15 Upstream Processing Jobs

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.