Manager of Analytical Chemistry
Has overall responsibility for the Analytical Chemistry department. Supervise and provide career development and training for analytical chemistry personnel. Build and maintain technologies necessary to serve Analytical Chemistry clientele. Has responsibility for department compliance with applicable regulatory guidance documents and QA policies and directives. Interfaces with clients regarding technical issues and to build external scientific and client relationships. Provide technical expertise to the department.
Essential Duties and Responsibilites
- Develop or supervise development of experimental designs
- Prepare, review, and approve GMP and GLP protocols and reports
- Provide scientific expertise for the interpretation and evaluation of results generated in the Analytical Chemistry department
- Review data generated by other Analytical Chemistry personnel
- Develop, validate, and document analytical methods as needed
- Interface with clients as needed
- Identify and manage staffing requirements and assignments
- Supervise technical personnel and delegate responsibilities
- Interface with clients as needed – building client base
- Work with Client Services to prepare quotes and proposal developments
- Evaluate equipment and resource requirements
- Process improvements
- Prepare and/or review Regulatory and Quality documentation
Qualification Requirements/Training Programs
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
- PhD in Analytical Chemistry or a related science preferred but appropriate combination of education and experience acceptable.
Expertise and experience required
- Five years plus general analytical chemistry knowledge and experience or equivalent combination of education and experience. Strong expertise and experience with instrumental Analytical techniques and equipment (i.e. GC-MS, LC-MS), method development, and structure elucidation in the industry setting
- Experience in management of personnel
- GMP and/or GLP experience preferred
Qualifications and training program
Facile with Microsoft Office (Word, Excel, PowerPoint), email programs (Microsoft Outlook, Lotus Notes), and programs specific to the lab instrumentation. Able to perform statistical calculations.
Ability to read, analyze, and interpret technical procedures. Ability to write reports, correspondence, and procedures. Ability to effectively present information and respond to questions. Ability to interpret results and communications in writing, utilizing appropriate scientific terminology.
Math skills required with ability to understand and manipulate simple to complex equations including exponential and logarithmic functions. Must know basic statistical analysis.
Technical problem solving including evaluation of results, instrument troubleshooting, comparisons of data.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to sit, stand and walk, use hands to manipulate objects or controls, reach with hands and arms, talk and hear. The employee may occasionally be required to climb, balance, stoop, kneel, crouch, or crawl.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Combination of office and laboratory settings with the potential for occasional exposure to fumes or airborne particles, toxic or caustic chemicals, and biological hazards. Moderate noise levels exist. Some industrial setting (e.g., contract sterilization). Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.