25 Biosimilars Jobs

Desired Experience Experience of biostatistics in regulated markets Interacted with regulatory agencies (FDA/EMA/PMDA) Experience of biosimilar product development Knowledge of statistical models, meta-analysis, regression, longitudinal data analysis Knowledge of using relevant software including PASS, SAS, SPSS, R Job Description Prepare scientifically sound statistical design for clinical trials Design clinical trials for biosimilars for global requirements (FDA/EMA/PMDA) Perform meta-analysis and calculate sample size Prepare statistical justifications for agency interactions (FDA/EMA/PMDA) Review and provide inputs to statistical sections of clinical trial protocol Plan and perform blinded sample size re-estimation and interim analysis Review and provide inputs to statistical analysis plan and CRF Review tables, listings, figures and clinical study reports Collaborate with internal and external stakeholders (CROs) to resolve issues around statistics Respond to agency queries on issues related to biostatistics Qualification : MSc., PhD in Biostatistics Experience : 10-15 years' experience in a Pharma / CRO

Role & responsibilities 1. Act as a Principal Investigator / Co-investigator in phase-1 studies, Biosimilar and BA/BE studies in all therapeutic area as well as various kind of formulation. 2. Feasibility assessment of different molecules as per request from sponsors. 3. Conducted complex BA/BE study at hospital site as Principal Investigator. 4. Involved in Audit/Inspection handling and Projects conducted as Principal Investigator have been audited and cleared by different regulatory. 5. Leading and guiding the Research Staff as Team Lead. 6. Prepare and review protocols for clinical studies 7. Ensure compliance to protocol, SOPs and Regulatory requirements 8. Communicate IEC related issues to all concerned 9. Coordinate with Project Coordinators for all project related matters 10. Monitor and manage adverse events 11. Coordinate with panel of consultants to seek medical opinion as and when required 12. Ensure timely response to QA findings 13. Interact with sponsors on medical related matters 14. Handle safety related issues and ensure appropriate communication 15. Prepare and review reports for clinical studies 16. Overall supervision of screening and check-in activities 17. Write and review related SOPs 18. Contribute towards scientific development of the organization 19. Support clinical trial group 20. Handle medical confidential report and case management 21. Help maintain and update all the systems and SOPs in the department 22. Train the staff on CPR, GCP and related guidelines and all departmental and relevant SOPs. 23. Any other responsibilities as assigned by the Head of the Department

Job Title: Research Associate Department/Function: BRL Reporting To: DGM Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working Job Summary: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for all markets. Deliverables involves, but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities. Responsible for independent planning and execution of experiments. Techniques include, but not limited to Chromatography, Electrophoresis, Spectrophotometric-Colorimetric assays and Higher order characterization for Biotherapeutics. Required Skillsets: Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc is required. Preferred to have some working knowledge of biosimilars. The following are considered strong assets: Manufacturing industry experience, JAVA stacks experience. Maintain effective and cooperative working relationships with administrators, staff, users, project consultants. Good to have : Integration with Non SAP systems via RestAPI, SOAP API , SFTP etc. Experience Required: Experience of working on biotherapeutic proteins like Cytokines, Fc fusion peptides/proteins and/or Monoclonal antibodies is required Method Development and/or routine analytical support experience with biosimilars is a must Understanding of analytical deliverables involving CQA, QTPP, Biosimilarity, Forced degradation studies, Specifications setting, etc. is preferred. Accountability: To perform assigned analytical activities by following established systems and procedures. To maintain target dates for analytical activities. To maintain data integrity during analysis. Preparation and review of reports and contribution in troubleshooting efforts required for Instrumentation Communicate effectively with other team members and teams regarding the analytical data. Education: Min. Qualification Required - M.Sc. / M.Tech. - Biotechnology / Microbiology Experience: Minimum 6 months- 2 years

Sales of Filtration Products from leading Filtration brands in Pharmaceuticals (API & Formulation), Biopharma (Mabs, Vaccines, Other Biosimilars), Oil & Gas industries, Ultrapure Water, Digital Inks & Printers Visiting Industrial across the assigned region for pitching High Performance Industrial products for various applications. The candidate will undergo training and will be meeting key decision makers in the industry and do value selling. Candidate will hold Technical/Commercial discussions with R&D, Manufacturing, Production providing them product benefits, commercial offers, negotiations, order execution followed by payment collection. The candidate will adhere to the visit plans & provide regular visit report to Manager. Candidate will be empowered with data for Sales forecasting Monthly, Quarterly and Annually based on sales history and new developments. All new developments will be uploaded in Sales Funnel for Customer mapping and keeping Track of competitors activities in the region. Candidate will partner with the Sales Manager to meet and exceed sales targets and developing new accounts to grow the business. Role & responsibilities Preferred candidate profile

Job Description : Experience in operation and calibration of (HRMS/qTOF). Experience on Intact Mass Analysis, peptide Mapping, Impurity profiling, unknown impurity structure identification, sequencing of Peptides, biosimilars and small molecules. Independent Data analysis of characterization experiments. Experience in impurity profiling of GLP1 analog peptide API and formulation products. Preparation of summary reports, SOPs, Protocols and Reports Transportation & Canteen Facilities Available

#hiring. Know anyone who might be interested? Veeda Lifesciences (Veeda Clinical Research) is seeking a passionate "Characterization Specialist" Experience: with 3 to 6 yrs Location: Bangalore Interested candidates can share an updated CV to mahendra.t3705@veedalifesciences.com JOB DESCRIPTION: Role & responsibilities: Experiments Execution of planned experiments/studies using physico-chemical methods. Develop advanced LC-MS-based methodologies for the characterization of protein and peptide products. Design and implement integrated analytical strategies by combining chromatography and mass spectrometry techniques. These strategies aim to qualitatively and quantitatively assess product-related variants and impurities. This includes the development of innovative sample preparation methods, with a focus on LC-MS, CEX-MS, and SEC-MS, native MS, HDX as well as the characterization of innovator product batches sourced from various geographical regions to establish a comprehensive quality target profile. Lead the development of sophisticated analytical workflows, including multi-attribute methods for post-translational modifications (PTMs), sequence variant analysis, profiling of host cell proteins (HCPs), disulfide bond analysis and shuffling, cell culture metabolite analysis, and glycan profiling. Data Generation Sample preparation, data acquisition, data analysis/processing of HPLC/UPLC/LCMS/HRMS/CE based experiments/studies. Preferably on Thermo/Waters/Sciex platforms. Interpretations Scientific interpretations of processed data (manual/software-driven). Reporting Reporting of scientific data into suitable/approved report formats. Data Integrity Adherence to data integrity principles (ALOCA++) and quality compliance, as applicable. Documentation Preparation and up-keep of documents such as standard operating procedures, instrument/equipment related documents on qualification/validation, as applicable. Instrumentation Co-ordinate for maintaining the operational status of respective instrument/equipment with vendors/OEM. Ad-hoc Studies Execute ad-hoc studies/experiments/activities based on organizational needs/priorities. Knowledge Upskill with advancements in physico-chemical and/or structural characterization through literature surveys/webinars/conferences/symposiums. Conferences Participate in scientific meetings/interactions and present scientific data in form of posters/oral presentations/publications.

Greetings from Sri Krishna Pharma We are hiring Quality Control for our API , Formulation (OSD ) and Nutra .Biotech Units Roles and Responsibilities Conduct quality control tests on OSD (Oral Solid Dose) and API (Active Pharmaceutical Ingredient) products using various instruments such as HPLC, GC, UV-Vis Spectrophotometer, Polarimeter, Karl Fischer Titrator, pH Meter, Finished Products Analyzer, Melting Point apparatus, Auto titrator, IR Spectrometer, Potentiometer. Ensure compliance with cGMP guidelines during testing procedures. Maintain accurate records of test results and reports. Collaborate with cross-functional teams to resolve any issues related to product quality or manufacturing processes. Participate in continuous improvement initiatives to enhance laboratory operations. if interested please share your resumes to jayakishore.gollapalli@srikrishnapharma.com

Role & responsibilities: Formulation and drug product development for biosimilar products with special focus on insulin and insulin analogues Design and execute the experiments for pre-formulation and formulation process development for biosimilars and optimization ensuring its stability and efficacy Conduct stability studies as per guidelines and Perform analytical testing using advanced analytical instruments such as SEC-HPLC, RP-HPLC etc. Document experimental data and preparation of SOPs, protocols and Reports Preferred candidate profile: Must have basic understanding of container closure system like vial, cartridge, PFS etc. Must be familiar with regulatory requirements (USFDA, EMA) for biologics development Must have operational knowledge of HPLC/UPLC systems for protein characterization and impurity profiling Must have good understanding of fill finish manufacturing operation

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Good team player. Good written and oral communication Role & responsibilities Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

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.

What you will do Let’s do this. Let’s change the world. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC submission execution for Amgen products across phases of development, modality, and countries. In this vital role you will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing submission content plans for CMC submissions including, CMC IND/CTAs and amendments, new marketing applications, facility registration and renewals, postmarket supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC submissions and related communications in the document management system Initiate and maintain CMC product timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams What we expect of you We are all different, yet we all use our unique contributions to serve patients. Basic Qualifications: Doctorate degree and 1 to 3 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industryOR Master’s degree and 4 to 6 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 6 to 8 years of experience in manufacture, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: Experience managing or overing staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now for a career that defies imagination Objects in your future are closer than they appear. Join us. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

Job Description (Head R&D) 1) To build and direct a team for the development of processes for the commercial manufacture of plasma derived therapeutic proteins. The responsibilities will include the following; a) Identification of plasma derived products that can be developed for commercialisation. b) Review of published literature including patents to understand the existing product, process and formulation. c) Plan the development of scalable processes for the purification and formulation of proteins from human blood plasma. d) Plan for process validation, packaging material development, stability studies, alternate vendor development studies. e) Coordinate training, scale-up and technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.

Greetings from Kashiv Biosciences!!!! We are looking for Validation and QMS Engineer for our Engineering Team in our Biosimilar Manufacturing facility based out of Ahmedabad. Below are the roles and Responsibilities. Roles and Responsibilities: Responsible for Engineering compliance , Validation and QMS activity. , Timely escalation of any challenge bottle necks pertaining to engineering compliance to the management (site leadership team) to ensure proper planning and solutions. Representing as a Subject Matter Export of Engineering department in front of regulatory auditors. Responsible for engineering investigations pertaining to equipment failures and ensure for proper root cause identification and CAPA effectiveness. Responsible for technical agreements with vendors who have work at Plant premises. Responsible for preparing and review the master list of equipment, instrument along with the preventive maintenance & calibration scheduled. Responsible for change control/deviation management/CAPA Through Track wise management System. Facing the Regulatory, Customer, Internal Audits and preparation of compliance. SOPs and Protocols Training for the new personnel and refreshment training for existing team members. Co-ordination with CFT line Production, QC & QA department to execute any engineering documentation related works. Candidate Details The candidate should be from Pharma industry only having exposure to Parenteral/ Injectables. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to equipment qualification, Validation and QMS . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process for Microbial Cell culture and Mammalian Cell culture. Should have exposure on various F ermentation techniques. Qualification and validation of equipment. Exposure to Perfusion process and technique is must. Candidate Details The candidate should have worked in Biosimilars Upstream production(Microbial/ Mammalian Culture) Exposure to Regulatory Audit is Must. Should be aware of QMS Documentation. The candidate should have good communication skills. Interested candidates Please share the resumes at my manan.hathi@Kashivindia.com

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: General Manager Business Development & Portfolio( Emerging Markets) Job Requisitions No : 12956 Job Description Skill Required Manage & ensure Budget activity in alignment with the Finance Teams, providing the annual Budget File based on existing Portfolio and upcoming registrations, Manage project milestones, prioritization, defining timelines & tracking and reporting progress with R&D Qualification Required MBA Marketing Roles and Responsibilites Establish relationships with development companies specialized in injectables & oral generics, added value generics, specialty pharma products Identify gaps in the existing portfolio, evaluate complimentary products for portfolio Manage & ensure highly organized deal negotiation process involving preparation of non-binding offers, carrying out due diligence process, finalizing binding offers and then contract negotiation process engaging all key stakeholders within the organization Plan and execute end-to-end activities including product development, registration, launch and actively involved in implementing pre/ post marketing activities, Create financial business cases of the projects after consulting with EM teams for inputs on current market, forecast & market shares, Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Essential Relevant skills / Industry experience Preferred exposure to CVS/CNS/Biologics/Biosimilars marketing, Experience in as similar role with strong experience of In-licensing management with pharmaceutical prescription drugs in the EM/US/EU market 15-20 yearsexperience cross BD / Sales / Marketing / Portfolio / Strategy with minimum 5-7 yearsexperience of In-licensing Relevant professional / Educational background Good business acumen, Impressive & demonstrated career record in a similar position at a similar level, Strong analytical and problem-solving ability, Ability to influence at a senior level, both internally and externally, Good IT skills (Word, Excel, PowerPoint and Outlook) High on energy and enthusiastic about achieving high levels of excellence, Any Other Requirements (If Any) Previous experience managing a P&L and understanding of business financial objectives, Cross-cultural organizational awareness Skilled relationship builder, pragmatic, strong but subtle influencing style, Credibility and authority to provide strong leadership in a dynamic culture, Commercially aware with good analytical and problem-solving skills, Flexible interpersonal skills to build strong internal networks at all levels, win trust and break down barriers quickly Compensation / Reward As per Industry Standard Location: Ahmedabad, GJ, IN, 380054 Travel: 50% 75% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 10 Apr 2025

Open Positions: Officer / Executive / Sr Executive Quality Assurance & Quality Control : Analytical Skill on HPLC, Electrophoresis, Microbiology, Document Review, IPQA, Quality Systems, GMP Compliance, QA-QMS Biosimilars Manufacturing: Downstream (Operation of Chromatography systems) & Upstream (Handling of Single use and Stainless-steel bioreactors) Experience: 2 to 10 years of relevant experience in Biopharmaceutical Qualification: B Sc / B. Pharm/B Tech / M Sc in Microbiology / Biotechnology / Chemistry/M. Pharm Date : 01st June 2025, Sunday Time : 08:30 AM to 06:00 PM (Registration will be closed by 12:00 PM) Venue : Hotel Pride , 5, University Rd, Narveer Tanaji Wadi, Shivajinagar, Pune, Maharashtra 411005, India Note: All positions are based out at Pune, Gotawade.

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Senior Research Scientist ADL Job Requisitions No : 12504 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Associate BDL Job Requisitions No : 13267 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Research Associate ADL Job Requisitions No : 12908 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

About Intas Intas is a leading global pharmaceutical company specializing in the development, manufacturing, and marketing of pharmaceutical formulations The mission of the company is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world, Through its subsidiaries, the International presence of Intas includes the following countries: over 85 worldwide, with some of the more important global markets like North America, Europe, Latin America, and the Asia-Pacific under the well-known brand name Accord Healthcare The rapid expansion has been due to organic growth and strategic acquisitions alone, vindicating its position in some of the important major pharmaceutical markets across the world, Intas follows high standards of quality, as reflected by products approved for leading global regulatory agencies including USFDA, MHRA, and EMA Substantial in-house R&D capability, along with the beginning of a focus on highly advanced areas like Biosimilars and New Chemical Entities-Intas continues to push the frontiers of excellence in healthcare, At Intas, our success is fundamentally built on the strength of our people Our ongoing commitment is to attract and retain the best talent in the industry while fostering an empowering environment that encourages innovation and excellence This approach ensures that every employee plays a meaningful role in driving both the companys growth and advancements in global healthcare, Job Title: Associate Scientist BDL Job Requisitions No : 13268 Job Description Purpose of Job Skill Required Roles and Responsibilites Qualification Required Competencies Intas Action Oriented Intas Customer Focus Intas Dealing with Ambiguity Intas Problem Solving Intas Time Management Relevant Skills / Industry Experience Relevant professional / Educational background Any Other Requirements (If Any) Compensation / Reward Location: Ahmedabad, GJ, IN, 382213 Travel: 0% Life at Intas Pharmaceuticals For over three decades, Intas has thrived due to the exceptional talent of its people Our growth is fueled by a dynamic environment that nurtures individual potential while fostering collaboration and collective success We believe that when diverse skills and perspectives unite under a shared purpose and value system, we can achieve remarkable outcomes, driving innovation and excellence across the pharmaceutical landscape, Date: 11 Apr 2025

Job description: Location: Hyderabad, Corporate Office Job Type: Full-Time Reporting Line: Reports to AVP Marketing Position: Individual Contributor Drive team engagement, professional growth, and skills enhancement. 2. Brand Strategy & Execution Directly manage select brands, overseeing positioning, differentiation, and lifecycle strategies. Guide team members in their respective brand responsibilities while ensuring execution excellence. Provide strategic direction to affiliate marketing teams and senior leadership. 3. Market Insights & Competitive Intelligence Analyze market trends, competitive landscape, and customer insights to refine regional strategies. Ensure data-driven decision-making and provide market-specific recommendations. 4. Product Launches & Lifecycle Management Lead new product launches, balancing regional alignment with local adaptation. Drive sustained brand growth through lifecycle management initiatives. 5. Cross-Functional & Stakeholder Collaboration Work closely with Medical, Market Access, Commercial Excellence, and Regulatory teams. Align regional marketing plans with affiliates, distributors, and local teams. Partner with senior leadership to identify growth opportunities and address challenges. 6. Cultural Sensitivity & Market Adaptation Ensure strategies are tailored for diverse Southeast Asian markets, considering cultural nuances. Adapt communication and branding to resonate with different healthcare environments. Strong leadership and team management capabilities, with experience in managing diverse teams. Ability to work across cultures, ensuring strategies are adaptable to different countries. Expertise in brand strategy, product launches, and lifecycle management - for oncology Solid Tumour and haematology range of products. Strong analytical, strategic thinking, and problem-solving abilities. Excellent communication, negotiation, and stakeholder engagement skills. Education: Undergraduate or Masters degree in Life Sciences, Pharmacy, Marketing, or Business Administration. Experience: 15+ years of experience in the Pharmaceutical Industry, with at least 8-10 years in marketing in oncology product marketing. Minimum 3-5 years of experience in team leadership and people management. International marketing experience preferred, with a focus on brand strategy and market expansion. Preferred Attributes: Experience leading teams in matrix organizations. Strong understanding of multicultural healthcare dynamics in Asia. Ability to drive marketing excellence and execution discipline. Interested Kindly Send me your Updated Resume to Pitchireddy.t@hetero.com Regards Pitchireddy T

About The Role : Amgen is a leading human therapeutics company in the biotechnology industry. For more than 40 years, the company has tapped the power of scientific discovery and innovation to advance the practice of medicine. As a Fortune 500 company serving millions of patients, Amgen continues to be an entrepreneurial, science-driven enterprise dedicated to helping people fight serious illness. Regulatory Affairs, Chemistry, Manufacturing and Controls (RA CMC) facilitates product development and global registration by developing and executing regulatory strategies and managing effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Amgen’s CMC submission execution team, Regulatory Optimization of Tactical and Strategic Support (ROOTS2), is seeking to expand its capacity in India. The ROOTS2 team supports CMC and/or Device submission execution for Amgen products across phases of development, modality, and countries. The ROOTS2 staff member will interface with the Amgen Global, Site, Biosimilars, and/or Device RA CMC teams for specific strategies or activities that impact a product. The ROOTS2 staff member will be responsible for varying levels of product support, including leading projects, based upon their experience level. Additional job responsibilities include: Lead submission for annual reports, facility registrations, facility renewals, and product renewals Potential to oversee or manage staff Act as a primary point of contact for specific submission execution or annual reporting tasks, including but not limited to, developing, documenting and maintaining process documents, training and onboarding new staff, and/or coordinating with impacted cross functional teams Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions Preparing and/or over seeing preparation of submission content plans for CMC submissions including, CMC IND/CTAs and amendments, Investigational Device Exemption (IDE)/Performance Study Application (PSA)/ Clinical Investigation Application (CIA), new marketing applications, facility registration and renewals, post-market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications Coordination, preparation, collection and/or legalization of CMC country specific documents Document and archive CMC and/or Device submissions and related communications in the document management system Initiate and maintain CMC product and/or Device timelines at the direction of product lead Interface with the regulatory operations team Train staff on select CMC procedures and systems Provide report status of activities and projects to teams and department Participate in cross-functional special project teams Basic Qualifications: Doctorate degree OR Master’s degree and 5 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry OR Bachelor’s degree and 7 years of minimum experience in manufacturing, QA/QC, or regulatory CMC in the Pharmaceutical/Biotechnology industry Preferred Qualifications: BS degree in Life Science Experience managing or hovering staff members Experience in manufacture, Process Development, Quality Assurance, Quality Control, or Analytical development Experience in IVD, Device or Combination Product regulatory submission process Regulatory CMC specific knowledge and experience Mature project management and organizational skills Strong and effective oral and written communication skills Experience in Veeva Vault platforms

Role & responsibilities Understanding business of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Understand the analytical requirements of Biologics, Biosimilars, Vaccines, fusion proteins, peptides Develop and implement strategic sales plans to achieve revenue targets within the biopharmaceutical sector. Identify and pursue new business opportunities with biopharma clients Build and maintain strong relationships with existing clients, understanding their needs and ensuring exceptional customer satisfaction. Collaborate with cross-functional teams including technical experts, marketing, and operations to tailor solutions that meet client requirements. Keep abreast of industry trends, market dynamics, and competitor activities to identify potential opportunities and threats. Prepare and deliver presentations, proposals, and contract negotiations to secure new business partnerships. Provide regular updates and reports on sales performance, market trends, and client feedback to senior management. Ability to work independently and collaboratively in a fast-paced, dynamic environment. Demonstrated ability to think strategically and execute tactical sales plans to drive revenue growth. Preferred candidate profile communication, negotiation, and presentation skills Strong understanding of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Willingness to travel as required to meet with clients and attend industry events.

Roles & Responsibility: Perform method development, method validation and study sample analysis under supervision of Project Manager (s). Passaging of cells as well as performing cell based assays while maintaining aseptic conditions in cell culture laboratory. Perform ELISA & other Ligand Binding Assay according to study protocol guidelines and/or SOPs Processing of specimens to support the clinical studies. Preparation of required reagents and solvents. Preparation of SOP(s) and work instruction. Following GLP, GDP, GCLP & other good practices. Desirable candidate: MSc BioTech/ Biochemistry/ Microbiology or BTech Biotech fresher. 0-1 year of relevant experience will be preferable. Sound knowledge on Immunology. Good communication skills, analytical skills and team coordination.