8 Bioreactor Jobs

Greetings from Kashiv Biosciences!!! We are looking for Process Equipment Engineer for our Biosimilar Manufacturing Plant Based out of Ahmedabad. Below are the further details. Experience 15 - 20 Years of Process Equipment Maintenance Education: B.E/ B. Tech( Mechanical/ Electrical/ Electronics/ Instrumentation) Roles & Responsibilities Responsible for the Plant Maintenance activity of DS (Drug Substance) section equipment's such as Fermenters, Process vessels, CIP vessels, batch centrifuges, TFF systems, Merck chromatography columns, Filter press . Responsible for the Plant Maintenance activity of DP (Drug Product) section equipment's Such as Vial Washing machine, Vial filling & Cap sealing machine, Laminar Air Flows, DPBs, Autoclave, Labelling machine etc. Responsible for Maintaining of biologics MFG units (Cell Culture), Filling Facility (DP),QC,WH and R&D facility . Maintenance of Biologics manufacturing facility (Mammalian) including Development and QC lab(Microbiology). Responsible for QMS Documentation validation and new Equipment Qualification. Required Instruments Exposure : Bioreactor Fermenter Media, Buffer & CIP vessel Continuous Centrifuge Continues Kill system Homogenizer Chrome system TFF system Autoclave Chromatography Candidate Details: The candidate should be from Biopharma industry having exposure Drug Substance and Drug product Maintenance. The candidate should have exposure to regulatory Audits. The candidate should be aware of GDP/ GMP Process. The candidate should have exposure to new equipment qualification & QMS as well . The candidate should have good communication skills. Interested candidate please share the resume on my mail id manan.hathi@kashivindia.com Regards HR Team Kashiv Biosciences

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: 1-7 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 and utilities for GMP compliance Execution of documentation activities of liaison with QA and QC for GMP compliance. Participate and execute compliance of validation/ Qualification documents. Participate in execution the various compliance from the different cross functional team for QMS compliance Interested candidates may walk-in with an updated CV, latest increment letter and the last 3 months' pay slips on Friday, 04th Jul'25 from 10:00 AM to 12:00 PM at Biological E. Limited (Vaccine Division). Address: Plot No.1, Phase-II, Near MN Park, Genome Valley, Kolthur (V), Shameerpet (M), Dt. Medchal Malkajgiri, Hyderabad Land Mark - A road opposite to Honey burg Resort on Karimnagar Highway. (Beside Venkateshwara Swamy Temple) Interested candidates unable to attend the walk-in can send in their CVs by mention subject as Applying for Department Name to "HR.Intern4@biologicale.com"

Location: IIT-Bombay/Vikhroli Bioprocess Engineer- Upstream & Downstream R&D Day-to-day responsibilities include: Operating bench-scale bioreactor systems Perform reactor sample analysis (wet lab, GC, pH, moisture, ash) Evaluate reactor performance (conversion efficiency, mass balance, optimization) Operating and analyzing biological and chemical systems in batch and continuous mode. Compile and analyze data from process development, troubleshooting, and summarize in high-quality reports Assist the founding team in technology advancement Nice to have: 1. 2 -5 years of experience with operating a bench-scale bioreactor and wet-lab skills 2. Experience with analysis- pH, moisture, ash, and gas chromatography 3. Experience with operating bench and pilot scale distillation apparatus 4. Operating downstream process equipments 5. Experience with chemicals process design and simulation using ASPEN plus 6, Experience with process modeling and simulation using SuperPro Designer Must Have: 2-5 years of relevant experience BS / MS / PhD in relevant engineering or science fields (biotechnology, chemical, microbiology, biochemical, chemistry) with keen interest in waste to value technology development. Job Type: Full-time Salary: 15,000.00 - 50,000.00 per month Ability to commute/relocate: Mumbai, Maharashtra: Reliably commute to IIT Bombay, Powai & Vikhroli (Required)

Role & responsibilities Strategizing the Biosimilar process development based on CHO & other mammalian cells lines for developing non-infringing Upstream process. Understanding the cell Lines, cell culture & Bioreactor process based biotherapeutic proteins development towards submission in India & various regulated countries. Good knowledge of Cell line development & cell line characterization. Understanding developmental requirements for India, ROW & regulated market (Phase-I & III) and their fulfilment during development of respective geographies. Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Designing and conducting the process characterization for upstream development Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analysing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. Capable of leading a team of Scientist & Sr. Scientist for day-to-day Cell culture works at lab and active, productive coordination with cell culture and analytical groups for timely completion of project. Oversee and coordinate work performance at Production plant or any 3rd party Manufacturing unit Support to commercialization activities (assistance for tech transfer, process validation studies, manufacturing investigation, trend evaluation & troubleshooting) Literature survey, Patents identification & writing research papers Preparing CMC data package, URS, Qualifications, Process development report, BMR & implementation of Quality system. Engaging himself / herself in frequent scientific discussions, constant learner & responsible for targeted deliverables. Preferred candidate profile Candidate should be well versed with latest developments in Upstream related Instruments, Cell culture & Bioreactor process for implementing techniques towards developing the robust process in time bound manner. The candidate should be a very good team player and comfortably connect inter & intra departmental teammates with an expedited productive outcome. Need to demonstrate and continue implementing good documentation practices with data traceability. Should inculcate a scientific acumen in team members and exhibit a good leadership. A clear and convincing oral and written communication in English is desired. He / She should have the good working knowledge of MS office, handling statistical software and related analytical tools. Principal Scientist, preferably PhD /post docs from abroad having Bioprocess cell culture experience.

Role & responsibilities Planning and execution of experiments as part of process development, Upstream activities at shake flask and Bioreactor stages for recombinant molecules. Responsible for Media & Feed formulation & preparation, components role verification & utilization based on spent media analysis for overall process improvement Responsible for Process scale up & scale down operation at various scales of Bioreactors. Responsible for analysing scientific research data using statistical software to analyse trends and patterns to help interpretation & establish the robust process. To carry out day-to-day Cell culture works with minimal guidance, sample preparation, productive coordination with cell culture and analytical groups for completion of assigned work. Maintain records and complete documentation of all the performed experiments. Compiling and interpreting experimental data of experiments in an efficient and timely manner. Visiting manufacturing facility for carrying out various R&D & process validation batches in co-ordination with Production team. Preparing SOPs, Qualification documents, AMCs, Maintaining Logbooks & LNBs. CMC data package, URS, Qualifications, Process development report, BMR & implementation of Quality system. Preferred candidate profile Must have experience in Upstream Process Development Must have experience of working on Bioreactors Must have experience in Mammalian cell culture Good knowledge and understanding of proteins. Sound knowledge on Good Laboratory Practices (GLP). Hands-on experience on protein purification technique.

Key Responsibilities: To execute cell culture experiments, reviewing and analyzing data and independently interpreting experimental results for various projects. To scale up the batches considering parameters from shake flasks to Bioreactor scale. Manage day-to-day cell culture work and able to troubleshoot and to resolve any technical challenges. To conduct DOE & provide in-house design space by optimizing scientific methods & troubleshooting efficiently to ensure high Quality & production standards. Media preparation, Cryovial freezing-thaw work & Harvest clarification. Co-ordinating and managing URS based technical discussions with various vendors for Instrumentation & services related requirement. Overseeing the maintenance of all cell culture related instruments and controlled area in consultation with Maintenance dept and vendors as per the specification. Compile R&D reports, SOPs, MMFs, BMRs to comply internal specification & for any in-house audit. Additional Requirement: Good knowledge of MS office and other software. Commitment to work on weekend / holidays in case of lab work requirements. Willingness to visit Production plant & to execute work as per requirement basis.

Strategic: Work towards continues improvements in automation & instrumentation to bring down the cost and technology advancement. Plant upgradation works planning, execution on Periodical basis. Able to visualize & plan the activity related to overall Project execution. Plan & execute the work towards the management goals. Able to handle DS and DP equipment’s Updated & aware of GAMP5, cGMP, statutory guidelines & standards requirements for automation and instrumentation. Plan for implementation of Automation layers Aware & update the latest software related to Automation & Instrumentation, DP, DS. Operational: Monitor the overall activity of Automation and Instrumentation activities. Plant level Automation and instrumentation breakdown diagnostics and maintenance for DP, DS, QC, EMS, BMS & Utilities. Support to Automation Layers implementation and validation. Calibration management including planning, execution, documentation and control for the plant level. Automation to support for upstream and downstream processing of MAbs/therapeutic proteins such as microbial, cell culture, chromatography, TFF, blast freezing, CIP/ SIP etc. Technical site support for CCTV, Access control, Door interlock. However main responsibility of maintaining & trouble shooting, planning & execution rests with facility management department. Coordinate with EHS team for trouble shooting of Fire alarm, PAS, VESDA & Gas suppression system. Technical site support for IT team for Data & Internet connectivity. However, main responsibility of maintaining & trouble shooting, planning & execution rests with IT department. Preparation/Review of SOP, Preventive Maintenance schedule/planner, Documentation etc. Coordination with user departments & plan for Preventive/Breakdown/ Calibration maintenance. Ensure smooth operation of plant & machinery to avoid breakdowns & production loss. And Coordination with user departments & plan for Preventive/Breakdown maintenance. Monitoring of outsource agency for plant operation. Review & coordinate for finalization of agreements. Preparation/Review/Training of SOP, Preventive Maintenance, Break down Maintenance, Schedule, Planning. Support Audit & follow Statutory Compliance. Review & approval of P & ID along with control & function layout drawings and electrical drawings. Prepare/ Review/ Execution of SLIA, URS, DQ, QRM, CLIA, FAT, SAT, IQ, OQ & Support for PQ. Monitoring of outcome agency for plant operation. Review & coordinate for finalization of agreements. Preparation and execution of QMS documents in the department. Goal setting to team members & annual review. Providing the same to the department head for review & approval. People: Shift scheduling, Manpower planning, reporting & Shift operations. Contract / Service provider Manpower/activities planning, reporting.

Position Overview:This position involves in optimizing and scale-up fermentation-based processes for nutraceutical manufacturing.Essential Duties and Responsibilities:Prepare media according to established protocolsCalibration of data loggers and handling instruments used in the upstream processesUtilize your knowledge of fermentation principles to improve microbial cultures and optimize fermentation Knowledge of seed transfer into fermentation vessels5. Prepare detailed technical reports, batch records, and other documentation in compliance with regulatory guidelines and company procedures - upstreamCollaborate effectively with cross-functional teams Knowledge of downstream processing techniques and purification of microbial products