162 Biologics Jobs - Page 2

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...

Role Overview: As the Regional Business Manager (RBM) for GSK's respiratory portfolio in a defined region, you will play a crucial role in driving regional sales performance and ensuring the achievement of business objectives. Your responsibilities will include leading a team of Area Business Managers (ABMs) and Key Account Manager (KAM) to deliver sales targets and enhance brand performance. You will also be required to develop and execute regional business plans in alignment with national strategies and local market dynamics. Monitoring regional performance through data analysis, identifying opportunities, and proactively managing risks will be a key aspect of your role. Key Responsibiliti...

In this vital role, you will be responsible for planning, coordinating, and executing global labeling compliance activities to meet regulatory requirements across multiple regions. Working in close collaboration with cross-functional teamssuch as Regulatory Affairs, Quality, Clinical, Operations, and Supply Chainyou will ensure that labeling processes, documentation, and systems remain accurate and inspection-ready. You will act as a subject matter expert in global labeling requirements, driving continuous improvement initiatives and upholding high-quality standards. Key Responsibilities Global Labeling Coordinate end-to-end labeling changes (including updates, reviews, and approvals) ensuri...

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...

What you will do In this vital role you will provide technical expertise and product leadership to the Product Quality (PQ) organization. As a product support staff in Quality, the Product Quality Specialist has responsibility for working with Product Quality Leaders (PQL), International Distribution Quality, Quality Control, Regulatory, Process Development, Quality Assurance and other groups on projects including support of product specifications, in-process controls, periodic and annual product review, and complaint resolutions. Amgen offers the opportunity to be at the interface between research, global development and manufacturing to ensure that our molecules become medicines. Many of t...

Job Description: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for regulated 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, Spectrophotometry and Colorimetric assays for Biotherapeutics. Major responsibility will be planning and execution of HPLC, UPLC and CE based analysis Skill sets: Knowledge and hands-on experience of different chromatography modes like R...

The Opportunity: To Sell entire Biopharma product portfolio, with emphasis on Small Molecule Market. Close sales on more technical products, working in conjunction with internal functions, Identify and ensuring the process of converting sales opportunities for relevant products from Avantor Biopharma offerings. What we are looking for : Experience: 7-8 years of Biopharma / Pharma / Life science - Sales industry experience required. Education: BS degree in a life science area, or equivalent work experience required. Identify and close new biopharma business. Meeting the budgets for both top and bottom line, ensuring growth in sales figures along with market share by virtue of careful product ...

Hi, We at CIPLA Limited are hiring for Scientific Business Manager role to be based out at Mumbai , Hyderabad , Bangalore , Ahmedabad location. Please find below job details for your reference : Position : Scientific Business Manager Role : Key Accounts Management Location : Mumbai , Hyderabad , Bangalore , Ahmedabad Scientific Business Manager - Immunology Division - Experience in Derma / Rheuma Discuss the products with the KOLs and KBLs and conducting in-depth therapy discussions and explaining the new brands to the customers. Study various updations in the field of the promoted brands. Use various techniques like Therapy discussions, product demonstrations, to covert the doctors. Conduct...

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...

Role Overview: As a Biotechnology Tester, your main role will be to assist in designing test plans, writing, executing, and automating test cases for functional and/or performance testing within the assigned domain. You will perform both guided and exploratory manual test executions, work as a member of the scrum team, and develop strong expertise in the assigned domain area. Additionally, you will be responsible for effectively communicating status, metrics, and issues on a regular basis and assisting in creating high-quality test summary reports. Key Responsibilities: - Design test plans, write, execute, and automate test cases for functional and/or performance testing - Perform both guide...

Job Title: Upstream Manufacturing and Downstream Manufacturing and Job Location: Bangalore We're hiring! We are conducting Walk-in Drive in on 11 2025 () for multiple openings in Biopharmaceutical Operations. Interview Location - Hyderabad & : 11th Oct 2025, 09:00 AM to 12:00 PM - : Syngene Scientific Solution Ltd. Knowledge Square Park - 9000, Plot No.7, Survey No.542, MN Park, Synergy Square 2, Genome Valley, Kolthur Shamirpet, Medchal, Hyderabad, Telangana 500078 Please find below the JD and share your confirmation for Walkin About Syngene: Syngene (www.syngeneintl.com) is an innovation-led contract research, development and manufacturing organization offering integrated scientific servic...

Role & responsibilities Ensure timely reporting of deviations, appropriate investigations to identify root cause or most probable root cause and proposal & implementation of appropriate CAPA to prevent reoccurrence. Perform the manufacturing investigations for OOS results and Customer Complaints to identify root cause or most probable root cause and facilitate proposal & implementation of appropriate CAPA to prevent reoccurrence. Participate in the audits and inspections as SME for deviation management and manufacturing investigations. Ensure timely proposal and implementation of appropriate CAPA for any audit findings. Perform timely tracking of Operational and Compliance Metrics for Manufa...

As an Upstream Manufacturing Documentation at Syngene, your role will involve leading the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. You will provide expert leadership overseeing strategic and day-to-day activities in upstream process development of complex novel biologics. Your responsibilities will include overseeing technology transfer to support scale-up and GMP manufacturing, building strong relationships with CMOs, designing and executing risk-based process characterization studies, scaling up processes, preparing technology transfer protocols, collaborating with other teams, liaising with regulatory affair...

- Analytical biochemist with experience in routine protein analysis such as antibodies, bispecific antibodies, Fc fusion proteins. - LC MS, ELISA, SDS PAGE Western blotting Required Candidate profile Complex protein analytical method development, method qualification, analytical method transfer. Antibody Drug Conjugate analysis using HPLC methods, deeper understanding of LC MS-

Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robust...

New position for the night shift to monitor/handle the fermenters and perform intermediate testing of the cultures. Skills Required : Upstream, Microbiology, fermentation, Microscopy, Able to work in shift Roles and Responsibilities : 1) Operate fermenters and related equipment as per Standard Operating Procedures. 2) In-process sampling and real-time data entry in logbooks/annexures. 3) To perform microbial testings/Assays/Microscopic Observation. 4) Parameter Monitoring and compilation of data. 5) Adherence to Good Laboratory Practices, Good Documentation Practices and Safety. 6) Work in shifts (Days/Night).

Job Description: 1 . Hands on Experience in regulatory submissions preferably for Blood products and Biologics. 2. Review/Submission of applications for new products Manufacturing licenses and renewals. 3. Experience on procedures for application of new drugs (NOC's and Test licenses). 4. Monitoring and ensuring allp certificates (COPPs, GMP, GLP, WHO-GMP and FSC Production Capacity and Performance Certificate) renewals and approvals up to date. 5. Review of Tender certificate. 6. Co-ordinate with Drug control authority personnel for License approvals. 7. Review of Dossiers. 8. Submission of Samples and Documents to NIB, Noida for testing. 9. Updation of the National and international legisl...

Dear Candidate, WE ARE HIRING Department: - Production- DS Designation: - Dy Manager / Manager Qualification: - Preferably Post Graduation in Science Experience: - 15+ Years Age: - Between 35- 40Years Mandatory: - Should come in all shifts, including Night shifts Role: Shift-in-charge for entire DS floor Job Description: > Strong Functional knowledge of DS Biologics (Chromatography and related purification experience protein/ Insulin handling experience preferable). Capable of handling large teams as we have around 45 members in each shift, around 50% of contractual staff. Strong administration / team management capabilities to streamline GMP across the floor. Monitoring the efficiency of em...

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725

Dear Candidate , we are hiring for the Position Jr Executive .(Instrumentation,Hematology,Activity,Potency Based Assays,Bio chemical group) 1.Candidate have good hands on experience in HPLC, electroscopic test methods. 2.should be able to handle liquid chromatography instrument and relevant 21 CFR softwares 3.should be able to handle ELISA Reader ,microscope,basic QC Instruments . 4.candidate should have good hands experience in colorimetric ,spectrophotometric. 5. should be have a idea on GLP compliance requirements. for more details please reach out Venkat -9381915043 /Manasa - 9502434725