Shionogi Inc.
Manager, Pharmaceutical Sciences (Florham Park, NJ) (Biotech)
Lead and develop process validation strategies for small molecule oral solid formulations and manufacturing processes of new chemical entities (NCE) drug products across a global organizational network; Work with external partners and cross-functional teams including quality, supply chain and regulatory to ensure creative and efficient implementation; Develop and design process development studies using Design of experiments (DOE) strategies; Conduct optimization and scale up from lab to commercial scale equipment; Evaluate new pharmaceutical technologies and make recommendations for future pharmaceutical product development; Review and approve IQ/OQ/PQ protocols and reports for equipment qualification; Apply advanced knowledge of cGMP's and associated CMC quality systems and regulatory considerations in development of late phase clinical supplies & commercialization of pharmaceutical products; Perform quality risk assessment using risk assessment tools and utilize pharmaceutical development expertise to design continuous process verification plans for commercial drug product; Employ statistical process control (SPC) methodologies using Minitab to trend and monitor commercial product data to enable robust and continued supply to market; Conduct regression modeling & extrapolation of stability studies in order to predict product shelf life/ retest period.
Must have a Master's degree in Chemistry or Pharmaceutical Sciences plus 1 year experience in job offered or as Sr. Scientist. Require skills and knowledge of Oral solid dosage formulations, Six Sigma black belt, NCEs, DOE, SPC, Minitab, cGMP, IQ/OQ/PQ. Require 30% domestic and international travel to contract business partners. Allow Telecommuting.
Job location: Florham Park, NJ. Send rés w/code DHR002 to HR, Shionogi, Inc, 300 Campus Dr, Florham Park, NJ 07932.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)
Scientific