88 Biosimilars Jobs - Page 3

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...

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 blind...

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...

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 chara...

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 & pro...

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-relat...

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 p...

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...

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 f...

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 d...

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...

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 ...

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 technolog...

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 identifi...

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 s...

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 so...

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...

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 so...

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 so...