162 Biologics Jobs - Page 3

Dear Candidate , we are hiring for QC Jr Executive ,Down stream process executives & Operators. Open Positions-50 Down Stream Process Executives & Operators Required • Qualification: Bsc/Msc/ITI/B Pharmacy Experience in handling the following Equipment 1 Chromatography column and system handling. 2 Column Packing (BPG And Chromoflow) 3 TFF System 4 Centrifuge system 5 Filtration, Filter Integrity,Buffer Preparation,CIP_SIP PRODUCTION-DS M Pharmacy/Diploma/B tech/Any Degree 6 Expertise in documentation QMS/GMP Compliance / Process Awareness Biologics Company's only Preferable. • Experience: 2 to 6 years in Total Downstream CTC :up to 5.0 LPA. IMMEDIATE JOINERS ARE PREFERABLE" Interested candi...

DEAR CANDIDATE , WE ARE HIRING! LET'S JOIN OUR TEAM NOW! Department: R&D Position: Research Trainee / Research Associate Preferred Qualification: M.Sc. Biotechnology / M.Sc. Biochemistry Preferred candidate: Male Preferred Experience: 2 to 3 years of experience Should have good documentation skills and knowledge of GDP, GMP, GLP. Should have basic knowledge about proteins and protein purification. Should be a good team player with good interpersonal skills. Job description: Perform R&D related documentation like SOP preparation, data management and data analysis. Perform routine laboratory procedures, including buffer preparation, gel electrophoresis, western blot. Operation and maintenance ...

Dear Candidate , we are hiring for Fresher for the position Microbiologist . Job Description: Department:- Microbiology Exp: 2.0 yrs to 3.0 yrs Des:- Jr Executive-Executive Qua:-MSc Microbiology Only Male Candidates Preferable Bio burden testing of in process samples as per the specification. BET testing of water samples, in-process samples, semi-finished and finished samples as per the specification. Sterility testing of finished product. Responsible to perform the MLT testing for raw materials and water samples. Maintenance and handling of Endotoxin indicators and biological indicators. Experience on culture maintenance and VITEK2 compact system To perform the method validations for MLT, B...

Dear all, Hiring for operators....... Location: Perundurai Qualification:ITI,DIPLOMA,DEGREE,12TH Job role: ETP Operations Exp - 2-8 Years Working Hours - 8 hours in 3 shifts. (Rotational Shifts) No Food No Transport Salary - 2.5 LPA - 4 LPA interested candidate can send resume @m.venkatesh@manpower.co.in regards, Manpower Group

You are being sought after to take on the role of Regulatory Affairs Lead/ Project Manager, joining a dynamic team that values passionate regulatory professionals. Your main responsibilities will include managing regulatory projects for Pharmaceuticals, Biologics, Medical Devices, and other products in Global Markets. You will be expected to plan and prepare regulatory project plans/submission strategies, lead regulatory submissions, manage interactions with Health Authorities across multiple regions, and provide clear guidance to cross-functional teams by identifying regulatory gaps and assessing risks. Additionally, you will work closely with Regional Regulatory Experts, act as the primary...

Join Amgens Mission of Serving Patients At Amgen, if you feel like youre part of something bigger, its because you are Our shared mission?to serve patients living with serious illnesses?drives all that we do Since 1980, weve helped pioneer the world of biotech in our fight against the worlds toughest diseases With our focus on four therapeutic areas Oncology, Inflammation, General Medicine, and Rare Diseasewe reach millions of patients each year As a member of the Amgen team, youll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives Our award-winning culture is collaborative, innova...

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...

You will be working as an Asst Manager / Manager in the Biologics function of USV Private Limited in the Regulatory Affairs department specifically focusing on Clinical Trials for the EU and US markets. Your role will involve the following key responsibilities: - Developing Biosimilar Clinical Development Strategy, focusing on clinical trials and injectables for EU and US markets. - Designing and developing clinical protocols for Biosimilar Clinical trials, ensuring review and finalization for EU and US markets. - Handling Biosimilar Clinical Trial Applications, providing an overview of clinical study conduct, reviewing Clinical Study reports, and finalizing them for EU and US markets. - Aut...

Your role at PCI as part of the Batch File Review Team will involve compiling and reviewing batch documents across various process types such as OSD, Sterile, Biologics, Cell Therapy, and Gene Therapy. You will collaborate closely with internal and external stakeholders, preparing documentation for Quality Person (QP) review, coordinating corrections, and ensuring compliance with regulatory requirements. This position offers a diverse range of responsibilities and serves as an ideal foundation for those considering a future career as a QP. Key Responsibilities: - Compile and review batch documents, ensuring accuracy and completeness prior to QP review. - Collaborate with site personnel to ad...

As part of the renowned organization, Piramal Group, you will be joining Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) dedicated to providing comprehensive solutions throughout the drug life cycle. PPS operates on a global scale with integrated facilities in North America, Europe, and Asia, offering services such as drug discovery solutions, process & pharmaceutical development, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Specializing in the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products, PPS is...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products • Collaboration with partners to develop and execute global regulatory activities • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier p...

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...

Role & responsibilities Job Description: Position : Area Sales Manager-Team handling (IC role) Segment: Bio logics/ Bio Similar- Derma segment Please find below the JD. B. Pharma. / B.Sc. / B. Tech. -Biotechnology graduates / or ANY 30 years of age with 4+ years of Experience in Derma Biologics / Biosimilar industry. Dynamic Individuals : Energetic, self-motivated, and goal-oriented professionals. Excellent Communicators : Strong interpersonal and communication skills. Healthcare Enthusiasts : Passion for the pharmaceutical industry and a commitment to excellence. Team Players : Ability to work collaboratively in a fast-paced environment. Roles & Responsibilities: Build and maintain strong C...

Job Responsibilities: Overall Responsibilities: 1. Compiling all the relevant information necessary to prepare best regulatory dossier (M1 to M5) for registration of a new vaccine or a license update in all concerned row countries including WHO Prequalification. 2. Developing and maintaining the Regulatory Dossier Module 1 to Module 5 keeping the document updated throughout the life of the project/product. Ensuring the coordination with the different areas concerned: Clinical Development, Product Development, Marketing and CMC related functions. 3. Participating and performing change control assessment (CCRs) of any necessary changes and implementation plan with a global view for the impacte...

Biological E. Limited invites experienced, dynamic and self-motivated candidates with 2 to 14 years of experience for the below positions at its Vaccine Business, Shamirpet, Hyderabad. RESEARCH AND DEVELOPMENT R&D Upstream Processing Designation: Sr. Executive/Executive Qualification: B. Pharm/ M. Pharm and B. Tech/ M. Tech/ M. Sc (Lifesciences) Preparation and maintenance of Research cell banks, Master cell banks, and working cell banks for different projects, Strong experience in day-to-day laboratory operation, e.g. using equipment, aseptic techniques, preparing media/solutions Knowledge of planning and executing the scale-up of fermentation processes, mathematical skills, specifically wi...

Designation: Executive/Senior Officer/ Officer Department: Manufacturing - Antigens (Production) Educational Qualification: M.Sc/ B.Sc/ B. Pharmacy/ B.Tech (Biotechnology)/ Diploma (Any Life Sciences background) Experience: 1-9 years Location: Biological E. Limited (Vaccine Division), Kolthur, Hyderabad Roles & Responsibilities: Execution of Upstream & Downstream production batches. Focus on timely execution, to ensure that the process is carried out as per GMP and batch timelines. To execute planned Upstream & Downstream activities to ensure high degree of confidence that the process is delivering a product that meets its target specifications. Routine monitoring of the equipment, Facility ...

As a Senior Analyst in Bioanalytical Research at Veeda Lifesciences, your role involves conducting bioanalytical research activities including method development, validation, and sample analysis using techniques like HPLC, GC, mass spectrometry, chromatography, spectrophotometry, and polarimeter. You will be responsible for developing and validating methods for bioanalysis of biologics and biosimilars in compliance with regulatory requirements such as USFDA. Collaboration with cross-functional teams is key to ensuring the timely delivery of high-quality results. Additionally, you will perform stability testing of biological products under various conditions and troubleshoot issues related to...

Job Summary: Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products including technical and Regulatory aspects. Responsible for: • Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio • Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products • Collaboration with partners to develop and execute global regulatory activities • DMF preparations, review of changes and routine updates to Global Regulatory Agencies • Dossier p...

Job Description ADL Skills Required: 1. Chromatographic skills like SEC, IEX, HIC, RP, etc with operation of HPLC, UPLC equipments. 2. N-Glycan analysis is preferred and higher order structure analysis experience will be advantage. 3. Electrophoresis skills like Capillary electrophoresis (cIEF, CE-SDS NR & R, CE-LIF) etc. 4. Work experience on analytical method development and validation for biotherapeutic products. 5. Experience on documentation preparations like SOPs, MOA, MDR, etc. Computer literacy in Microsoft office and softwares related to critical equipments. Roles and responsibilities: 1. Responsible for timely analytical deliverables of Biotherapeutic projects involving QTPP and Pr...

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

About the Company Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming...

About Immuneel Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy. Working at Immuneel promises the excitement of an agile startup on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and ...

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...

As the Senior Product Manager, Biologics at the U.S. Pharmacopeial Convention (USP) in India, you will play a crucial role in managing the existing Biologics portfolio of Reference Standards and Analytical Reference materials. Your responsibilities will include contributing to enhancing the global quality and supply of Biologics Drugs in collaboration with various stakeholders such as biopharmaceutical developers, manufacturers, and regulatory agencies. You will oversee the lifecycle management of current USP standards, ensuring they address the needs and challenges faced by developers and manufacturers in different therapeutic areas. Collaborating with cross-functional teams, you will be in...

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...