Method Validation applies to analytical procedures used to determine chemical identity, potency and purity of pharmaceutical products manufactured at Luitpold Pharmaceuticals, Inc. in Shirley, New York, and does not apply to microbial or environmental testing. The MV Chemist, Level II, will perform analytical validations according to current guidance and established procedures for analysis of raw materials, bulk, finished product, stability samples, process cleaning and process validation samples in the Quality Control Laboratories.
Develop methods for Stability and QC Chemistry.
Write technical protocols and reports based on Method Validation requirements.
Perform Method Validation on QC Chemistry methods and procedures.
Perform technology transfer of analytical methods between R&D and QC Chemistry Dept.
Perform validation of new equipment/software, and introduction of new tests or procedures in the laboratory.
Offer input/suggestions for improvement in laboratory operations and procedures.
Initiate change control to methods and procedures requiring modifications.
Perform calibrations and troubleshooting on laboratory equipment.
Maintain well organized documentation regarding all activities listed above.
Maintain inventory of laboratory supplies and order supplies when necessary.
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.
BS Degree in Chemistry or related science with a minimum of three (3) years in pharmaceutical laboratory or MS Degree in Chemistry or related science with one (1) year pharmaceutical experience.
Strong oral and written communication skills
Strong background in Analytical Instruments, Methods Development, and Method Validation.
Strong organizational and time management skills.
Knowledge of Empower, Microsoft Word, and Microsoft Excel required.
We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race,
color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.