Associate at Eli Lilly And Company. Interested Candidates can check the below details and apply online.
Job role: Associate – GMP Lead Team Analytical
Job ID: R-50120
Job Location: Bangalore, Karnataka, India
Department: Research & Development
Employment Type: Full time
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Main Purpose and Objectives of Position:
As part of a multi-disciplinary team in BRD Analytical, the incumbent will provide support for GMP analytical testing (i.e., lot release and stability) for clinical trial materials, primary stability studies and technology transfers. Job responsibilities include Data Integrity review of analytical data for 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 basic understanding of the following:
- Develops/maintains awareness and familiarity of ICH guidelines and other global regulations and guidance documents per GMP requirements.
- Review of lot release and stability data for active pharmaceutical ingredients and pharmaceutical dosage forms in the LRL portfolio.
- Various analytical instrumentation and techniques (e.g., HPLC, CE, UV, various types of compendial testing)
- Demonstrates project management and other key analytical skills.
- Develops and maintains successful partnerships with other Lilly scientists, regulatory representatives, QA representatives and third-party collaboration partners.
- Author protocols and stability reports 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.
- Experience with laboratory and stability systems/ tools in performing basic operations in common informatics tools
Educational Requirements: B.S. or M.S. in Chemistry, Pharmaceutics, Biochemistry, Biotechnology, or related field
Experience Requirements for Associate at Eli Lilly And Company:
For the above activities, an individual in this role requires:
- Fundamental knowledge of cGMP compliance requirements and pharmaceutical stability principles.
- 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 realization of team goals.
- Customer-focused attitude
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( [email protected] ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
#WeAreLilly
Possible interview questions with answers for the role of Associate at Eli Lilly And Company:
1.Can you explain your experience with GMP compliance requirements and how you ensure adherence to pharmaceutical stability principles in your work?
Answer: In my previous role, I was responsible for conducting GMP analytical testing for clinical trial materials and stability studies. To ensure compliance with GMP requirements, I always kept myself updated with ICH guidelines and other global regulations. I closely followed standard operating procedures (SOPs) and regularly reviewed them to identify any gaps or areas for improvement. Additionally, I maintained detailed documentation to track stability data and temperature excursions for both active pharmaceutical ingredients and dosage forms. By adhering to these practices, I ensured that our analytical processes met the highest GMP standards.
2.How do you approach authoring protocols and stability reports for lot release and stability testing? Can you provide an example of a successful project you’ve managed in this regard?
Answer: When authoring protocols and stability reports, I begin by thoroughly understanding the specific requirements for lot release and stability testing of the product. I collaborate with cross-functional teams to gather all relevant data and information. For instance, in my previous role, I led a project where we were evaluating the stability of a novel pharmaceutical dosage form. I worked closely with scientists, QA representatives, and regulatory experts to define appropriate testing parameters and timelines. By efficiently coordinating these efforts, we successfully released the product for clinical trials, meeting the established stability criteria.
3.How do you ensure the accuracy of data and information entered into IT systems during GMP analytical testing? Can you share a situation where your attention to detail made a significant impact on the outcome of a project?
Answer: To ensure data accuracy, I employ a systematic approach during data entry into IT systems. I double-check all entries against the corresponding records and cross-verify them with the established protocols. Additionally, I leverage informatics tools and review functionalities to detect any anomalies or inconsistencies in the data. In one instance, during a routine stability testing analysis, I noticed a discrepancy in the results. Upon careful investigation, I discovered a minor calibration issue with the analytical instrument. By promptly addressing this issue and recalibrating the instrument, we prevented potential inaccuracies in subsequent testing, ensuring reliable and precise results.
4.How do you manage your interactions with diverse groups, such as laboratory personnel, contractors, and management, while working on analytical projects? Can you provide an example of a successful collaboration?
Answer: Effective communication is crucial in my role, especially when collaborating with various stakeholders. I ensure open and transparent communication with laboratory personnel to convey project requirements clearly and foster a positive working environment. Additionally, when dealing with contractors and management, I emphasize building strong partnerships based on mutual respect and understanding. In a recent project, we had to transfer an analytical method to a third-party testing laboratory. I collaborated closely with their team, providing comprehensive documentation and clear instructions. Through regular progress meetings and open discussions, we successfully completed the method transfer, ensuring seamless collaboration and accurate analytical results.
Associate at Eli Lilly And Company
Stay tuned on RASAYANIKA for more chem and pharma related job updates.
