57 Biosimilars Jobs

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

We are looking for a dynamic and experienced professional to lead our Research & Development efforts within the Bioassay function at Biocon Biologics. This role requires a strong scientific foundation, hands-on expertise in bioassay development, and proven leadership capabilities. The ideal candidate will drive innovation, oversee complex R&D projects, mentor junior scientists, and collaborate cross-functionally to support the organizations strategic goals in biopharmaceutical development. Role & responsibilities: Design, development, optimization and qualification of in vitro cell-based assays (reporter gene assays, proliferation assays, Fc effector assays such as ADC, CDC, ADCP, cellular s...

Summary Job Functions: Accountability of project deliverables Key Responsibilities: 1. Act as an anchor point for the project/program and ensure tracking and timely task completion 2. Collaboratively drive execution of projects in partnership with Project Leaders and SMEs from quality, manufacturing, clinical etc. 3. Help ensure that critical decisions are taken in a structured and timely manner with input from appropriate stakeholders. 4. Ensure that critical activities are successfully performed in a timely manner 5. Identify potential resource constraints and propose mitigations 6. Proactively work with R&D, manufacturing to address project requirement 7. Identify critical path activities...

Qualification: MSc. Biotechnology (If Phd then industrial exp can be little less) Keywords: mAbs, Method development, HPLC Thorough knowledge of HPLC based analysis of recombinant proteins. Viz. RP-HPLC, SE-HPLC, glycan analysis etc. Independently design method development of proteins, qualification, transfer following ICH/USP/EP/IP guidelines, including the writing and review of protocols, transfer plans, and reports. Carry out day-to-day analytical work and working in co- ordination with the Cell culture and downstream teams in Biotech R&D. Set-up product related test/ release specifications and analytical protocols Biotech products. Design inhouse /outsource methods for Physico-chemical c...

**Job Description** **Role Overview:** As a team member at Dr. Reddys Laboratories SA, you will be part of a subsidiary of a global pharmaceutical company dedicated to increasing access to affordable and innovative medicines. With a commitment to the principle of "Good Health Cant Wait", the company offers a diverse portfolio of APIs, generics, branded generics, biosimilars, and OTC products across various therapeutic areas such as gastroenterology, cardiology, diabetology, oncology, pain management, and dermatology. Your role will be pivotal in contributing to the company's success in key markets including the USA, India, Russia and the CIS countries, China, Brazil, and Europe. **Key Respon...

Role & responsibilities • Design and execute media/feed screenings and optimizations using ambr250 and bioreactor culture • development, including fed batch and perfusion cell culture processes. • Planning, assigning, and supervising daily operations to ensure proper experiment execution • Experience with aseptic techniques, cell culture in various lab-scale formats, small to medium scale • bioreactors, and cell counting methods and equipments like Cedex, Vi Cell, Osmometer • Handling of Mammalian cell culture using bench top, single use bioreactor and high throughput • systems such as ambr250, WAVE bioreactors and ATF systems. • Excellence in cell culture process development by Fed batch as...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATAM, a...

We are looking for a Regulatory Affairs professional with hands-on experience in biologics/biosimilars registration across Emerging Markets (Middle East, Asia, LATAM, Africa, CIS) regions. The candidate will be responsible for preparing and managing regulatory submissions, tracking country-specific requirements, and coordinating with local affiliates, partners, and health authorities to ensure timely approvals and post-approval compliance. Key Responsibilities: • Prepare, review, and submit regulatory dossiers (CTD/eCTD or country-specific formats) for biosimilars in Emerging Markets. • Maintain up-to-date knowledge of regional regulatory landscapes, including GCC, CIS countries, ASEAN, LATA...

Hiring for Research Associate / Research Executive in Bioassay Lab, specialization in SPR techniques for biosimilar development. Qualification required : M. Sc./ B.Tech/ M.Tech / M. Pharm In Biotechnology Experience : 4-8 yrs in Biosimilars development. Job role: - To perform the experiments planned for techniques such as SPR, ELISA and documentation. - Handling of statistical software such as Softmax Pro, Biacore analysis software and PLA. - Assay development and qualification of receptor binding assay using SPR method- hands on experience on Biacore T200/8K software. - Preparation of SOPs, method development, qualification and similarity report.

Role & responsibilities : Person would be team leader. Person would be responsible for managing 6-10 people from sr. scientist to interns. Candidate would be responsible for planning of work for direct reportees, reviewing of their timesheets. Candidate would be responsible for coordination with cross functional team and AAT team. Person would be responsible for representing AAT in internal meetings Person should be experienced for HPLC, CE, SoloVPE related techniques, trouble shooting , data review and data interpretation Knowledge in characterization methods such as Mass analysis, CD, Flr, DSC, MALS would be an additional advantage. Person should know method qualification for HPLC, CE, Sol...

Job Description: Intas is a leading global pharmaceutical company with a specialization in the development, manufacturing, and marketing of pharmaceutical formulations. The company's mission is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain spanning across the world. With a presence in over 85 countries, including major global markets like North America, Europe, Latin America, and the Asia-Pacific under the brand name Accord Healthcare, Intas has achieved rapid expansion through organic growth and strategic acquisitions. Maintaining high standards of quality reflected in products approved by leading global regulatory agencies such as USFDA, ...

As a highly skilled Regulatory Affairs Professional specializing in biosimilar combination products (drug-device combinations), your main responsibility will be to develop and execute global regulatory strategies for combination product devices. You will play a crucial role in ensuring compliance with evolving regulatory requirements from agencies such as the FDA, EMA, MHRA, and other global health authorities. To excel in this role, you should have a minimum of 5 years of regulatory affairs experience in biosimilars, biologics, or combination product development. Your expertise will be instrumental in providing regulatory guidance on device design, human factors, risk management, and manufa...

Primary Responsibilities: Sales & Revenue Responsible for regional sales & Revenue targets. Achieving revenue targets and KPIs. Business Development. Identify and pursue new business opportunities (Leads / Enquiries) Conduct market research to understand regional trends, customer needs, and competitive landscape. Build and maintain strong relationships with prospective and existing clients. Serve as the primary point of contact for regional clients, ensuring high levels of satisfaction and experience. Conduct client meetings, presentations, and site visits to promote services. Prepare compelling proposals/quotations, client submission, negotiation and securing projects. Sales Performance & R...

Role & responsibilities: The candidate should be an expert in the area of drug product development. He/she should have high level of experience to be called a subject matter expert in concepts of product stability, role of excipients in protein stability, knowledge of higher order structure and its role on product stability The candidate should be well-versed on drug product formulation development. He/she should have knowledge on the concepts of developing a brand new formulation, evaluation of buffer systems, sugar excipients, role of surfactants such as polyols etc. Having experience of developing new formulations for Biosimilar products is a plus The candidate should have experience in r...

Intas is a leading global pharmaceutical company dedicated to the development, manufacturing, and marketing of pharmaceutical formulations. Our mission is to address unmet medical and societal needs through a fully integrated pharmaceutical value chain that spans across the world. With a presence in over 85 countries, including major global markets like North America, Europe, Latin America, and the Asia-Pacific under the brand name Accord Healthcare, Intas has achieved rapid expansion through organic growth and strategic acquisitions. We uphold high standards of quality, with products approved by leading global regulatory agencies such as USFDA, MHRA, and EMA. Our substantial in-house R&D ca...

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Development Specialist( MSAT) for our Biosimilar manufacturing facility( R&D Center) based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process Development for Mammalian Cell culture. Responsible for Scale Up from Pilot study to Bulk Manufacturing. Technology Transfer from R & D to Manufacturing . Qualification and validation of equipment. Exposure to Perfusion process and technique is must. CHO clone development, Clone screening, Shake flask studies, media optimization and bioreactor process development. Candidate Details The Candidate should be a Ph.D...

Job Duties and Scope: Sales & Revenue Growth - Achieve or exceed regional sales targets and KPIs. - Prepare and deliver proposals, quotations, and contract negotiations. - Track and report on sales pipeline, forecasts, and performance metrics . Sales Performance & Reporting - Prepare and present weekly, monthly, and quarterly sales reports - Develop and maintain dashboard presentations for internal reviews and leadership meetings. - Analyse sales data to identify trends, gaps, and opportunities for improvement. Client Relationship Management - Build and maintain strong relationships with key clients, prospects, and industry stakeholders. - Serve as the primary point of contact for regional c...

JOB DESCRIPTION We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: • Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements • Provide regulatory direction on global regulatory requirements to support product development • Ensure all filings are maintained pe...

As an Analyst or Senior Analyst in Bioanalytical Research at Veeda Lifesciences, you will play a crucial role in conducting bioanalytical research activities. This includes method development, validation, and sample analysis utilizing a variety of techniques such as HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. Your responsibilities will also involve developing and validating methods for bioanalysis of biologics and biosimilars in compliance with regulatory requirements, such as those set by the USFDA. Collaboration with cross-functional teams will be essential to ensure the timely delivery of high-quality results. Additionally, you will be tasked with perf...

Roles and Responsibilities: Perform molecular biology activities including: Cloning of gene of interest in plasmids for platform processes In-house vector development cDNA synthesis Plasmid preparation Handling of bacterial cultures and buffer preparations Genetic engineering activities with minimal supervision Carry out cell culture-based activities such as: Transfection, minipool development, and single-cell cloning Clone screening and characterisation Media optimisation for production Early product characterisation as per cell line development plans Utilisation of platform-based and state-of-the-art technologies Develop and optimise new methods/assays to support: Clone development and cha...

Title: Instrumentation and Automation Engineer Qualification: B.E in Electrical & Instrumentation Primary Responsibilities: 1. To attend /or supervise all jobs related to Instrumentation Engineering activities in site. 2. Timely execution of all calibrations of equipments/instruments as per schedule coordination with user. 3. To attend emergency breakdowns of all plant wide machines round the clock as and when required. 4. Maintain the Spare parts of all critical Instruments in site. 5. Timely execution and completion of Validation activities to be done in site. 6. Execution of all In-house Projects in instrumentation and automation in site. 7. Maintain the calibration logs, area /equipment ...

Skill Required: Aseptic operation Upstream/Downstream processing Cell culture/Microbial Knowledge for MAbs/Fermentation/Protein purification Job Description: Proper execution and processing of microbial operations for all commercial, test and validation batches as per production schedule. Proper documentation of batches as per SOPs and written procedures. Ensuring compliance to cGMP in cell culture/microbial area as defined by SOPs of BBM. Preparation & revision of equipment and process related SOPs of cell culture/microbial area. Responsible for general area cleanliness, sanitation and compliance to bio safety policies of cell culture/microbial area. Learn media preparation activities of ce...

Production: Execute production batches, ensure GMP, manage documentation QA: Ensure cGMP, Issuance and retrievals and manage records. QC: Analyze biopharma samples & maintain Documentation R&D: Prepare stocks and buffers, extract proteins & analyze.

Role & responsibilities: Perform commissioning & qualification and validation activities for biopharmaceutical manufacturing facilities in the BU. Responsible for timely preparation, review and approval of URS, DQ, IQ, OQ and PQ protocols, and reports along with operation staff and QA. Responsible for timely preparation, review and approval of other validation documents. Coordinate the Calibration Program, Preventive Maintenance Program and Alarm Management for the biopharmaceutical manufacturing facilities. Responsible for appropriate planning and timely execution along with review and approval of reports. Responsible for robust and optimal practices for maintenance and calibration program ...

Job Description As a part of Dr. Reddys Laboratories Ltd., a leading multinational pharmaceutical company with a global presence, your role is pivotal in accelerating access to affordable and innovative medicines. With a team of over 24,000 employees worldwide, you will contribute towards the collective purpose of ensuring that Good Health Cant Wait. Since our inception in 1984, we have grown exponentially to establish research and development centers, manufacturing facilities, and commercial presence across 66 countries. Our commitment to access, affordability, and innovation is unwavering, driven by deep science, progressive people practices, and robust corporate governance. In the ever-ev...