7 Bioanalysis Jobs

You will be responsible for providing drug metabolism and pharmacokinetic support for discovery programs. Your main duties will include monitoring Pharmacokinetics studies, supporting bioanalysis, and offering pre-clinical ADME lead optimization support to small molecule Drug Discovery programs across various therapeutic areas. You will be working as a DMPK subject matter lead in multidisciplinary/cross-functional teams to understand the Chemical Structure ADME relationships and design appropriate strategies to enhance the Drug like Properties of the New Chemical Entities. To be successful in this role, you should have 2-5 years of experience in GLP with either an M.Sc. or Ph.D. degree. You should possess expertise in Bioanalysis using LC-MS/MS in both GLP and non-GLP environments. Additionally, you should be capable of leading projects as a DMPK representative, quantifying small molecules using LC-MS/MS, and conducting metabolite identification work on High-resolution mass spectrometry. Qualifications required for this position include an M. Pharm (Pharmacology / Pharmaceutical Analysis) or an M.Sc. (Biochemistry / Pharmaceutical Chemistry).,

Job Title: Invitro BA Scientist Job Location: Bangalore, Hyderabad' About Syngene : Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific services from early discovery to commercial supply. At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines • Overall adherence to safe practices and procedures of oneself and the teams aligned • Contributing to development of procedures, practices and systems that ensures safe operations and compliance to companys integrity & quality standards • Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times. • Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace. • Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self • Compliance to Syngene s quality standards at all times • Hold self and their teams accountable for the achievement of safety goals • Govern and Review safety metrics from time to time Core Purpose of the Role : • To participate in sample processing for PK, ADME assays and handling of LCMS/MS. Ability to adapt to the dynamic team environment • Processing of different matrices samples of PK studies • Optimization of test compounds manually as well as automated on LCMS/MS • Develop methods with the team lead • Independently handling of HPLC for UV based samples analysis. • Documenting the lab note books online and compound management Syngene Values All employees will consistently demonstrate alignment with our core values ' Excellence Integrity Professionalism Experience 3- 10+years Education : Msc/Pharm/Mtech/Phd/ Fresh phd with relevant exp during academics or any postdoc Skills and Capabilities • Expertise in column selection, mobile phase selection, solvent preparations and sample processing techniques such as protein precipitation, liquid-liquid extraction and solid phase extraction is mandatory • Sample processing of New chemical entities from various in-vitro and in-vivo studies executed in Preclinical discovery by using appropriate extraction methods • Should be able to develop and validate LC-MS based qualitative/quantitative methods and apply them in routine analysis • Should be well versed with internet-based literature search and capable of implementing the Learnings as and when required • Candidate is expected to have basic understanding in interpretation of Mass/UV Spectra • Should ensure preventative maintenance and calibration schedules of HPLC & mass spec by coordinating with vendor and support staff • General understanding of Drug metabolism and Pharmacokinetics • Should be able to deliver scientific presentation in departmental journal club and write official Project reports

You are looking for a Study Director - Toxicology position at Syngene in Bangalore. As a Study Director, you will be responsible for overseeing GLP toxicology studies in compliance with global regulatory guidelines. Your role will involve coordinating with cross-functional teams, conducting in-life phases of toxicology studies in various animals, administering doses, collecting blood samples, and ensuring adherence to safety protocols and SOPs. Key Responsibilities: - Serve as a Study Director for in vivo toxicology studies, ensuring scientific, technical, and regulatory compliance - Coordinate with local cross-functional teams for the execution of toxicology studies - Conduct in-life phases of toxicology studies in rats, mice, and rabbits, including dose administration and blood sample collection - Utilize the Pristima data capture system for study documentation - Assist in necropsy activities, blood collection, and electrophysiology studies - Prepare for and participate in IAEC meetings, maintaining necessary documentation - Follow in-house SOPs, coordinate instrument maintenance and calibration, and archive materials from toxicology studies - Perform any other duties assigned by the line manager Requirements: - Experience: 3-6 years in toxicology with a preference for candidates with contract research organization experience - Skills: Good understanding and hands-on experience in toxicology, knowledge of toxicokinetics, pathology, and analytical chemistry - Education: MVSc At Syngene, safety is a top priority, and all employees are expected to adhere to safety guidelines, procedures, and SOPs to ensure a safe working environment. The company values excellence, integrity, and professionalism, and expects all employees to demonstrate these core values consistently. If you meet the specified requirements and are passionate about toxicology, this role at Syngene could be a great fit for you. Join us in our commitment to innovation and scientific excellence in contract research, development, and manufacturing services.,

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