15 Aseptic Processing Jobs

Dr. Reddys is looking for Manufacturing Scientists or senior scientists specialized in cell therapy (CAR-T) programs to join their Manufacturing facility team. As a Manufacturing Scientist, you will collaborate with Research and Product Development teams to support GMP Manufacturing operations, Technology transfer, quality assessments, and process validation of the CAR-T process for various Cell therapy programs. Your responsibilities will include designing and executing experiments to develop robust manufacturing processes for cell therapy products, leading and training a team of cell process scientists/engineers, managing T-cell culture and differentiation, documenting experimental procedures and results, supporting the development of SOPs and batch records, and reviewing production batch records for deviations and investigations. You will also be responsible for communicating progress, identifying critical issues affecting supply and timelines, collaborating within departmental teams, contributing to deliverables, serving as a technical subject matter expert for technology transfers, and aligning with leadership to develop a strategic roadmap on continuous medium optimization. To qualify for this role, you should have a PhD/MSc/BSc in biotechnology, biology, immunology, Cell Biology, or a related life-science discipline, along with 5-12 years of industry experience in Cell and gene therapy, biologics manufacturing, or product development functions. Experience in aseptic processing, cell culture, automated equipment, T-cell culture processes, GMP requirements, and DOE is required. Strong organizational, communication, and decision-making skills are essential to succeed in this role. If you are a dynamic individual who can work in a fast-paced environment, collaborate effectively with teams, and drive successful outcomes in manufacturing processes, this position offers an exciting opportunity to contribute to cutting-edge cell therapy programs at Dr. Reddys.,

Role & responsibilities Manufacturing of cell line/cell culture based AG for FG Cell culture operations, including inoculation and observatory monolayer work Compilation of all commercial batch data and BMR filling RM/PM issuance, sterilization, and monitoring of all supportive data Maintaining procell-related modules, areas, and utility fixed assets Receiving NPD from R&D and scaling up for commercialization Areas, equipment validation, and maintenance Cell bank passage history maintenance and reconciliation Preferred candidate profile Throughout knowledge of cell line/primary culture Propagation of cell line & maintenance Aseptic handling Sound knowledge of QMS Sound knowledge of cGMP, GDP

We are looking for an innovative and experienced quality analyst to join our team. The quality analyst is responsible for developing and supporting the planning, design, and execution of test plans, test scripts, and process plans for projects. The successful candidate will work closely with various departments to perform and validate test cases based on quality requirements, and recommend changes to predetermined quality guidelines. You will be responsible for ensuring that the end product meets the minimum quality standards, is fully functional and user-friendly. To be successful as a quality analyst, you should demonstrate strong attention to detail and have analytical and problem-solving abilities. The ideal candidate must be able to interpret and implement quality assurance standards and provide accurate and comprehensive feedback to colleagues. Quality Analyst Responsibilities: Develop and execute test plans to ensure that all objectives are met. Implement and monitor test scripts to assess functionality, reliability, performance, and quality of the service or product. Identify and remedy defects within the production process. Recommend, implement, and monitor preventative and corrective actions to ensure that quality assurance standards are achieved. Compile and analyze statistical data. Ensure that user expectations are met during the testing process. Draft quality assurance policies and procedures. Investigate customer complaints and product issues. Ensure ongoing compliance with quality and industry regulatory requirements. Quality Analyst Requirements: A bachelor's degree in computer science, information systems or a related field. Experience in quality inspection, auditing, and testing. Excellent communication skills, both written and verbal. Strong computer skills and knowledge of QA databases and applications. Strong analytical and problem-solving skills. Meticulous attention to detail.

We are seeking a motivated and detail-oriented Injectable Plant Compliance Manager to join our team. The ideal candidate will be responsible for ensuring compliance with all regulatory requirements and industry standards specific to the production of injectable pharmaceutical products. This role will serve as a key leader in maintaining quality assurance, overseeing audits, and implementing compliance systems to ensure the safety and efficacy of our products.

Manager - Processing (Production) Role: We are seeking a dynamic and seasoned individual responsible for overseeing day-to-day processing operations in sterile manufacturing, ensuring alignment with production schedules and regulatory standards. The role focuses on identifying process inefficiencies, leading improvement and automation projects, and collaborating with cross-functional teams to drive productivity, reduce waste, and enhance product quality. This position demands strong technical knowledge of sterile processing equipment and a proactive approach to maintaining seamless production workflows and continuous operational improvements. Location: Umarsadi (Vapi, Gujarat) Main Tasks: Manage and oversee work orders for our product lines, ensuring efficient execution of production plans to maximize machine performance. Plan and implement batch production on a product-specific basis, optimizing throughput and minimizing downtime. Collaborate with cross-functional departments to ensure uninterrupted operations and timely execution of preventive maintenance schedules. Lead initiatives to reduce market complaints, aiming to maintain a production ratio of over 20 million units per justified complaint. Review BMR for new products to be processed on syringe lines. Review and approve BMRs for new products prior to processing and verify completed BMRs for submission to Quality Assurance. Develop, review, and implement SOPs for syringe processing operations, ensuring thorough training and compliance among line operators. Monitor and enhance line yield while working to minimize rejection rates through process improvements and quality control measures. Ensure timely preparation of customer samples as per specifications, with accurate documentation in BMRs and logbooks. Oversee SAP activities related to batch processing, including data entry, reconciliation, and return of unused materials to inventory.. Ensure optimal shift-wise performance of SPRC machines, maintaining complete and accurate documentation in SAP, BMRs, and logbooks. Prioritize and coordinate the ETO process of completed batches, ensuring all related entries are updated in both BMRs and SAP. Maintain audit readiness by ensuring no critical observations in the production area through strict compliance and monitoring. Ensure NVPC records are correctly attached to the respective BMRs and submitted to QA within the designated timeline. Lead training programs for staff and operators on cleanroom protocols and enforce adherence to cGMP standards. Ensure full compliance with the most recent EHS guidelines across all production activities. Drive continuous improvement of the EHS management system through effective implementation, monitoring, and periodic review. Requirement: M.Pharm /B.Pharm /B.Sc /M.sc / BE (Chemical, Electrical, Instrumentation, Mechanical) from an accredited institution. Experience: Proven record of 12+ years in Junior Management in any Pharmaceutical industry with relevant experience in the area of Process Engineering. Competencies: Strong organizational skills and attention to detail. In-depth knowledge of sterile processing equipment: Washing Systems, Depyrogenation Tunnels, Sterilizers, Siliconization Systems. Sound understanding of cGMP, GEP, FDA/ regulatory requirements, and cleanroom operations. Strong command over lean manufacturing, root cause analysis, CAPA, and risk assessment tools. Strong leadership with proven ability to motivate and guide cross-functional teams. Skills: Proficiency in local languages and English, both written and spoken, to facilitate effective communication with employees and stakeholders. Knowledge of SAP, MS Excel, PowerPoint, etc. Strong learning agility and continuous improvement mindset. Contact: careers.hr@schott-poonawalla.com

Role & responsibilities Assisted senior microbiologists in performing various microbiological tests, including sterility testing, bioburden testing, and environmental monitoring. Maintained accurate records and ensured compliance with GMP and SOP guidelines. Prepared and sterilized microbiological media and reagents. Performed routine equipment maintenance and calibration. Contributed to the development and improvement of laboratory procedures. Preferred candidate profile

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

Urgent requirement For Production Injectables In Formulation Division - Kothur & RK Puram Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- Operators :- Filling | Aseptic | PFS | VIAL | OPHTHALMIC Filling machine | Bottle sealing or Capping | Product & Disinfectant filtration activities | log books & BMR recording | Filling machine PHT,CIP & SIP operations Division :- Formulation Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Walk In Drive For Production Injectables In Formulation Division @ Corporate Office Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- Operators:- Filling | Aseptic | PFS | VIAL | OPHTHALMIC Filling machine | Bottle sealing or Capping | Product & Disinfectant filtration activities | log books & BMR recording | Filling machine PHT,CIP & SIP operations Division :- Formulation Interview Date:- 15-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSN Formulation Unit II, Kothur & MSN Formulations Unit- V, RK Puram Venue Location:- MSN Corporate, H. No. 2-91/10 & 11 /MSN, Whitefield's, Kondapur, 500084 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Walk In Drive For Production Injectables In Formulation Division @ Bollaram Department:- Production Injectables Qualification :-ITI | BA | Diploma | B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Skills :- LYO operator | Packing | Packing (Labelling) | Vial Filling & sealing | Compounding | QMS & Documentations | Autoclave | Aseptic processing area | Vial washing & Tunnel | Filling Division :- Formulation Interview Date:- 08-06-2025 Interview Time :- 9.00AM TO 2.00PM Work Location:- MSNF-II , Kothur | MSNF-V, Rk Puram Venue Location:- Plot No- 42, Anrich Industrial Estate, Bollaram Village, Hyderabad, Telangana 502325 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Sterile Operations Trainer Grade: G8 Designation: Deputy General Manager Location: Halol 1 Job Description: Education: B. Pharm / M. Pharm Overall responsibility of Aseptic Training Academy (ATA), Baska To plan, develop, and execute training at Aseptic Training Academy (ATA) - Sterile Operations for Sun Global Operations (SGO) Training. Creation of simplified training modules for technicians, scheduling and execution of training Creation of training evaluation and/or feedback systems Course creation according to levels (Level 1 - Technicians, Level 2 - Supervisors and above, Level 3 - Managers and above) pertaining to sterile operations Planning, scheduling & execution of technical training program relevant to sterile operations for new recruits/for existing employee by self/internal or external facility Identification of Certified trainer at various locations (sterile operations) based on additional training need of respective location Coordination with location head and Subject Matter Expert (SME) for conducting the additional training program according to training calendar on monthly basis pertaining to sterile operations To prepare and submit SGO training score card for sterile operations on monthly basis after plant review to Corporate Quality Policy and Training department (CQPT) To maintain the training records of training Periodical review of technical courses along with business units for site specific course and the head of course for suitable course content / design and pedagogy up gradation To coordinate in technical course scheduling and publishing of calendars and facilitate visiting faculty/guest faculty in course delivery Any other work assigned by superiors from time to time

Walk In Drive For Production Injectables In Formulation Division @ Jadcherla Department:- Production Injectables Qualification :-ITI| BA | Diploma |B Com | BSC | B Pharmacy Experience :- 2 To 8 Years Division :- Formulation Interview Date:- 01-06-2025 Interview Time :- 9.00AM TO 2.00PM Venue Location:- ELITE HOTELS & RESORTSNH44,Bangalore Hyderabad Hwy Jadcherla, Telangana 509301 Contact No:- 040-304338701 | 8954 Note:- Candidate should bring Update Resume , Increment Letter, Pay slips, Bank Statement, Certificates, Aadhar Card & Pan Card We are looking for candidate those who have experience in Lyo, Compounding, Autoclave,Vial Filling, Vial Washing, Sealing,Aseptic Processing Area, Tunnels, Labelling, About Company:- MSN Group is the fastest growing research-based pharmaceutical company based out of India. Founded in 2003 with a mission to make health care affordable, this Hyderabad-based venture has Fifteen API and Six finished dosage facilities established across India & USA. The group has an integrated R&D center for both API and formulation under one roof, dedicated to research and development of pharmaceuticals to make them more accessible. With core focus on speed and consistency in delivery, MSN has achieved the following: More than 900+ national and international patents Product portfolio featuring over 450 + APIs 300+ Formulations, covering over 35 major therapies Won the trust of more than 40 Million patients across 80+ countries globally Innovation and speed form the crux of our business strategy. Backed by a dedicated and experienced team of over 14,000 the organizational environment at MSN integrates multiple disciplines and functions by effective implementation of goals and objectives through technology, coupled with Integrity, Imagination and Innovation.

Position : Assistant Manager - Production (PET Line) Qualifications: B.Tech in Dairy/Food Technology / BE Mechanical Experience: Minimum 6 - 10 years experience in multiple products manufacturing –like UHT milk, flavored milk Juice, juice with milk blend in PET in reputed /large organization. Must have exposure to lead a sizable team Core Competencies: In-depth knowledge of Dairy products manufacturing plants, process technology and product development. Knowledge of food safety, regulatory requirements for food safety and hygienic engineering (OSH&R). Analytical skills in problem solving. Communication and networking. General understanding of financial analysis and relevant business drivers. The marginal contribution of the various products. An understanding of the competitor's products, how the product is distributed and the consumer's preferences. Support Tools MS Office SAP Key Responsibilities: Management Responsibilities” Define, propose and monitor the Production team plans and objectives in accordance with Key Principles and the Plant Management Activity. Lead and coordinate production team and maintain competencies, motivation and performance to achieve the team’s mission and objectives. Propose and control the cost relating to the production as well as FG. Propose and implement work processes, procedures and technical resources in accordance Key Principles and the Electricity & Automation Coordinate personnel (e.g. technicians, instrument fitters, contractors etc.) to ensure Electrical objectives are satisfied. Functional Responsibilities” Production management Coordinate personnel (e.g. other shift officers, technicians, contractors etc.) to ensure the production objectives are satisfied. Propose and control the cost of the production in accordance with the Guidelines for Capital Investment. Propose and monitor the production in accordance with the key performance indicators. Ensure work place safety and effective communication of Safety, Health and Environment to all team members. Understanding of certain process excellence tools like Lean six sigma, TPM, etc. Responsible for planning of spares as per schedules for timely delivery. Responsible for preserving the used spares and deposit in stores. To plan for minimum number of personnel to carryout production activities without causing any hindrance to the production. To plan and use minimum number of casual labour wages. Responsible to ensure that the full cooperation is given to conduct internal and statutory audit. To go through the audit queries, analyze and initiate compliance action immediately. To ensure that the issues raised in Audit are not repeated again. Operation and Maintenance of Plant: Follow the requirements of Good Manufacturing Practice, HACCP, Quality System, Hygienic engineering, Ergonomic engineering etc. Liaise with Packaging, New Product Development, Production, Quality Management and Marketing to resolve technical issues Specify any maintenance requirements, procedures and checks which relate to the process lines. Manage/control a database relating to process engineering. To plan and prepare preventive maintenance schedules for process and packing station at different intervals like daily, monthly, etc. To review the records of the findings of preventive maintenance schedules, after implementation during the visits to all section Initiate and drive Continuous Improvement. This must not be limited to machinery and assets but must also include systems, processes, methods, organization, staffing and employee skill levels. Drive the correction of process related product quality and/or operational performance deviations. Hands on experience in Man Management, statutory and legal compliance. Ensure that both operators and trades have sufficient process and plant function knowledge to optimize the operation of the plant and the manufacture of quality product. Continuously challenge the way things are done and be always looking for opportunities Functional Responsibilities Continued.. Ensure that the operators and mechanics, who are the ones closest to the product, receive direct on the line coaching in machinery and line operation skills such that they understand. Provide leadership for effective utilization of resources like- manpower, machine raw material and time efficiently to produce quality product for achieving organizational goals. To provide leadership to men working in the department and be accountable for their performances. Ensuring manufacturing of products as per customer expectations within budgeted norms. To participate in the management review meetings and add value towards continuous improvement of the system. To participate in the inter departmental communication like HR, QC, Store, Safety, Utility for smooth running of the plant. To work out new cost saving measures & energy management in technical operations, manufacturing & maintenance operations. RM/PM change or process change. Conducting end to end trials at plants for any RM/PM change or process change. Keep track on salvage/rework generation & utilization of the same within prescribed limit as per food safety. Good command on PLC operation Monitoring and control on production losses and optimization of production cost by line efficiency monitoring and inventory control. Proper inventory management & production planning as per sales demand. Troubleshooting at plant level as and when required. To provide production support in case of new line commissioning To assign work to direct reports, who in turn will allocate work to the officers, operators. To ensue overall hygiene and sanitation inside the concerned section. Responsible to maintain hygienic of all machinery / equipment / instruments. To ensure plant hygiene is of international standards and to follow the checklist given for the purpose. Responsible for timely disposal of all types of scrap in consultation with Purchase Manager / Manager – Stores. To ensure all process conditions are maintained within the specifications. To identify and assess training needs of the subordinates in the department. Accountable for safety of product, equipment and personnel working in the department Provide the all required accessories in the section. Share all required information with the higher ups & the sub-ordinates. Check the feasibility of the new process excellence ideas and cost efficiency program To deal with contingencies arising in the department in consultation with immediate superior. Key Performance Indicators Actual production cost as a percentage of the originally approved credit. Recovery of total solid in the prescribed range & improvement opportunities on the same Reconciliation of RM, PM time to time to keep it in the prescribed range. Keep the plant up to date & Audit ready always Continuous, efficient and reliable operation of the plant measured using selected KPIs Continuous improvement of operations. Operation meets regulatory requirements. P sist in the development of a competent and effective workforceP

Spearheading the Production Department Production Yield Planning and calculation Manpower Mangement Breakdown Analysis Cost vs Production Analysis Required Candidate profile Should have handled multiple lines, candidate from aseptic background will be prefered

Sterile Operations Trainer Grade: G9 Designation: Senior Manager Location: Halol 1 Job Description: Education: B. Pharm / M. Pharm Overall responsibility of Aseptic Training Academy (ATA), Baska To plan, develop, and execute training at Aseptic Training Academy (ATA) - Sterile Operations for Sun Global Operations (SGO) Training. Creation of simplified training modules for technicians, scheduling and execution of training Creation of training evaluation and/or feedback systems Course creation according to levels (Level 1 - Technicians, Level 2 - Supervisors and above, Level 3 - Managers and above) pertaining to sterile operations Planning, scheduling & execution of technical training program relevant to sterile operations for new recruits/for existing employee by self/internal or external facility Identification of Certified trainer at various locations (sterile operations) based on additional training need of respective location Coordination with location head and Subject Matter Expert (SME) for conducting the additional training program according to training calendar on monthly basis pertaining to sterile operations To prepare and submit SGO training score card for sterile operations on monthly basis after plant review to Corporate Quality Policy and Training department (CQPT) To maintain the training records of training Periodical review of technical courses along with business units for site specific course and the head of course for suitable course content / design and pedagogy up gradation To coordinate in technical course scheduling and publishing of calendars and facilitate visiting faculty/guest faculty in course delivery Any other work assigned by superiors from time to time