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1.0 - 6.0 years
4 - 9 Lacs
Bengaluru
Work from Office
Job Title: Invivo Pharmacology scientist Job Location: Bangalore 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 Specific requirements for this role 1. Experience : 1-9 years 2. Demonstrated Capability: Thorough understanding and practical hands-on experience on Animal models of pain and arthritis 3. Education: Masters in Pharmacology /M.V.Sc Pharmacology Skills and Capabilities Hands-on experience in execution of neuropathic pain and arthritis models of rats and mice. Hands-on experience in handling surgical techniques like SNL (L5 and L6 or L5 alone), CCI, PSNL, SNI in both rats and mice. Hands-on experience in studies involving Diabetic neuropathy, Chemotherapy induced neuropathic pain, CRPS, Osteoarthritis, and Rheumatoid arthritis. Experience in handling & maintenance of instruments like Hargreaves apparatus, Dynamic plantar aesthesiometer, Incapacitance meter Analgesymeter, Von Frey filaments etc, and recording pain readouts using them. Will work independently or in association with senior scientists and other associates in the design and execution of in-vivo efficacy experiments in the relevant therapeutic area. Experience in animals handling (rodents and non-rodents) such as dosing by various routes, blood sampling by various routes, injections by various routes and surgical modalities which includes cannulation etc Associate to provide technical, analysis and reporting outcomes of research for projects in Neuropathic pain area. Ability to work consistently with cross functional teams to achieve common goals & ensure customer satisfaction. Demonstrate consistent ability to communicate with client in well-articulated manner and deliver the results within stipulated timelines. Organizational skills and the ability to work in a highly collaborative environment are required. Prior experience in people management is desired. Extended knowledge and understanding in various components of deliverables from supportive function such as DMPK, Exvivo, Safety assessment & Formulation department
Posted 1 month ago
15.0 - 18.0 years
40 - 45 Lacs
Bengaluru
Work from Office
QUALIFICATIONS Education: Advanced degree in Life Sciences, Pharmacy, or related field Experience: 15+ years in regulatory affairs, including 5+ years leading global teams in biopharmaceuticals. Proven track record in NDAs/BLAs for novel therapies (ophthalmology/metabolic disorders preferred). Expertise in FDA/EMA interactions, including Pre-NDA meetings and Advisory Committees. Skills: Proficiency in clinical trial design, statistical analysis, and regulatory writing. Familiarity with eQMS tools (Veeva, TrackWise) and regulatory intelligence platforms. Global Regulatory Strategy & Submissions Develop and execute regulatory strategies for novel biologics, including pre-IND meetings, orphan drug designations, and accelerated approvals. Lead NDA/MAA submissions for US FDA, EMA, and other agencies, ensuring compliance with ICH guidelines and regional requirements. Oversee clinical trial applications (CTAs/INDs) and provide input on study design, endpoints, and risk mitigation. Team Leadership & Cross-Functional Collaboration Manage a global team of regulatory professionals, fostering expertise in biologics, ophthalmology, and metabolic disorders. Partner with R&D, Clinical Development, and CMC teams to align regulatory plans with development milestones. Compliance & Audit Management Ensure adherence to GCP, GMP, and 21 CFR Part 11 standards during regulatory inspections and audits. Maintain submission timelines using eCTD formats and electronic submission gateways Team & Project Management Mentor QA leaders across sites, fostering a culture of quality and accountability. Design training programs on GMP/GLP updates, inspection readiness, and root cause analysis methodologies. Post-Marketing & Lifecycle Management Direct post-approval regulatory activities, including variations, renewals, and safety updates. Monitor evolving regulations (e.g., FDAs Novel Drug Approvals guidance) and implement proactive compliance measures.
Posted 2 months ago
2.0 - 6.0 years
4 - 9 Lacs
bengaluru
Work from Office
Job Title: Invivo Pharmacology Scientist Job Location: Bangalore NOTE: Therapeutic areas will differ but the roles & responsibilities will remains the same. JOB PURPOSE (Briefly describe the objectives of the job) : The individual must possess knowledge on cancer animal models and various screening methodologies in oncology research area. Understanding of full-cycle drug discovery process is required along with hands-on training in handling various rodents for experimental purposes. KEY RESPONSIBILITIES : Responsible to conduct assigned research projects including experiments with utilizing current concepts and recognized standard techniques. Responsible to set up the experimental designs, analysis of data and concluding from the progress. Record laboratory observations information in lab notebooks, database and document the experimental designs. Responsible for data analysis, perform calculations for the result of the experiment. Summarize the research and communicate result of research to the supervisor. EDUCATIONAL QUALIFICATION / WORK EXPERIENCE : M. Pharm Pharmacology / M. V.Sc / M. Sc biochemistry with 3-6 years of experience TECHNICAL /FUNCTIONAL SKILLS : Hands-on experience in execution of subcutaneous tumor xenograft models, orthotopic xenograft model, metastasis models and syngeneic tumor models. Hands-on experience in studies involving IHC and ELISA readouts Will work independently or in association with senior scientists and other associates in the design and execution of in-vivo efficacy experiments using oncology models. Experience in animals handling (rodents and non-rodents) such as dosing by various routes, bleeding by various routes, injections by various routes and surgical modalities which includes cannulation etc Data recordings and entry into the required formats as per the organizational guidelines. Organizational skills and the ability to work in a highly collaborative environment are required. BEHAVIORAL/MANAGERIAL SKILLS : Good communication skills Excellent interpersonal skills Good team player Strong documentation skills Adhere to organizational data integrity practices and ensure documentation in compliance with ALCOA plus principles. Ensure compliance with environment, health, and safety (EHS) processes defined at organizational level to meet safety goals. 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 accommodation for qualified individuals with disabilities.
Posted Date not available
2.0 - 7.0 years
3 - 5 Lacs
madurai, kolkata, delhi / ncr
Hybrid
We are Hiring Key Account Manager - HCP for a Diabetic Medical device in a global healthcare company, with pioneering products in Diabetic Blood Glucose Monitoring. Head Quarter: Madurai / Trichy, Delhi, Bangalore, Chennai, Jodhpur, Udaipur, Kolkata Job Description: Develop & maintain a high level of customer relationship through consistent high-quality interactions with customers in a given therapy area. Build long-term strategic alliance with a portfolio of accounts to continue to add value and promotes service offerings & develop relationship with Key HCPs, Diabetes Educators & Pharmacies. Identification, mapping, and profiling of HCPs & Diabetes Educators of given geography and therapy area, on an ongoing basis. Ensuring the proper promotion of products, and visibility of POSM materials at Key HCPs Clinics, Diabetes Educators & Pharmacy outlets. At the pharmacy level - Ensure product availability, train the staff, drive visibility, and give demonstration etc. Driving Campaigns under the guideline of the company strategy & regularly tracking stock and sales movement etc. Conduct demand generation through campaign activities as and when required at HCPs/DEs/ Pharmacies. Handling the diabetic center with the proper implementation & monitoring of various stakeholders. Driving SMBG activities through KOLs like- CMEs, Camps & other HCP driven activities. Educational Qualification Any Graduation- ( B.Sc. BA. B.com & B. Pharm ) Language Excellent communication in English & Regional language of the respective state . Should have working experience & knowledge of Diabetic related products If interested, share your resume at resume@aplepharma.com Sapna / Deepika 7019626693, 7015693171 Pl refer Vacancy details to your Friends/ colleagues/ Groups who would be interested in the Job Change.
Posted Date not available
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