Lilly Senior Associate Manager - Analytical Development in Bengaluru, India
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 39,000 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 synthetic organic 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 utilize and provide support for IT systems and related processes that support GMP analytical testing (i.e. lot release and stability) for clinical trial materials. The team supports development and implementation of new informatics tools, as well as upgrades, troubleshooting, and maintenance for existing tools in production. Job responsibilities may include use and oversight of data and information in NuGenesis, Trackwise, Veeva Vault, and other systems; including participating in design, development, implementation, and maintenance of these systems and influencing the design and development of new informatics tools.
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 stability guidelines and other global regulations and guidance documents.
Demonstrates knowledge and understanding of GMP requirements, including CSV.
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.
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.
Partners with the GMP Lead, sample management and informatics groups to setup and manage lot release and stability data and studies in the LIMS system.
Generates, interprets, troubleshoots and effectively communicates 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 stability groups.
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.
Ensures the accuracy and completeness of written system documentation (e.g. CSV documents) by demonstrating appropriate attention to detail.
Participates as needed in system testing and validation activities.
Demonstrates understanding and experience with laboratory and stability systems and tools
Demonstrates proficiency in performing basic and complex operations in common informatics tools.
Demonstrates capability and expertise in utilization of Trackwise to document events and changes; familiar with ServiceNow.
Supports evaluation of new technologies and tools.
Demonstrates technical capability by design, execution, and support of analytical informatics tools; includes troubleshooting and resolving day-to-day performance issues.
Develops and maintains expertise in IT tools used to develop, review, and approve stability protocols, stability data, stability inventory, and stability reports.
B.S. or M.S. in Chemistry, Pharmaceutics or related field and significant pharmaceutical industry experience.
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 realization of team goals.
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 ( LillyRecruitingCompliance@lists.lilly.com ) 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.
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!