88 Biosimilars Jobs

Key Responsibilities: 1. Regulatory Strategy & Planning • Develop and implement regional regulatory strategies for biosimilar product registrations in the Middle East, North Africa, CIS, and Non-EEA countries. • Ensure alignment with global regulatory strategy and business priorities. • Conduct regulatory risk assessment and provide mitigation strategies during planning and execution. 2. Dossier Preparation & Submission • Oversee the preparation, review, and submission of high-quality dossiers (CTD/eCTD format) for new marketing authorizations, renewals, and variations. • Coordinate with CMC, non-clinical, clinical, and labeling teams to gather required documentation. • Ensure submission tim...

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 over 85 countries 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 im...

You will be working as the DGM-Intl. Mktg. (Bus. Development) at Intas, a leading global pharmaceutical company with a mission to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world. Intas maintains high standards of quality with products approved by leading global regulatory agencies including USFDA, MHRA, and EMA. **Role Overview:** As the DGM-Intl. Mktg. (Bus. Development) at Intas, your primary responsibility will be to develop and expand international markets for the company's pharmaceutical formulations. You will play a crucial role in driving the growth and advancements in global healthcare by identifying business op...

THERANYM BIOLOGICS PRIVATE LIMITED Title: Job Responsibilities/Descriptions Qualification: B.E/Diploma in Electrical & Position: Assistant Manager/Dy.Manager- Instrumentation 1No electronics/Instrumentation with 7/10 Years exp . Job Responsibilities/Descriptions 1. Experience in Bio-pharmaceutical Instrumentation Projects / Maintenance 2. At least 5 years handling Experience on Biosimilar / Vaccines Manufacturing Facilities or Consulting firms. 3. Hands on Experience on BMS / EMS /UMS systems installation, commissioning &qualification 4. Hands on Experience on Bio Process Equipment Instrumentation. 5. Preparation, Review of Process Instruments technical specifications. 6. Responsible for rev...

As the Senior Manager of Patient Safety at ADVANZ PHARMA, your primary responsibility will be to monitor and manage all aspects of updating Reference Safety Documents for all ADVANZ PHARMA products globally. You will need to maintain these documents in accordance with applicable guidelines, ensuring a global process along with region-specific processes for writing and managing reference safety documents like CCDS and SmPC. Your experience in writing reference safety documents for various types of drugs will be crucial for this role. **Key Responsibilities:** - Act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives, and upholding high-qualit...

Position Summary: The Executive Regulatory Affairs (Biosimilars) will be responsible for the preparation, review, and submission of high-quality CMC documentation to support regulatory filings in the US, Europe, and other global markets. The role involves cross-functional collaboration, drafting of eCTD modules, and ensuring compliance with international regulatory requirements for biosimilar products. Role & responsibilities Review and finalize CMC (Chemistry, Manufacturing, and Controls) documents for US (FDA) and European (EMA) regulatory submissions. Draft, compile, and review eCTD sections , ensuring compliance with current regulatory and technical standards. Author and review key regul...

Role & responsibilities Perform Mass Spectrometry (LC-MS/MS) analysis for structural and physio-chemical characterization of peptides/proteins (Intact mass, Peptide mapping, Sequencing) Operate and maintain high-resolution mass spectrometer (Q-TOF/Orbitrap/Relevant Instruments) Support characterization studies for biologics - Insulin and Insulin Analogues, Therapeutic proteins and Biosimilars Ensure proper compliance in line with GLP norms Preferred candidate profile Proficient in advanced proteomic analysis methods. Proficient in impurity analysis, top-down and bottom up proteomics Experience of using various advanced structural characterization methods (CE, CD, DSC, DLS, IR, AUC) would be ...

Role & responsibilities Responsible for upstream manufacturing process support, data acquisition, and trending. To manage statistical analysis of manufacturing batches data using statistical software like Minitab, etc. Lead the upstream team in troubleshooting and process related deviation investigations activities to identify the root cause followed by providing an effective CAPA. Plan, evaluate and manage the technology transfer of new / existing products from sending unit (R&D) to receiving unit (Manufacturing). To collaborate and communicate regularly with R&D teams in execution of experimental runs and any other scale down experiments to support manufacturing process changes/improvement...

In this role, you will act as a lead in developing client accounts and generating new projects in Real World Evidence (RWE) and throughout the organization. Your responsibilities will include ensuring the timely completion of deliverables for assigned projects, leading multiple client engagements simultaneously, and participating in special projects to enhance Prescient's capabilities. You will also be involved in proposal development and other business development activities to generate new client contacts and opportunities for the company. Key Responsibilities: - Lead and execute RWE projects to high standards - Establish and maintain valuable, long-term client relationships while overseei...

We are looking for an Analyst to join our LifeScience and Healthcare Products business group in Noida . This is an amazing opportunity to be a member of a talented and vibrant Biopharma Insights team. The team consists of about 100 people working across different locations globally . We have a great skill set in market research and assessment and we would love to speak with you if you have skills in this area . About You experience, education, skills, and accomplishments Masters degree in pharmacy/life sciences/pharmaceutical management is required . Relevant experience of 3-4 years of in the biopharma, healthcare, market research, or financial sector is required . Ex perience in working on ...

Job Summary: Responsible for supporting and leading process development and scale-up activities for recombinant therapeutic proteins. Plays a key role in executing upstream operations, managing project timelines, contributing to regulatory submissions, and ensuring compliance with quality and data integrity standards. Collaborates cross-functionally to ensure successful manufacturing of toxicology and clinical batches. Support end-to-end development and execution of upstream processes for recombinant therapeutic proteins. Act as project lead for select molecules under guidance, coordinating with cross-functional teams. Perform small to pilot-scale fermentation or cell culture experiments for...

Job Summary: The Associate Scientist in the Process Analytics lab is responsible for timely analytical support to Upstream Process Development (UPD), Downstream Process Development (DSP), and Cell Line Development (CLD) teams for biotherapeutic projects. The role involves performing various biochemical and analytical techniques to support process characterization and optimization activities. Key Responsibilities: Execute experiments using techniques such as colorimetric/spectrophotometric assays (e.g., BCA, Bradford, OD280), chromatographic methods (HPLC, UPLC SEC, IEX, RP, HIC), and electrophoretic techniques (IEF, SDS-PAGE, Western blotting, Capillary Electrophoresis). Independently plan a...

Job Summary Responsible for preparing and submitting regulatory filings to support the registration and lifecycle management of recombinant products in global markets. Ensures regulatory compliance by collaborating with cross-functional teams and maintaining up-to-date regulatory documentation and systems. Key Responsibilities Prepare and compile regulatory submissions including IND, IMPD, CTD dossiers, and briefing books for global product registrations. Update dossiers covering Administrative, CMC, and Clinical information; respond to regulatory agency queries in a timely manner. Track and maintain regulatory registrations and product lifecycle data to ensure compliance with global regulat...

Job Summary The Project Management Specialist is responsible for tracking and supporting the execution of cross-functional R&D and manufacturing projects. This role involves acting as the central coordination point between functions such as quality, manufacturing, and clinical, ensuring that deliverables are met on time and within scope. The individual will support structured decision-making, mitigate resource constraints, and provide regular updates to leadership. Key Responsibilities Act as the anchor point for assigned projects/programs and monitor progress against plans. Drive execution in collaboration with Project Leaders and Subject Matter Experts (SMEs) across quality, manufacturing,...

Job Summary Execute downstream process development for biosimilar projects, including chromatography, filtration, tech transfer, scale-up, and data documentation, ensuring compliance with quality and regulatory standards. Key Responsibilities Perform downstream processing using AKTA chromatography (SEC, IEX, HIC, RP), filtration (TFF), virus validation, and cleaning validation. Operate, troubleshoot, and optimize AKTA systems and downstream unit operations. Support tech transfer, process scale-up, and characterization using QbD principles. Prepare and review protocols, reports, and regulatory documents. Collaborate cross-functionally with UPD, ADL, DPD, QA, and manufacturing teams. Ensure ac...

Job Summary: Responsible for executing molecular biology and mammalian cell culture techniques to support cell line development activities including vector construction, transfection, clone selection, and assay development. Ensures compliance with GLP/GDP and timely documentation of all work. Key Responsibilities: Perform molecular biology tasks: gene cloning, cDNA synthesis, plasmid prep, buffer prep, and bacterial culture handling. Execute cell culture work: transfection, minipool generation, cell cloning, media optimization, and early product characterization. Support development and optimization of clone evaluation assays and molecular/protein biology techniques. Maintain lab records (LN...

Job Summary: The ADL Scientist is responsible for delivering high-quality analytical data to support biotherapeutic product development. The role involves hands-on execution of various analytical techniques including chromatography and electrophoresis, with a focus on method development, qualification, and process support, ensuring compliance with regulatory and scientific standards. Key Responsibilities: Timely execution of analytical deliverables for biotherapeutic projects involving QTPP, process support, method development, qualification, and transfer. Perform benchwork using diverse analytical techniques including colorimetric/spectrophotometric assays, chromatographic tests (SEC, IEX, ...

Greetings from Kashiv Biosciences!!!! We are looking for Qualification, 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 , Equipment Qualification, 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...

Role Overview: You should have a qualification of M.Pharm in Pharmacology along with 2-5 years of relevant experience. Your role will involve having preferred CT operational exposure in Biosimilars and small molecules from the Sponsor/CRO platform. Key Responsibilities: - Possess a qualification of M.Pharm in Pharmacology - Have 2-5 years of relevant experience - Demonstrate CT operational exposure in Biosimilars and small molecules from the Sponsor/CRO platform - Preferred candidate would be female Qualifications Required: - M.Pharm in Pharmacology - 2-5 years of relevant experience - CT operational exposure in Biosimilars and small molecules - Female candidate preferred,

Join a globally recognized CRO and be part of cutting-edge research and work with advanced technologies and contribute to high-impact pharmaceutical innovation Department: Analytical Services (Biologics) Position: Senior Chemist/Junior Research Associate Location: Hyerabad Qualifications: M.Sc. / M. Pharm / M.Sc. in Biotechnology or Equivalent Qualification 1-3 years of relevant experience in pharmaceutical industry or CRO environment. Proficiency in mass spectrometry and chromatographic techniques for biologics. Knowledge of cGMP/GLP and instrument qualification processes. Strong communication and independent working skills. Roles and Responsibilities Develop analytical methods and for biol...

Role & responsibilities Please find below JD for position in Research & Development at Intas Plasma Fractionation Centre based in Ahmedabad dealing in Plasma Protein Products: - Characterization of plasma proteins by various physicochemical methods - Responsible for stability sample analysis by different methods and its data management - Analytical Method Qualification and Analytical Technology transfer - Method Development & Troubleshooting - Instruments Handling/ Techniques: SDS-Page , HPLC, GC, IEF and Western blot - Reference standard qualification, instrument & micropipette calibration - Responsible for document preparation/review of LPs, MOA, MQP, MQR,TTD and documentation of related a...

Role Overview: You will be a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations). Your primary responsibility will involve developing and executing global regulatory strategies for combination product devices. Your focus will be on ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. Key Responsibilities: - Provide regulatory guidance on device design, human factors, risk management, and manufacturing considerations. - Lead and coordinate regulatory submissions for biosimilar combination products, including IND, BLA, and EU MDR filings. - E...

As a Regulatory Affairs Specialist at Kashiv India, your role will involve leading or supporting filing activities for Biosimilars, NCEs, and ANDAs in emerging markets such as Japan, Canada, ANZ. Your responsibilities will include: - Handling query responses, providing audit support, and assisting in lifecycle management of the products. - Providing regulatory support for the filing of IND/CTA to various regulatory agencies. - Ensuring the maintenance of IND/CTA by submitting protocol amendments, adding investigators, obtaining EC approvals, submitting SAE reports, and preparing quarterly/annual reports. To qualify for this position, you should meet the following criteria: - Education: Maste...

Greetings from Kashiv Biosciences!!! We are looking for Upstream Production Specialist for our Biosimilar manufacturing facility based out of Ahmedabad . Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Production for Mammalian Cell culture. Should have exposure on various Fermentation techniques and Single use Bio reactors. Qualification and validation of equipment. Exposure to Perfusion process and technique is must. Candidate Details The candidate should have worked in Biosimilars Upstream production (Mammalian Culture) for atleast 10 Years and exposure to Perfusion technology is must. The candidate should have worked on Single use bioreactors...

About the Role We are seeking a visionary Business Head to lead our India operations, driving strategic growth, operational excellence, and market expansion across the biopharma landscape. This is a high-impact leadership role suited for a seasoned professional with deep industry insight, commercial acumen, and a passion for transformative healthcare. Key Responsibilities Spearhead India business strategy, aligning with global objectives and local market dynamics Lead cross-functional teams across sales, marketing, supply chain, and regulatory affairs Drive revenue growth, profitability, and market share in critical care and plasma therapy segments Cultivate key stakeholder relationships acr...