4 Bioanalysis Jobs

Summary Laboratory Excellence and Operation (LEO) and Biomarker Science and Operation (BSO) team in India are the key global resources for Line functions (LF) and Translational Medicine (TM) Clinical Trial Teams for biomarkers including biomarker outsourcing, scientific biomarker monitoring, vendor management, biomarker logistics, clinical site communication and sample coordination. LEO/BSO are working in close collaboration with clinical teams, LF technology experts, Biomarker Leads (BMLs) as well as external service providers (ESP) including central labs and clinical sites. About The Role Your responsibilities include, but are not limited to: Independently provide operational support to Biomarker Study Experts and clinical studies focusing on biomarker samples and including reviews of clinical study protocol, preparing site operations manuals, informed consent forms, sample collection table, instruction manual, central lab protocol/manual, and eCRF and other biomarker sample operation logistics and coordination including study setup, sample tracking/reconciliation, assay and vendor set up, sample/data upload and study closure Support data transfer and data flows in LIMS and DTS (e.g. study creation, data flow, data transfer, etc.) for managed biomarkers and studies. Update study and project information in relevant reports and IT systems Independently identify and resolve sample management and sample discrepancy issues Identify, and escalate issues, ESP, quality or performance issues and engage LF experts/SME, clinical trial leaders and data management as needed. Contribute to the best practices, process. Continuous improvement initiatives and innovations in sample management functions Collaborate with other TM, BMD and GCO functions BS in life science with 4+ years of clinical operations experiences and/or clinical bioanalysis and/or clinical biomarkers. Advance degree with 2 years in clinical operations and/or clinical bioanalysis and/or clinical biomarkers Operational knowledge of clinical trials: clinical study set up, clinical sample management, clinical sample analysis and managing external service provider (ESP) including central laboratories and/or specialized vendors Laboratory background and knowledge immunoassay and/or bioanalysis Knowledge of the drug development process, clinical biomarkers and working with translation clinical research. Strong project and time management skills, problem solving, communication and leadership skills. Knowledge of regulatory requirements e.g. ICH/GCP, GLP, etc. WHY NOVARTIS 769 million lives were touched by Novartis medicines in 2020, and while were proud of this, we know there is so much more we could do to help improve and extend peoples lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the worlds toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment To Diversity & Inclusion Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network,

Job Title : Study Director - Pharmacokinetics and Immunogenicity Assays Job Location: Bangalore Department: Immunogenicity Research Laboratory - Translational & Clinical Research Job Purpose: The position holder is responsible for performing bioanalysis which includes performing ligand binding assays related to Pharmacokinetics and Immunogenicity. Key Responsibilities: Ensure activities conducted in the bioanalytical lab are in compliance with established SOPs, procedures, systems, regulatory guidance without deviating from established procedures. Regular interaction and participation with Study director, Quality Control (QC) and Quality Assurance (QA) during raw data and reports review, closure of observations and archival. Will be involved in strategic planning for project execution, documentation of data, data analysis, interpretation and presentation of the results • Ensure to complete the assigned tasks in timely manner. Actively involved in preparation of SOPs, protocols, method and reports Prepare reagents, buffers and maintain log book for assigned assays Interpret results - anticipate and understand the issues related to the assay. Participate in, and present data for discussions. Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety. Attend training on environment, health, and safety (EHS) measures imparted company Educational Qualification: Master's degree or Ph.D in Biological Sciences (Preferably Biochemistry background) or a related field Technical/functional Skills: Should have a strong background in immunoassay and bioanalytical Pharmacokinetics and Immunogenicity Assays with a good understanding as per regulatory guidance/ industry practices/internal Standard Operating Protocols. Should have hands-on experience in Ligand Binding Assay (LBA) development, validation and Sample analysis. Knowledge of ELISA and MSD assays are highly desirable. Knowledge and experience with regulatory requirements e.g. Organization for Economic Co-operation and Development (OECD), GXP, 21 CFR Part 11, European Medicines Agency (EMA) and Food and Drug Administration (FDA) guidelines. • Manuscript writing ability is preferable Proficiency in software like Laboratory Information Management System (LIMS), GraphPad, Adobe etc. Experience: 7+ years of experience in immunoassay laboratory. (CRO experience is preferable). Behavioral Skills: Ability to work independently as well as with team members A strong proactive and independent thinker • Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.

Bioanalyst who will be responsible for high-quality discovery bioanalysis to support preclinical in vitro ADME and in vivo PK studies. LC-MS/MS based bioanalytical techniques to analyse biological samples in support of Drug Discovery projects. Required Candidate profile Around 5-8 years of experience in discovery bioanalysis to support in vitro ADME and pharmacokinetic studies.

learn to perform and manage activities related to technical data compilation and proofing and use of generic documents in compliance with appropriate protocol, Standard Operating Procedure (SOP), regulatory agency guideline, and client requirements in a timely, efficient, and quality manner. Take on DC-related team leader responsibilities, as appropriate (i.e. shipping calendar maintenance, process improvement projects, etc.). Mentor and/or train new DCs. Learn basic study document preparation/maintenance (i.e. prepare standard study protocols from outlines; prepare basic report shells for study directors/SCs to write in). Learn the job duties of the associate DC and more around knowledge of the scheduling tools, etc. Reads and understands study protocols, sample analysis outlines, amendments, regulatory requirements, and SOPs/ as they pertain to basic data retrieval and compilation from electronic systems (i.e. Tox Reporting, etc.). Gains familiarity and understanding in the use and preparation of generic document templates Gains familiarity and understanding in the use and preparation of client-specific requirements as they pertain to client document deliverables (protocols/reports) Works with Study Coordinators to assist in the preparation of study protocols and reports within client-specific requirements and/or the incorporation of contributing information into study reports. Learns to proof shipping paperwork prepared by others. Takes on DC team leader responsibilities and acts as a mentor/trainer for new DCs, as appropriate/applicable Learns and successfully performs report to data QC of at least two study types. Other duties as assigned Experience: Minimum 2 years of experience required