH guidelines and Compendia requirements

  • Collaborate in the design and execution of Analytical, Formulation and Process Development experiments

  • Oral and written communications

  • Project planning and management

  • Data interpretation, dissemination, and management

  • Prior supervisor experience is required

     

    PERSONAL ATTRIBUTES:

     

  • Motivated self starter

  • Team player

  • Ability to lead small scientific group

  • Committed to quality

  • Well organized, efficient worker

  • 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 10+ years of experience

    7619

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