This role does NOT offer sponsorship for work authorization. External applicants must be eligible to work in the US without any visa sponsorship or visa transfer requirements.
Summary
This role oversees a team of analytical scientists assigned to 2nd Shift Hours: 4pm-12am, Monday-Friday. The role is located on-site in Weston, FL. The 2nd Shift requirement is non-negotiable. The Manager p rovides subject matter expertise on all topics Analytical Sciences. Provides scientific and technical leadership in identification, selection and implementation of analytical techniques that may be suitable for the portfolio of projects. Drafts and reviews scientific documents that are commensurate with the requirement of global regulatory authorities e.g., US FDA, EMA, MHRA. Oversees conduct of standard and advanced laboratory activities. Independently designs, conducts, leads, supervises and troubleshoots, physico-chemical characterization studies with a focus on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP) following cGMPs. Leads evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMPs, Transpire Bio EH&S and other relevant guidelines. Leads development of extractables and leachables (E&L) analytical methods in support of product development. Leads the development and evaluation of new physico-chemical characterization and aerosol analytical technologies where required. Analyzes and summarizes analytical data using advanced tools including statistical packages. Initiates investigations and data reviews.
Essential Duties and Responsibilities
Qualification Requirements
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