Scientist Data Steward

About the job

Job Description

Works as an individual contributor on one or more project teams cross functionally within analytical. Job responsibilities include performing activities for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability and support clinical trial materials; testing raw materials and excipients; generation/review of release and stability data; qualification verification validation and transfer of analytical methods and techniques to manufacturing sites and third party testing laboratories ensure consistency of analytical testing across sites as necessary (both internal and external laboratories) while meeting compliance requirements. Apply cGMP practices during execution of routine testing. Lead and/or provide input to investigations using scientific techniques to resolve laboratory related issues by performing indepth problem solving proactively identifying opportunities for continuous improvement and completing thorough investigations of aberrant data and results.

Key Responsibilities

• Awareness understands and follows all relevant policies relating to this job including business compliance regulatory (cGMPs) quality environmental and safety expectations. Makes sound technical decisions and appropriately communicates these decisions to other scientists and management.
• Demonstrates technical excellence at performing assessing and troubleshooting multiple analytical methods. Displays comprehensive knowledge of instrument setup operation and troubleshooting (e.g. HPLC CE ELISA qPCR Bioassay Karl Fischer UV compendial and parenteral tests particulates).
• Openly shares technical knowledge and key learning.
• Efficiently and effectively manages project deliverables to provide support for multiple projects at multiple phases.
• Establishes and maintains key relationships within BRD and Testing Labs.
• Identifies internal and external customer requirements and develops solutions to meet customer needs.
• Demonstrates proficiency at data review analysis reporting interpretation and trending (e.g. Empower NuGenesis (eLN)) including batch release stability and method installation data.
• Demonstrates good documentation skills with regard to raw data recording and authoring of documents.
• Participates in investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent recurrence. Utilize technical writing strategies to ensure content is clear concise and complete.
• Participate in inspection readiness activities and support regulatory inspections. Participate in internal/external audits as needed.
• Author and track the implementation of change controls and all other compliance requirements relevant to department projects.
• Use scientific expertise to assist with troubleshooting laboratory investigations OOT/OOS/aberrant data and problem resolution. Participates in the root cause analysis and improvement of processes with technical and nontechnical solutions that help to improve efficiencies within the department and prevent reoccurrence of deviations. Develop investigational testing protocols in support of analytical investigations and performs/oversees testing as required.
• Subject Matter Expert in instrumentation including installation operation and performance qualifications of instrumentation. SME in methods and troubleshooting.

Educational Requirements

• BS/MS in analytical sciences or equivalent pharmaceutical degree with at least 3 years relevant experience in Analytical field.
• Experience Requirements
• For the above activities an individual in this role requires:
• Fundamental knowledge of cGMP compliance requirements and regulatory expectations.
• Good documentation skills and ability to author and/or review standards GMP guidelines SOPs templates protocols and other documentation.
• Excellent general computer skills (MS Excel Internet Explorer PowerPoint MSWord JMP) and the ability to compile summarize and present information to diverse groups.
• Familiarity with Microsoft Office Tools. Skills in Power BI Python and database tools are nice to have.
• Ability to troubleshoot problems and identify solutions.
• Customerfocused attitude.
• Experience with a variety of root cause methodologies.
• Must have good interpersonal skills and be able to work effectively and efficiently in a teambased environment internally and with external partners.
• Demonstrated learning agility and ability to think creatively try new ideas and apply learnings and strong problemsolving skills.
• Highly flexible adapting to changes in priorities requirements and processes.
• Demonstrate proficiency in complex laboratory analysis including but not limited to chromatographic spectroscopic immunoassay DNA and/or microbiological assays.
• Ability to work in a lab environment and following safety guidelines.

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Remote Work :

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