Scientist III, Analytical Development
Job Type:     Full-Time
Location:     Cambridge, MA


Job Description:

The Analytical Development Scientist position is responsible for developing and utilizing wet chemistry, chromatographic, and characterization techniques to support formulation, process development and manufacturing. The support consists of analytical methods development and validation, process and product characterization for developmental, marketed, and clinical drug product. This individual will have experience in HPLC method development of drug products and drug substances used in the manufacturing of pharmaceutical product. Additional experience with solid-state characterization techniques, e.g., DSC, TGA, XRPD, SEM, XPS and AFM are desirable. This position requires the ability to identify basic and complex technical issues that correspond to atypical or out-of-specification/trend test results, instrumentation and methodology related issues and the know-how to formulate and execute action plans to resolve and correct. 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. 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. Effective interaction with other technical, regulatory, research and manufacturing groups is critical. The incumbent 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. Technical leadership and supervision of junior level scientists may 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
    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 subordinates.
    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 customers and management
    Coordinate activities of outside resources such as consultants, vendors

SKILLS/ABILITIES:

    Advanced Analytical Chemistry (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
    Assist 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
    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 2+ years of experience, Masters Degree in Chemistry with 6+ years of experience, or Bachelors 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.