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Analytical R&D Supervisor

Job Description:        MPP Group, LLC, Mequon, WI is seeking a Supervisor, Analytical R&D, reporting to the Manager of Analytical Sciences. Primary responsibility will be in development, validation, and implementation of analytical methods allowing the company to continue a development of robust formulations of Injectable Drug Products to be approved by FDA. Specific job duties will include: Responsible for development and validation of new analytical methods, development of new analytical technologies including associated standard operating procedures, and training of staff; Developing and driving overall analytical testing strategy for API and formulated drug products; Leading all analytical activities within a global project team (e. g. specification setting, method development and validation, stability and release testing); Accountable for meeting quality standards, timelines and budget for assigned projects; Proactively identifying scientific, technological and GMP issues and proposing creative, science based solutions; Providing input into CMC documents to support regulatory submissions; Contributing to advance scientific and technological innovations within ARD.

 

Qualifications:  Requires a Ph.D. in Chemistry, Pharmacy, or related field, plus 2 years of experience in a pharmaceutical ARD setting in each of the following areas: development of pharmaceutical ARD; development and testing of pharmaceutical raw materials and/or drug products for human health; HPLC, GC, GC-MS, and HPLC/MS method development and validation; writing scientific documentation, protocols and validations; supervisory experience in an analytical setting; Food and Drug finished product testing.

 

In lieu of the Ph.D. plus 2 years of experience requirement, we would accept a M.S. in Chemistry, Pharmacy, or related field, plus 5 years of experience in a pharmaceutical ARD setting in each of the following areas: development of pharmaceutical ARD; development and testing of pharmaceutical raw materials and/or drug products for human health; HPLC, GC, GC-MS, and HPLC/MS method development and validation; writing scientific documentation, protocols and validations; supervisory experience in an analytical setting; Food and Drug finished product testing.

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