|Description: Shionogi Inc. is the U.S subsidiary of Shionogi & Co., Ltd., a leading Japanese pharmaceutical company. We are in a unique position of having the financial backing and the research capabilities of a well-established leading Japanese pharmaceutical company, matched with the entrepreneurial spirit of a start-up company.
Shionogi Inc. develops and commercializes pharmaceutical products that address unmet medical needs in the areas of cardiovascular disease, diabetes, pediatric conditions, and womens health. Together with our Japanese corporate parent, Shionogi has been providing innovative medicines essential to people's health for over 130 years.
We are seeking dynamic, focused and creative individuals to join our growing team. We are currently expanding our workforce in our New Jersey headquarters location and looking for experienced pharmaceutical professionals to help us build for the future.
Essential functions of the Pharmaceutical Scientist Analytical Chemist include the application of a broad range of pharmaceutical science knowledge towards the successful efforts to develop commercial products that are safe, effective, and robust.
The Analytical Chemist works as part of a team to provide analytical testing support for stability studies and technology transfers. Will be focused on specialized testing for API, raw materials and finished dosage forms. and supports multiple projects at multiple phases of development.
Job responsibilities include performing analytical testing to evaluate stability qualification, verification, and validation of analytical methods; and transfer of analytical methods and techniques to manufacturing sites and third party testing laboratories.
Interact with outside vendors in support of development projects and marketed products.
Coordinate activities of multiple laboratories located at THIRD PARTY VENDORS in support of management of development projects and post-marketed products.
Maintain working knowledge of available pharmaceutical technology in the marketplace and evaluate suitability for use with current or future development projects; as well as marketed products.
Provide project updates (monthly reports, data summaries) to management.
Participate in the development of validation strategies for new products and processes, and be involved in assessment of change control requests from vendors, risk assessments and have input into annual product reports.
Serve as primary liaison to development laboratory for key projects, and liaison with Shionogi Japan colleagues regarding technical transfer issues.
Provide technical support for Supply Chain, Quality Assurance (QA) and Regulatory Affairs Departments.
Be responsible for Risk Management activities including risk assessment, impact analysis and Failure Modes and Effects Analysis (FMEA).
Participate with manufacturers in diagnosing areas in need of process definition or improvement, and assist in the design and implementation of new or revised processes, methods and practices.
Acts as the Technical Lead on multidisciplinary development teams, the candidate will have the responsibility and authority to make technical recommendations and decisions that directly impact the project timeline and budget.
Demonstrates technical capability by performing multiple analytical methods for the analysis of API, raw materials and finished products.
Develops, verifies, qualifies, validates and transfers analytical methods. Authors method documents.
Generates, interprets, troubleshoots and effectively communicates (both in writing and orally) analytical information to team members, project leaders, and customers.
Demonstrates good documentation skills, with established proficiency in data reporting, data interpretation and data trending.
Conducts or leads OOS and aberrant data investigations and deviation investigations.
Demonstrates good laboratory skills, including sample preparation proficiency and comprehensive knowledge of set-up, operation, and troubleshooting of analytical instrumentation.
Manages project deliverables and multi-tasks to provide support for multiple projects.
BS/MS in Chemistry
Minimum of 4 years analytical laboratory experience in a GMP regulated environment
Must offer experience working with THIRD PARTY VENDORS and CONTRACT MANUFACTURERS
Experience in parenteral drug product pharmaceutical development or manufacturing
Successful hands-on analytical testing experience in a GMP environment
Qualified candidate must be legally authorized to be employed in the United States
Demonstrated laboratory skills and attention to detail
Experience and knowledge of analytical laboratory GMP requirements for clinical trial materials
Demonstrated capability to design and execute method development, qualification verification, and/or validation protocols and experiments
Demonstrated capability to perform technical review of laboratory testing results and to identify and investigate suspect results
Strong documentation and communication skills
Strong organizational skills and ability to multi task across projects and activities
Demonstrated ability to troubleshoot analytical methods and equipment.
Experience and use of CAPA/Trackwise
Must be able to travel up to 40% - includes international; must reside with in a commutable distance to offices.
Our employees are considered the most valued part of our organization. We demonstrate this commitment to our employees by offering a competitive salary and a comprehensive employee benefits package.
To be considered for this position, you must apply below and meet the requirements of this opportunity. We look forward to reviewing your resume and qualifications.
Shionogi Inc. is an equal opportunity employer proud to support diversity in the workplace.
Shionogi Inc. does not accept unsolicited third party resumes.
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