No longer accepting applications
ASSOCIATE SCIENTIFIC MANAGER II
Biocon Biologics Limitedindia, India1 day ago
Job descriptionFunctional lead for downstream operations for Biosmilars Planning designing and execution of experiments for process characterization, of DSP operations (Chromatography, reaction, freeze drying, Filtration). Co-ordination for CMC related issues with advanced and Emergin markets requirements, Desiging study protocols and reports for regulatory submissions. Scale down studies, process characterization, process validation and resin re-usability support for manufacturing operations . Risk analysis for DSP process and defining the ranges (MOR and PAR). Compilation, Trending and Statistical analysis of experimental data for evaluation. Comparative data evaluation with Manufacturing batches to define ranges. Manage personal time and resources to realise high performance team Effectively communicate the project updates and timelines Manage and retain critical talents, realizing low attrition and coordinate hiring in case of replacement / expanding teams
Department Details
Role Summary
Technical / functional skills
- Process development, process characterization / Validation knowledge and experience, designing study for regulatory support / dossier filing in advanced and emerging markets.
- Knowledge of DSP and manufacturing operations, trouble shooting, Risk assessment, DoE, Statistical analysis of process data, Regulatory challenges
- Guiding reportees technically and managing their deliverables
- Plan and co-ordinate with other cross functional teams
- Effective communication and presentation skills, excellent technical writing
Key Responsibilities
Key responsibilities :
Educational Qualifications
Required Education Qualification :
Required Experience : 9 - 12 years
Create a job alert for this search
Associate Manager • india, India
Related jobs
![[02 / 11 / 2025] Manager / Sr Manager Regulatory Affairs– US Markets](https://cdn-logos.talent.com/v1/logo/image?feedcode=jobtraffic-in&company_name=Umedica%20Laboratories%20Private%20Limited)
- Promoted
Associate Director - Advanced Analytics
KMK Consulting Inc.Nagpur, IN KMK is a global data analytics and technology consulting company empowering leaders across the Life Sciences industries to make better data-driven decisions.
Our data analytics and software platform...Show moreLast updated: 30+ days ago
- Promoted
Experienced Scientific Writing Author
Fengkai Group Co., LimitedNagpur, IN Taking ownership and responsibility for development (write, review, proofread, and data-check) of high-quality, client-ready scientific, medical, and educational materials like slides, abstracts, p...Show moreLast updated: 30+ days ago
- Promoted
Instructor- Artificial Intelligence
AccredianNagpur, IN We’re looking for a passionate and experienced.This is an exciting opportunity for professionals who enjoy teaching, mentoring, and making complex AI concepts accessible and relevant to business co...Show moreLast updated: 30+ days ago
- Promoted
Market Access Manager
vueverse.Nagpur, IN We are seeking an experienced and strategic.The role requires strong cross-functional collaboration with Commercial, Medical Affairs, Regulatory, and Health Economics teams to develop and execute m...Show moreLast updated: 30+ days ago
- Promoted
Assistant Manager - LMS
EmeritusNagpur, IN Emeritus is committed to teaching the skills of the future by making high-quality education accessible and affordable to individuals, companies, and governments around the world.It does this by col...Show moreLast updated: 18 days ago
- Promoted
ISO Program Manager
MG Environmental Consulting | For Your ISO ComplianceNagpur, IN Compensation - INR 6-8 LPA (per year).MG Environmental Consulting is a fast-growing firm helping businesses nail their compliance goals—whether it's ISO certifications, R2V3, or making recycling op...Show moreLast updated: 30+ days ago
- Promoted
Responsible AI
EXLNagpur, IN We are seeking a highly skilled and principled Responsible AI Evaluator to assess, audit, and ensure the ethical development and deployment of AI models across the enterprise.This role spans tradit...Show moreLast updated: 30+ days ago
- Promoted
Regulatory Affairs Associate I
Teva PharmaceuticalsNagpur, IN Regulatory Affairs Associate I (Regulatory Operation- Regulatory Data Analytics).The role of GRO Regulatory Data Analytics is to : .
Manage Teva’s data in accordance with requirements for xEVPMD in or...Show moreLast updated: 18 days ago
- Promoted
Regulatory / Quality Assurance (Senior Executive / Associate Manager)
Merlin MD Pte LtdNagpur, IN Tips : Provide a summary of the role, what success in the position looks like, and how this role fits into the organization overall.
Participate in the implementation and maintenance of the managemen...Show moreLast updated: 7 days ago
- Promoted
- New!
Manager / Sr Manager Regulatory Affairs– US Markets (02 / 11 / 2025)
Umedica Laboratories Private LimitedNagpur, Maharashtra, India UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.
Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufa...Show moreLast updated: 3 hours ago
- Promoted
Senior Manager R with Statistical Programming
EphicacyNagpur, IN Experience Range 11 – 15 years (minimum 5 years experience of R in SAS Programming).Skill : R Programming Expert with strong SAS expertise.
Technical Roles and Responsibilities.Lead end-to-end clini...Show moreLast updated: 18 days ago
- Promoted
Stem Rater
AceolutionNagpur, IN As a STEM Rater for [Maths / Physics / Chemistry / Biology / Coding / Finance], you will be a crucial contributor to shaping the "brain" of our AI.
Working closely with the STEM Lead and your team, your prima...Show moreLast updated: 30+ days ago
- Promoted
Artificial Intelligence Engineer
Mitchell Martin Inc.Nagpur, IN The Engineer, Artificial Intelligence supports the development and deployment of advanced artificial intelligence solutions.
This role focuses on implementing solutions that leverage Machine Learnin...Show moreLast updated: 30+ days ago
Senior Research Manager / Associate Director (Qualitative),Advisors Research Center
MasterCardIN Mastercard powers economies and empowers people in 200+ countries and territories worldwide.Together with our customers, we’re helping build a sustainable economy where everyone can prosper.We supp...Show moreLast updated: 30+ days ago
- Promoted
- New!
[02 / 11 / 2025] Manager / Sr Manager Regulatory Affairs– US Markets
Umedica Laboratories Private LimitedNagpur, Maharashtra, India UMEDICA is a vertically integrated company engaged in the manufacturing and export of a wide range of finished formulations i.
Tablets, Capsules, Suspensions, Dry Syrups and SVP, at UMEDICA's manufa...Show moreLast updated: 8 hours ago
- Promoted
Associate Data Scientist
v4c.ainagpur, India The Associate Data Scientist supports the development and implementation of data models, focusing on Machine Learning, under the supervision of more experienced scientists, contributing to the team...Show moreLast updated: 11 days ago
- Promoted
Research Associate
AiDASHNagpur, IN AiDASH is making critical infrastructure industries climate-resilient and sustainable with satellites and AI.Using our full-stack SaaS solutions, customers in electric, gas, water utilities, transp...Show moreLast updated: 6 days ago
- Promoted
Subject Matter Expert (SME) - Science (Biology) Assessment Authoring
LearningMateNagpur, IN LearningMate is seeking a qualified and experienced.This role is crucial for developing a robust test bank intended for state testing across multiple US states.
SME-authored non-multiple-choice asse...Show moreLast updated: 11 days ago