5 Mabs Jobs

Core Purpose of the Role: Responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs Role Accountabilities: Shall develop and validate cell-based assays and binding assays (ELISA), especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems with bioassay methods Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies. Experience in Qualification and Validation of cell-based bioassays Broad knowledge on analysis of cell-based assays to derive relative potency softwares (such as Softmax Pro and PLA) Basic cell culture technics and hands-on experience in maintaining of mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines). Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation Shall prepare the raw datasheets, protocols, reports, and SOPs Handling of QMS (Incidents, deviations, change controls, etc.) for GMP activities Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects Shall adhere to the procedure of GxP/GMP/Safety and as per the procedure defined in the internal standard operation procedure Must have good hold on MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs t communicate with clients/external users situated overseas Commitment to safety

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 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

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.

Hiring professionals with expertise in the analytical method development and characterization of biologic molecules. Hands-on experience with analytical techniques such as HPLC, UPLC, Capillary Electrophoresis, and Mass Spectrometry is required. Experience in method development, qualification, and transfer is highly desired. Guiding and mentoring juniors is a plus. Preferred candidate profile