6 Monoclonal Antibodies Jobs

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 different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

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 technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.

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 skills. Interested candidates Please share the resumes at my manan.hathi@Kashivindia.com

Job Description: Cell Culture Specialist Monoclonal Antibodies Production Position: Cell Culture -Scientist Department: Medipath- Cell culture -RND Location: [Baddi, Himachal Pradesh] Reporting To: [ Cell Culture Senior Scientist] Job Summary We are seeking a highly skilled and experienced Cell Culture Specialist to join our monoclonal antibodies team. The ideal candidate will have 3-4 years of hands-on experience in cell culture techniques, with a strong background in biotechnology. This role involves maintaining and optimizing cell lines, scaling up production processes, and ensuring high- quality monoclonal antibody yields. Key Responsibilities 1. Cell Culture Management: Maintain and expand mammalian cell lines used in monoclonal antibody production. Monitor cell health, viability, and productivity through routine checks and assays. 2. Process Optimization: Optimize media composition, feeding strategies, and environmental conditions to maximize antibody yields. Implement scalable production processes for large-scale monoclonal antibody manufacturing. 3. Quality Control: Conduct regular contamination testing and ensure cell line integrity. Perform routine analytical assays, including protein quantification and activity testing. 4. Documentation and Compliance: Maintain accurate and detailed records of all cell culture processes and experiments. Adhere to GMP/GLP standards and ensure compliance with regulatory requirements. 5. Equipment Handling and Maintenance: Operate and maintain bioreactors, incubators, and other cell culture equipment. Perform calibration and troubleshooting of equipment as needed. 6. Cross-Functional Collaboration: Work closely with upstream and downstream teams to streamline production workflows. Provide technical support and training to junior team members. Required Qualifications • Bachelor’s degree in Biotechnology or a related field. • 3-4 years of proven experience in mammalian cell culture for monoclonal antibody production. • Strong knowledge of aseptic techniques and cell culture process optimization. • Familiarity with bioreactor operations and scale-up processes. • Experience with analytical techniques such as ELISA, SDS-PAGE, and Western Blot is a plus. Preferred Skills • Excellent problem-solving and troubleshooting abilities. • Strong organizational and documentation skills. • Ability to work in a fast-paced, team-oriented environment. • Familiarity with regulatory and quality guidelines, including GMP/GLP. What We Offer • Competitive salary and benefits package. • Opportunities for professional growth and development. • A collaborative and innovative work environment.

GMP Downstream role KEY RESPONSIBILITIES Carries out the Cell and Gene Therapy manufacturing in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs) Executes manufacturing operations in clean room, following cGMP requirements and wearing sterile gowning Prepares equipment and raw materials for manufacturing Performs (preparation and execution) aseptic process simulation Executes all steps outlined in the batch records Reads and fulfils in real time production batch records and equipment logbooks Perform and assures the cleaning state and routinary maintenance of the manufacturing equipment Immediately reports any deviations occurred during manufacturing execution or preparation, errors in the documentation or any potential matter relevant for the correct completion of the manufacturing to the management Carries out the work in compliance with company Safety Policies Prepares for production (engineering batch, full scale batch, clinical batch) and identification of batch specific requirements Reports any accidents, incidents and injuries immediately notifying any hazards, unsafe procedures, or conditions in the workplace Keep up to date by participating in training courses and opportunities Participates at writing and revision of SOPs and Manufacturing documents Participate to the quality investigation from production side Participates at Regulatory Authorities audits for aspects pertaining the role Supports the activities for periodic qualification of clean room interacting with QA and engineering Is involved in process-related meetings Collaborates with Process Development team to bring manufacturing process in GMP Experience and Knowledge Experience in clean room environments Previous experience in downstream purification is mandatory Experience in manufacturing of any or all - plasmids, viral vectors, or Biologics GMP upstream is essential Experience of any or all tasks including performing filtration, chromatography and associated techniques is essential Good communication skills with the ability to liaise with internal and external stakeholders Showing initiative in executing plans and delivering objectives. Problem solving mindset. Strong team player

Role & responsibilities 1. Handling of Facility, equipment and utility qualification activities. 2. Preparation and review of Quality SOPs. 3. Handling of Vendor management. 4. Good knowledge in ISPE, EMA, FDA 21 CFR & ICH guidelines. 5. Handling of QMS elements. 6. Handling of equipment breakdowns. 7. Experience in HVAC, EMS and BMS qualification activities. 8. Having process knowledge is an added advantage. Department: Biotech Development Quality Assurance(DQA) Experience: 2-7 years Qualification: M.Sc, B.Pharma & M.Pharma Preferably from Biotech Companies. Please share resume to below mentation mail id dinesh.baratam@msnlabs.com