23 Upstream Processing Jobs

Role & responsibilities: Primary Responsibilities: Operate bioreactors (1L, 10L, 100L) under sterile conditions, ensuring zero contamination and successful batch trials. Prepare media, feeds, and buffers with high accuracy and maintain sterility via filtration/autoclave. Perform sterile handling of feed additives, media, and filtration processes. Carry out CIP and SIP of bioreactors to ensure readiness for use at any time. Ensure availability and calibration of equipment and instruments; troubleshoot any breakdowns to maintain workflow. Execute downstream processing techniques, including HPLC (affinity, AEX, CEX, and SEC chromatography). Perform protein purification and estimation techniques such as protein assays/SDS-PAGE, ELISA/radioimmunoassay, and Western blotting. Plan, schedule, and execute day-to-day activities without errors. Apply technical knowledge of mass transfer coefficients, process parameter measurements, and method validation. Train and mentor junior team members, fostering collaboration to achieve project targets. Collect, analyze, and plot experimental data for comparative studies. Secondary Responsibilities: Maintain a sufficient stock of chemicals, glassware, materials, and consumables to ensure uninterrupted workflow. Arrange procurement of required items within timelines to avoid process delays. Manage email communications and plan tasks accordingly; clarify technical or process-related queries with superiors before execution. Support team members and foster a positive, collaborative work environment.

Role & responsibilities Execution of manufacturing activities. Upstream Processing of in house and contract research projects Preparation of SOP/BMR for Upstream process. Fermentation of different Recombinant Proteins. Planning of raw material /consumables management for production campaign. Follow cGMP practices during the manufacturing activity and operations associated activities with QA and QC. Compliance to cGMP in all the manufacturing activity, and timely closure of executed documents and batch records. Preferred candidate profile Knowledge in handling and troubleshooting Fermentation process & process scale up Pre-seed, Seed / Inoculum development. Instrument handling & Buffer/Reagent preparation - pH meter, Spectrophotometer, Batch centrifuge, continuous centrifuge, LAF, shaker incubator, Autoclave, Microscope, SDS Page Experience in cGMP facility, GDP & Audits

Designation: Senior Executive/ 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 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 Thursday, 21st Aug'25, & Friday, 22nd Aug'25 from 10:00 AM to 02:00 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"

As a Senior Executive in the Upstream Manufacturing Department located in Bengaluru, India, you will be responsible for various tasks related to Mammalian Cell Culture Upstream Processing. With a required educational qualification of BTech/MTech/MSc and 6-8 years of relevant experience, you will play a crucial role in the manufacturing operations. Your primary responsibilities will include managing vial thaw, cell counting, and seed expansion activities. Additionally, you will oversee media preparation, wave bioreactor, and SS bioreactor operations. It will be your duty to ensure proper documentation practices are followed, including maintaining Batch Manufacturing Records and Special Process Requirements. Furthermore, you will be accountable for the documentation of Quality Management Systems, such as deviations, change controls, and risk assessment documents. Your role will also involve managing facility maintenance in compliance with cGMP guidelines to ensure operational efficiency and adherence to quality standards. Overall, as a Senior Executive in the Upstream Manufacturing Department, you will play a critical role in ensuring the smooth functioning of manufacturing processes and maintaining high-quality standards in all operations.,

Qualification :- M.Sc Microbiology / B.Tech / B.E Biotechnology Experience :- 1 to 4 year Experience in Upstream and Down Stream Processing

Role & responsibilities Working on unit operations related to upstream processing during DS Manufacturing. GMP Documentation related to DS manufacturing. Preparation of documents like SOPs, MMDs and QMS related documents like change control, deviation, CAPA, Risk assessment. Preparation and maintenance of virus stocks. Coordination with cross-functional team. Involvement during regulatory audit preparation. Preferred candidate profile Must have experience in Biopharma

Role & responsibilities Responsible for cell revival, subculture, cell counting of MRC-5 cells. Preparation of MCB/WCB. Experience in Preparation of media and in process buffers in media mixing vessels. Experience in handling Roller bottles, Cell stacks, TCFs. Experience in working in GMP conditions / production department of viral vaccines. Preparation of SOP, BMR’s, Protocols related to cell culture / virus culture. Experience in virus infection, virus harvesting procedures. Experience in working with Chicken embryo fibroblast cells, pooling of embryos, seeding of RB’s . Preparation of Media, in process solutions using preparation vessels. Preferred candidate profile Candidate should have experience in Cell Culture vaccine 6 days work from office based at Ahmedabad

M.Sc. (specialization in any Life sciences) with 4- 10 years relevant experience Experience in aseptic processing in GMP Classification and cell culture is (at least in mammalian cell culture) required; experience in the automated T-cell culturing process, washing, harvesting, and Cryopreservation is preferred. Hands-on experience or understanding in developing, manufacturing CAR-T cell therapy products is preferred. Experienced/Participated in aseptic process simulation, proficient in aseptic techniques, especially in aseptic filling of drug products, Biosafety cabinet operations, clean room behaviors, sterile welding, sealing, sterile transfer, etc. Good exposure or understanding of QMS aspects (Change control, Risk Assessment, Deviation, Preparation of Investigation report, and CAPA). In-depth understanding of Cell & Gene Therapy Manufacturing/development and associated regulatory guidelines. Roles & Responsibilities: Responsible for optimization of CAR cells manufacturing processes using normal human or patient-derived primary blood components, following ethical practices and QMS as per GMP guidelines Actively manufacture CAR-T cell therapy products by diligently prioritizing the lab functions to meet critical deadlines Establish and carefully execute transduction by viral vector and non-viral vector-based approaches, activation, and expansion of immune cells (T cells, NK cells, etc) isolated from clinical specimens without compromising sterility and quality parameters as per the guidelines and defined criteria by maintaining highest standards Able to communicate effectively in a highly matrixed team environment to advance the company's cell therapy pipeline Participate and assist in technical transfer and core R&D activities To review and prepare document SOPs, protocols, and reports pertaining to the program requirements Work closely with cross-functional teams to design and implement cell therapy processes and workflow for cell therapy platforms Provide critical technical/scientific recommendations for the manufacturing process improvements Work with vendors to evaluate raw materials and consumables for compatibility with the Manufacturing process Coordinate very closely with quality control, quality assurance, supply chain teams, etc, and strictly adhere to the project timelines by preserving integrity, accuracy, safety, and quality Prepare and participate in compliance monitoring inspections / regulatory agency interactions Able to troubleshoot experiments, record, analyze, interpret, and present the data in scientific meetings Understanding of systems and processes regarding sterile practices, work ethics, safety, health, and environment Ability to work off-shift and irregular hours as required Competencies: CAR-T manufacture under GMP settings Proficient in Aseptic Operations Culture of T cells/NK cells and handling of viral vectors Statistical analysis, Presentation & Communication Skills Documentation and Report Writing Interpersonal Skills Team Player / Team Management

The intern will assist the training team in curating and delivering internal training courses/programs targeting new hire orientation and basic technical trainings for customers as well as internal sales force. Main Responsibilities & Tasks: Contribute constructively to and assist in the preparation, running and evaluation of the customer trainings and internal training courses Assist regional training manager, internal specialists and external partners to design and deliver training courses for internal staff and customers Research modern learning methods and trends Qualifications & Skills: Student doing master's program in life science related field 0 to 6 months internship experience or training/teaching experience in life science related field a plus Understanding of Biopharmaceutical processes and applications a plus Mindset to explore interesting methodologies to impart training Affinity to digital communication and collaboration tools Passion for science and teaching; open and fast learner on new technology; attention to details; excellent organizational and communication skills Proficiency in English language Experience in MS office applications such as Microsoft Excel, Word and PowerPoint

Role & responsibilities Collaborate with stakeholders to deliver and develop Digital Centers of Excellence to unlock new opportunities and drive efficiencies for clients. Manage end-to-end delivery of projects for upstream clients in the areas of strategic decision-making, project management, digital transformation, cost optimization and so on. Accelerate clients transformation journey towards a more connected, optimized, lean and agile organization. Assist senior management and leadership for drafting proposals, writing client pitches, and developing solution architecture. Identify and quantify cutting-edge industry specific digital disruption opportunities for upstream clients through convergence of analytics & digital capability around upstream operations, well integrity and worker safety Preferred candidate profile MBA from Tier-I business school An Upstream engineer with experience in well operations (offshore, unconventional wells) with knowledge and experience in supporting operations 9-13 years of work experience Strong experience in client engagement during the entire lifecycle of the project across inception, sales and delivery Must have demonstrated leadership skills in developing a practice, preferably in the management consulting space Proven experience in solving complex business problems and delivering client satisfaction Must have led a team of 5+ resources in past engagements Has experience with business development across but not limited to client pitches, Request for Proposal response and proposal development and solution architecture. Relevant industry experience with strong blend of consulting and functional skills Perks and benefits

Role & Responsibilities : 1. Candidate will be working as Shift-Incharge 2. Will be responsible for managing upstream/downstream processes 3. Should be well versed with operation of fermeners 4. Mammalian/Microbial Cell Culture exp. 5. In-Depth knowledge of QMS, Documentation and GMP Preferred candidate profile : Must have 3 to 7 years of exp in upstream/downstream of Biosimilar Manufacturing

Qualification :- M.Sc Microbiology / B.E / B.Tech Biotechnology Experience :- 0 tO 5 years Location :- Manjusar ( Vadodara) Hand on experience in Fermentation , Upstream & Downstream experience

Role & responsibilities To perform manufacturing operations smoothly for the supply of bulk and small media as per market requirement Preparation and maintenance of Master & working cell banks, Virus banks for different antigens Knowledge of planning and executing the scale-up of fermentation processes Handling of different capacities of fermenters from small scale to pilot scale. Involved in microbial upstream and primary downstream processes. Responsible for smooth operation of all downstream equipment and monitoring of downstream process including filtration, purification and final filtration. Coordinating with internal and external departments like QC, QA, and engineering. Prepare the daily activity report and do the online documentation Preferred candidate profile • 4 to 10 years of experience in biologicals bio process area. Should have experience in handling various bioreactors adherent and suspension cell cultures, cell passaging. Exposure to regulatory audits.

Position Title : Senior Scientific Officer/Scientific Officer Grade : E - 7 Reporting To : Section Manager Natureof Position : Permanent EducationalQualification : M.Sc. / M.Tech (Biotechnology/Microbiology) Experience : 4 to 7years Locationofwork : Lalru Roles and Responsibility: 1. Knowledge about the updated cGMP guidelines 2. Knowledge about Cleaning, Operation, documentation and maintenance of chromatography systems (AKTA series) and water bath. 3. Responsible for online documentation as per cGMP along with routine log book management of production activity and equipment. 4. Knowledge of qualification (IQ/OQ/PQ) of chromatography systems (AKTA series), TFF systems, and refrigerators, cold rooms, HVAC/UDAF and tanks. 5. To ensure the entire downstream processing activity to be carried out as per compliance and process requirement 6. Knowledge for preparation and implementation of SOP/BMR/Protocols 7. Knowledge of adsorption, desorption, depth filtration, coarse and micro filtrations, centrifugation, ultrafiltration systems, Ion exchange, size exclusion and affinity chromatography. 8. Responsible for the execution of the purification modification with project team as and when required. 9. Knowledge of column packing 10. To ensure the effective cleaning and sanitation of the Core area, and systems as per schedule. 11. To ensure GMP compliance as per the applicable National and International rules and guidelines Such as Schedule M and World Health Organization (WHO). 12. Well versed with UNICORN software and integrity tester 13. Well versed with handling of QMS elements 14. Media fill, sterile filtrations, online particle counter and chartless temperature recorder 15. Hand on in MS word and excel 16. Calibration and verification of weighing balances, pH meters and spectrophotometer. 17. Knowledge of vNPC monitoring Competencies Required: 1. Thorough knowledge and understanding of column chromatography, column packing and TFF systems . 2. Understand Aseptic Behavior aseptic handling, aseptic working & aseptic cleaning. 3. Must understand Sterile Operations, Scientific practices & process criticalities of Vaccine manufacturing. 4. Analytical approach – Good in trend analysis, data evaluation & process calculations. 5. Adequate, Timely & Quality deliverance/ Output within stipulated timeframe. 6. Effective Communicator 7. Understanding of different room grades and area monitoring. 8. Motivate Team and Enable High Performance 9. Effectively Manage Absenteeism / Vacancy 10. Effective Performance Reviews of the Team and their Training responsibilities Preferred candidate profile

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

Open Positions: Officer / Executive / Sr Executive Quality Assurance & Quality Control : Analytical Skill on HPLC, Electrophoresis, Microbiology, Document Review, IPQA, Quality Systems, GMP Compliance, QA-QMS Biosimilars Manufacturing: Downstream (Operation of Chromatography systems) & Upstream (Handling of Single use and Stainless-steel bioreactors) Experience: 2 to 10 years of relevant experience in Biopharmaceutical Qualification: B Sc / B. Pharm/B Tech / M Sc in Microbiology / Biotechnology / Chemistry/M. Pharm Date : 01st June 2025, Sunday Time : 08:30 AM to 06:00 PM (Registration will be closed by 12:00 PM) Venue : Hotel Pride , 5, University Rd, Narveer Tanaji Wadi, Shivajinagar, Pune, Maharashtra 411005, India Note: All positions are based out at Pune, Gotawade.

Role & responsibilities Department: R&D USP Designation: Sr. Research scientist II / Principal scientist-I Clone, Media and feed selection for new projects. Process development from small scale shake to bioreactor scale (1L, 5L, 20L) Scaleup, Product/Process studies to support commercial dossier submissions. Risk assessments early stage Hold time study for media, feed harvest Alternative vendor for critical raw materials and external Scientific and technically sound documentations Process improvement with new technology - yield and quality improvement Cell bank preparation Maintenances of RCB, MSCB, vials with proper documentation Preferred candidate profile

Role & responsibilities Understanding business of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Understand the analytical requirements of Biologics, Biosimilars, Vaccines, fusion proteins, peptides Develop and implement strategic sales plans to achieve revenue targets within the biopharmaceutical sector. Identify and pursue new business opportunities with biopharma clients Build and maintain strong relationships with existing clients, understanding their needs and ensuring exceptional customer satisfaction. Collaborate with cross-functional teams including technical experts, marketing, and operations to tailor solutions that meet client requirements. Keep abreast of industry trends, market dynamics, and competitor activities to identify potential opportunities and threats. Prepare and deliver presentations, proposals, and contract negotiations to secure new business partnerships. Provide regular updates and reports on sales performance, market trends, and client feedback to senior management. Ability to work independently and collaboratively in a fast-paced, dynamic environment. Demonstrated ability to think strategically and execute tactical sales plans to drive revenue growth. Preferred candidate profile communication, negotiation, and presentation skills Strong understanding of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Willingness to travel as required to meet with clients and attend industry events.

Roles and Responsibilities 1. Candidate should have good knowledge of maintaining all equipment / machines in consultation with maintenance department. 2. Candidate should have good knowledge maintaining flow of material as per man & material movements. 3. Maintaining availabilities of spares / change parts required for equipment / machines located in the department in consultation with Maintenance department. 4. Candidate should be responsible for operation, cleaning of STR and wave bioreactor & operation and cleaning of chromatography system, chromatography column, TFF system and related equipment. 5. Candidate should be responsible for seed generation / expansion and handling of culture. 6. Candidate should be responsible for calibration of instruments, maintenance of status label of instruments, equipment and area. 7. Monitoring of area cleaning and maintenance as per cGMP requirements. Preferred candidate profile 1.Candidate should be qualified M.sc Biotechnology / M.sc Microbiology should have 2 to 4 years of experience handling Upstream Process. 2. Responsible to fulfil the operational requirements of area as per cGMP requirements. Issue & receipt of raw materials from stores required for batch operation as per BMR process. 3.Responsible for proper gowning & change as per relevant SOP and execution of batches as per BMR. 4. Candidate will be responsible for filling of logs and BMR & other cGMP documents as per requirement and reviewing SOPs of all activities of the line. 5.Candidate will be responsible to perform pre-operational checks and line clearance from Q.A. prior to each operation. 6. Candidate will be responsible for movement of materials for destruction of rejects generated during operation reporting any abnormal observation to superior during operation.

Key Responsibilities: - An executive with extensive expertise in Biologics Manufacturing: Product Technical Life Cycle Management. - Lead MSAT cell culture upstream projects and technical investigator. - Planning and designing using DOE approach for process development and characterization of upstream operations. - Working as team with other cross functional teams and contributing the domain expertise for advancing the pipeline molecules as required. - Identify opportunities for improving the product quality and quantity as per current and future market demand. - Hold time study of all process intermediate, reagent, media & Feed. - Perform all functions associated with process transfer and scale up to manufacturing e.g. develop process understanding, perform gap analysis / FMEA / RCA, generate process models, author / review process descriptions and batch Records, support equipment commissioning, process training, and validation activities. - Perform all functions associated with process monitoring, trending of in process and lot release parameter and quality data by using various software tools e.g. manufacturing data summary and analysis, data presentation; author campaign summary reports, assess deviations and process changes. - Continuous monitoring of manufacturing batches of assigned projects. - Review of protocol, study report, SOP and review of lab documents. - Play a member role in resolving technical issues for all functions to improve compliance throughout the site. Serve as investigation team member for process-impacting deviations and investigations. Provide technical guidance on change controls and how they might impact the processes and product specifications. - Statistical data analysis & Develop the Statistical model for the batch monitoring.

Role & responsibilities Lead or support process design, continuous improvement, and optimization of upstream unit operations (e.g., seed train, production bioreactors, harvest systems) Develop, review, and approve process documentation including P&IDs, process descriptions, interface to Automation Work collaboratively with cross-functional teams in MSAT, Quality, Engineering and Operations to ensure seamless tech transfer and process implementation Troubleshoot process-related issues during manufacturing campaigns and provide real-time support Participate in capital projects involving design or retrofit of biopharmaceutical facilities, including equipment selection, specification, and commissioning/qualification Evaluate and implement process improvements for robustness, yield, and productivity enhancements Maintain awareness of new technologies and trends in upstream and downstream processing Preferred candidate profile We are seeking a highly motivated and skilled Process Engineer with a strong background in biopharmaceutical manufacturing or process design , preferably with expertise in upstream operations . This role focuses on upstream unit operations including bioreactor design and operation , centrifugation with an added advantage for candidates who bring cross-functional exposure to downstream purification processes as well.

Role & responsibilities Upstream and Downstream Process Handling: Manage and monitor both upstream (fermentation) and downstream (purification, recovery, etc.) processes to ensure the smooth production of biotechnological products. Operate and maintain equipment involved in these processes. Fermentation Expertise: Operate fermentation systems, monitor fermentation parameters, and ensure optimal conditions for microbial growth and product yield. Handle fermentation media, inoculation, and harvest processes. Dry Heat Sterilization: Perform dry heat sterilization for equipment, media, and related items as per SOPs to ensure sterile conditions are maintained in the production environment. Critical Shift Process Management: Oversee critical shift operations during fermentation and other biotechnological processes. Ensure processes are running according to predefined protocols and handle any process deviations or issues during shifts. Compliance with cGMP & Documentation: Ensure all activities are conducted in compliance with current Good Manufacturing Practices (cGMP). Maintain and update necessary documentation, including batch records, process logs, and compliance reports. Troubleshooting & Process Optimization: Troubleshoot any issues or deviations in the production processes and provide solutions. Assist in process improvements and optimization activities to enhance production efficiency and yield. Safety & SOP Adherence: Ensure all safety protocols and standard operating procedures (SOPs) are strictly followed during biotech production activities. Participate in training sessions to stay updated on safety, regulatory, and technical advancements. Cross-functional Collaboration: Collaborate with other departments such as Quality Control (QC), Quality Assurance (QA), and Maintenance to ensure the production process runs smoothly and meets the required standards. Preferred candidate profile Graduate in Science (e.g., Biotechnology, Microbiology, Biochemistry, or related field). Minimum 3 years of proven experience in biotech production, specifically in fermentation and downstream/upstream processing within the pharmaceutical/API industry. Extensive experience in fermentation processes. Hands-on experience with downstream and upstream processing techniques. Thorough understanding of cGMP regulations and documentation requirements. Proficiency in dry heat sterilization and handling critical shift processes. Knowledge of relevant equipment and instrumentation. Strong analytical and problem-solving skills. Excellent communication and interpersonal skills. Ability to work effectively in a team environment. Strong attention to detail and accuracy. Ability to work under pressure and meet deadlines. Adaptability to changing priorities and tasks.

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 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 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