Lilly Biochem Associate Job – BSc, MSc Biotech Apply
Lilly Biochem Associate Job – BSc, MSc Biotech Apply. MSc Biotech and Biochem Associate – GMP Lead Team Analytical vacancy available. Lilly Associate – GMP Lead Team Analytical vacancy. Interested and eligible applicants can check out all of the details on the same below
Hey as a candidate applying for the Associate – GMP Lead Team Analytical role at Lilly, are you wondering what types of questions may be asked? Then read below
Name of the Post – Associate – GMP Lead Team Analytical
Location – Bangalore, Karnataka, India
Req ID – R-50120
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.
Overview of the organization:
Bioproduct Research and Development
(BRD) is an innovation-focused organization within Eli Lilly and Company. BRD is involved in key activities for the development of parenteral biologics drug substance and drug products including chemically synthesized biomolecule drug products from pre-clinical phases through commercialization. Our dynamic department is made up of molecular and cell biologists, purification and process engineers, pharmaceutical scientists, analytical chemists, and engineers. We strive to identify, develop, and apply groundbreaking technologies to deliver maximum benefit to our patients. BRD delivers on these responsibilities by recognizing diverse talent and cultures are vital to bring the next generation of life changing medicines to patients. BRD Analytical is a flexible, cross-functionally integrated, and capabilities driven team within BRD committed to providing state of the art measurement sciences to guide product and process understanding leading to optimized control strategies. Our mission is to elucidate understanding at molecular level, define critical quality attributes, integration of CMC knowledge, establish new platforms and technologies, and achieve regulatory acceptance to commercialize life changing medicines.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 a related field
Experience Requirements:
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
Here are a few possible questions that can be asked while you interview for the role of Associate – GMP Lead Team Analytical at Lilly
- Can you explain your experience in conducting GMP analytical testing for lot release and stability of clinical trial materials? How have you ensured compliance with cGMP requirements and regulatory guidelines? Answer: In my previous role, I was responsible for conducting GMP analytical testing for lot release and stability of clinical trial materials. I ensured compliance with cGMP requirements by following established procedures, guidelines, and regulatory standards such as ICH guidelines. This involved reviewing lot release and stability data for active pharmaceutical ingredients and dosage forms, utilizing various analytical instrumentation and techniques, and maintaining accurate documentation of results. I consistently ensured adherence to quality standards and regulatory compliance throughout the testing process.
- How have you managed technology transfers of analytical methods to third-party testing laboratories? Can you share an example of a successful transfer and the challenges you encountered during the process? Answer: During my experience, I have been involved in transferring analytical methods to third-party testing laboratories. One successful transfer involved collaborating closely with the receiving laboratory to provide comprehensive method documentation, training, and support. Challenges encountered during the process included aligning procedures and instrumentation, ensuring consistent method performance, and addressing any deviations in results between the transferring and receiving laboratories. Through effective communication, troubleshooting, and coordination, we were able to overcome these challenges and successfully transfer the methods.
- How do you ensure data integrity in analytical testing? What measures do you take to prevent or detect any potential issues? Answer: Data integrity is crucial in analytical testing to maintain the accuracy and reliability of results. To ensure data integrity, I follow good documentation practices, adhere to standard operating procedures (SOPs), and utilize electronic systems such as NuGenesis, Trackwise, and Veeva Vault to capture and manage data. I regularly review and verify the entered data to identify any anomalies or inconsistencies. Additionally, I actively participate in training and quality assurance programs to stay updated on data integrity best practices and regulatory requirements.
- Can you describe your experience in authoring protocols and stability reports for lot release and stability testing? How do you ensure the accuracy and completeness of these documents? Answer: In my previous roles, I have authored protocols and stability reports for lot release and stability testing. To ensure the accuracy and completeness of these documents, I follow established templates, guidelines, and regulatory requirements. I carefully review the data collected during testing, analyze trends, and interpret the results accurately. I also collaborate with cross-functional teams, such as regulatory representatives and QA representatives, to gather necessary inputs and ensure alignment with internal and external requirements.
- How have you demonstrated effective communication and collaboration skills within a laboratory setting? Share an example of a project where you successfully partnered with diverse stakeholders to achieve team goals. Answer: Communication and collaboration are essential in a laboratory setting, and I prioritize building effective working relationships with colleagues and stakeholders. In a recent project, we were tasked with developing a new testing method to improve efficiency and accuracy. I collaborated with laboratory personnel, regulatory representatives, and management to gather insights, define project objectives, and allocate resources effectively. Through regular communication, sharing of ideas, and open discussions, we successfully developed and validated the new method, leading to improved workflow and enhanced overall laboratory performance.
Note: The answers provided are for reference purposes and should be tailored based on the individual’s actual experience and achievements in the given role.
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