What are the responsibilities and job description for the Scientist III, Analytical Development position at MannKind Corporation?
At MannKind, our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.
Job Summary:
Perform analytical chemistry to develop assays based on new and existing methodologies to support development/commercialization projects. Develops, establishes and validates testing methodology used to control raw materials, production intermediates and final products. Sets up new or existing methods for identifying and quantifying compounds, their validation and documentation. Conducts testing of analytical samples for the separation and characterization of drug candidates to support process development / commercialization. Conducts work in compliance with cGMP, safety and regulatory requirements. Provides analysis and evaluation of material and products at all stages of development process.
Essential duties and key job responsibilities and essential functions.
Job Summary:
Perform analytical chemistry to develop assays based on new and existing methodologies to support development/commercialization projects. Develops, establishes and validates testing methodology used to control raw materials, production intermediates and final products. Sets up new or existing methods for identifying and quantifying compounds, their validation and documentation. Conducts testing of analytical samples for the separation and characterization of drug candidates to support process development / commercialization. Conducts work in compliance with cGMP, safety and regulatory requirements. Provides analysis and evaluation of material and products at all stages of development process.
Essential duties and key job responsibilities and essential functions.
- Act independently to determine methods and procedures on new assignments.
- Perform experiments in accordance with written procedures and/or under the direction of a supervisor.
- Initiate, execute and manage validations for established methods with minimal supervision.
- Manage equipment calibrations/qualifications with minimal supervision.
- Develop analytical methods using advanced analytical instrumentation and techniques.
- Assist in the development and training of peers and less skilled employees in the execution of analyses and/or the use of specialized equipment.
- Represent the group at appropriate meetings.
- Responsible for observing all Company, Health, Safety and Environmental guidelines.
- Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary.
As a member of the development organization at MannKind Corp. the incumbent is also expected to use quantitative reasoning; and to be professional, committed to excellence, customer focused, detail oriented a communicator, and a team player.
(Where reference is made to regulatory environment requirements and/or compliance this includes all applicable regulations i.e. FDA, ISO 13485/9001, European requirements, etc.)
Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties; physical requirements for job if any.
- BS Degree in Chemistry with 4-6 years or MS Degree with 2-4 years or PhD Degree with 0-2 years related experience.
- A working understanding of /experience in GMPs and regulatory guidance.
- Experience with the development and validation of analytical methods.
- Ability to think analytically along with good communication, organizational and interpersonal skills.
- Must have experience in HPLC analysis and other required analytical techniques.
- Proficient in the use of a word-processing and spreadsheet program.
- Understanding of GMPs and regulatory guidelines as they relate to the pharmaceutical products preferred.
- Experience with the development and validation of analytical methods preferred.
- Good analytical chemistry and quantitative and qualitative analytical skills.
- An understanding of the basic statistical concepts and working knowledge of one or more statistical and other technical software packages.
- Access, Excel, Word and Power Point skills.
Salary : $73,600 - $110,400
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