Lilly Hiring BSc & MSc Chemistry Candidates – Associate Scientist
Lilly Associate Scientist – GMP Post Chemistry job opening at Lilly. Pharma job opening at Lilly. Chemistry job opening at Lilly. Lilly Associate Scientist – GMP– Applications Invited.Associate Scientist – GMP Job Opening.Associate Scientist – GMP vacancy 2022.
Job Title: Associate Scientist – GMP
Educational Requirements
B.S. or M.S. in Chemistry, Pharmaceutics or related field and significant pharmaceutical industry experience.
Experience Requirements
For the above activities, an individual in this role requires:
- Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
- Previous pharmaceutical industry experience (at least 3-5 years) required
- Good documentation skills and ability to author and/or review standards, guidelines, SOPs, templates, protocols, and other GMP documentation.
- Excellent general computer skills (MS Excel, Internet Explorer, PowerPoint, MS-Word) and the ability to compile, summarize and present information to diverse groups.
- Excellent communication skills and willingness to interact with laboratory personnel, contractors and management.
- Ability to troubleshoot problems and identify solutions.
- Ability to influence and partner with individuals outside of a formal reporting relationship towards the realization of team goals.
- Customer-focused attitude
Main Purpose and Objectives of Position
As part of a multi-disciplinary team in BRD Analytical, the incumbent will
provide oversight and support for GMP analytical testing (i.e. lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include providing oversight for the analysis of a variety of active pharmaceutical ingredients and dosage forms to evaluate stability, and support clinical trial materials; qualification, verification, and validation of analytical methods; transfer of analytical methods and techniques to third party testing laboratories; and reference standard support activities. These activities may include use of data and information in NuGenesis, Trackwise, Veeva Vault, and other systems.Key Responsibilities
- Understands and follows all relevant policies relating to this job including business, compliance, regulatory, quality, environmental, and safety expectations. May participate in the development and review of procedures, policies, and training materials associated with the area.
- Demonstrates understanding and experience with GMP requirements
- Develops and maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents.
- Demonstrates strong analytical skills
- Demonstrates technical capability in reviewing and interpreting lot release and stability data for a select number of active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
- Oversight of transfer/verification/qualification/validation of methods to support in-process, release, characterization analysis, and stability testing of active pharmaceutical ingredient and drug product.
- Experience with various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)
- Demonstrates project management and communication skills
- Efficiently and effectively manages project deliverables to provide support for multiple projects in multiple phases of development.
- Effectively guide and oversee external work at collaboration partners.
- Generates, interprets, troubleshoot, and effectively communicates (both in writing and orally) relevant information to management, team members, project leaders, and customers.
- Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives, and third-party collaboration partners
- Demonstrates good documentation skills
- Author protocols, reports, and change controls to support lot release and stability testing, dating, temperature excursions, and registration of API and drug product.
- Ensures the accuracy of the data/information entered into IT systems.
- Demonstrates proficiency at data reporting, interpretation, and trending (e.g., Empower chromatography software and electronic laboratory notebooks).
- Demonstrates understanding and experience with laboratory and stability systems and tools
- Demonstrates proficiency in performing basic operations in common informatics tools.
- Demonstrates capability and expertise in the utilization of Trackwise to document events and changes; familiar with ServiceNow.
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