Senior Manager - Analytical Development

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Location

Waltham, MA

Summary

The Senior Manager – Analytical Development manages and oversees the activities and associates of an analytical chemistry group in efforts relating to analytical method development and validation. Provides strategic and operational direction ensuring that method development and validation studies are conducted in line with the appropriate expectations, guidelines and/or regulatory test standards (FDA, EU, Japan, USP, ICH, etc.).....

Full Description

Summary:       

The Senior Manager – Analytical Development manages and oversees the activities and associates of an analytical chemistry group in efforts relating to analytical method development and validation. Provides strategic and operational direction ensuring that method development and validation studies are conducted in line with the appropriate expectations, guidelines and/or regulatory test standards (FDA, EU, Japan, USP, ICH, etc.). This individual is responsible for the creation and validation of analytical methodologies for new and/or ongoing projects to support clinical and non-clinical material release and stability. The Senior Manager – Analytical Development performs analytical chemistry research to develop assays based on new and existing methodologies. Develops, establishes and validates testing methodologies and uses these methods to separate and characterize small and/or large molecules. Conducts work in compliance with cGMPs when necessary. Authors related documentation in the form of internal protocols and reports as well as summaries for presentations and regulatory filings. The Senior Manager - Analytical Development leads a team of analysts.

 

*Essential Duties and Responsibilities include the following. Other duties may be assigned.

  • Responsible for the creation and validation of analytical methodologies for new and/or ongoing projects to support clinical and non-clinical material release and stability.
    • Effectively and quickly creates analytical methods that address immediate needs.
    • Produces analytical methodologies that are suitably robust and meet requirements for potential use in a GMP environment.
    • Trains others to independently execute newly created analytical methods.
    • Maintains a database of method performance data and applies observed trends for continuous method improvements and to support development of method validation criteria.
    • Executes method validations addressing regulatory requirements that are suitably scoped to either support early phase or late phase/commercial release and stability efforts.
    • Develops strategies to ensure effective achievement of objectives by delegating responsibilities and organizing work flows while monitoring and evaluating the completion of tasks and projects.
    • Collaborates with other senior level personnel to ensure consistent application of company policies and practices as well as promoting new policies and programs tactfully and authentically.
    • Participates in the selection, development and evaluation of associates by providing ongoing guidance and support, and author/document performance reviews and/or evaluations.

 

  • Day to day supervision of an analytical team whose core function is to:
    • Support efforts relating to method development and validation.
    • Support investigations of the QC laboratory where analytical mythologies may be related and/or tangential to the investigative scope.
    • Maintain equipment related data for trending, continuous improvement and application of effective preventative maintenance procedures.
    • Perform routine release and stability testing as needed.
    • Continually optimize group operations to maximize efficiency.

 

Education and/or Experience:

  • Bachelor’s Degree in Chemistry or Analytical Chemistry required.
  • Minimum of 8-10 years of experience working in a cGMP regulated environment, developing & validating analytical methods required.
  • Prior supervisory and/or managerial experience required.

Supervisory Responsibilities:

  • Supervises a group of analytical chemistry associates with varying levels of experience.

Qualifications:

  • Ability to provide direction to a group and/or team of associates in a strategically efficient manner to ensure activities are completed on time and conducted in line with appropriate expectations, guidelines and/or regulatory test standards (FDA, EU, Japan, USP, ICH, etc.).
  • Experience in MDI/DPI analytical test methods preferred (i.e. Andersen Cascade Impactor and Emitted Dose Techniques).
  • Previous participation in regulatory audits of analytical data required.
  • Thorough knowledge of HPLC, GC, FTIR and various other analytical techniques required.
  • Experience with statistical data analysis, DOE, HPLC software systems, trending analysis preferred.
  • Experience with the full life-cycle of developing and validating analytical methodologies suitable for early phase clinical development to late phase/commercialization required.
  • Demonstrated ability to lead a team of analysts and multiple projects independently while having a positive impact on personnel and colleagues.
  • A strong foundation in analytical chemistry required
  • Ability to apply applicable regulations (FDA, EU, Japan, USP, ICH, etc.) in a phase appropriate manner required.

Computer Skills:

  • MS Suite, Empower or similar, JMP or similar, experience with an ELN

Certificates, Licenses, Registrations: none required

Other Skills and Abilities:

  • Excellent oral and written communication skills
  • Ability to effectively manage time and prioritize tasks independently
  • Demonstrates appropriate safety consciousness.

Physical Demands:

The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

 

  • Ability to lift up to 20 lbs.
  • Ability to stand for long periods of time
  • This position requires minimal travel; average travel for this position less than 10% with some variation based upon the demands of the business imperatives

 

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.

Ability to work safely and conscientiously in a laboratory environment; wear appropriate personal protective equipment; communicate with others in the laboratory to mutually ensure continued safe laboratory practices.

*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.