94 Scale Up Jobs - Page 2

Manage entire technology transfer from R&D to manufacturing. Lead pilot plant trials/scale-up protocols Work closely with Production/QA/EHS teams Conduct fit-gap assessments Monitor pilot batches/readiness for commercial launch Required Candidate profile 4+ yrs exp in tech transfer/pilot scale-up in Pharma/specialty chemicals Familiar with distillation/extraction/solvent recovery/filtration/drying system Expert in GMP/EHS practices

Role & responsibilities To lead the OSD department team and ensure manufacturing process development and Optimization as per the regulatory requirements & technology transfer of the projects in co-ordination with Production and planning department for regulatory & ROW products. Accountabilities and mandatory requirements: Ensure composition and manufacturing process development of new as well as established products and ability to improvise if needed. Ensure manufacturing process/new process within Budget for maximizing efficiencies of Formulation Department Lab. Guide group for day-to-day activities and informing Formulation Development Department (FRD) colleagues for the schedule and timelines for the product development as well as technology transfer of Exhibit, Validation or commercial batches. Ensure group co-ordinate with other functions including Purchase, Production for the status of availability of Raw Materials, Packaging Materials required for development batches/ exhibit batches/ Validation batches at site. Ensure development and stability data generation of the new as well as trouble shooting products as per the regulatory or ROW market requirements. Guide to the for encounter the trouble shooting of legacy products and to provide the Technology transfer documents to resolve or to overcome issues related to the legacy products to provide quality products to the customer. Guide group for the smooth technology transfer of new as well as existing products or trouble shoot products for better to meet the finished product specification. Ensure the Regulatory queries to be addressed in time and guide the group leaders to work on to provide comments on the received quires to be close within provided timeline. Work closely with cross functional team for planning /execution of the Technology transfer/Exhibit/Validation batches of the individual projects to meet the timelines assigned. Provide the technical oversight (guidance), Plan, co-ordinate and oversee the work activities related to technology transfer/Exhibit batches/Validation batches of projects not limited to EU authorization but also CMO/ROW projects. Ensure Compilation of Development batches/Exhibit batches/validation batches data included with critical observations and submission of the same to R&D Head. Co-ordinate with production department for planning of tech transfer /Exhibit/Validation batches and execution/monitoring of the batches of the products starting from dispensing of the materials till packaging of the product to ensure smooth technology transfer of the products complying to the regulatory requirements. Preferred candidate profile- - 8-12 years of experience in Regulated market- OSD formulation & Development and technology transfer. - Good communication, open exchange of information and project teamwork will be required in order to meet the job performance. - Will be expected to accomplish his work assignments by interacting closely with scientific staff/Production staff and by developing the co-operative working relationships with other personnel within the company. - Must be able to work/co-ordinate with different functions within ALS and prioritize the workload to meet the predetermined timelines and need to work as a team with open communication, transparency and mutual trust. - Proper documentation pertaining to Formulation Development as per the Regulatory requirements and as per companys system.

Role Description - Execute and support process scale-up from laboratory to pilot and commercial scale. - Industrial experience between 2 to 6 years. - Plan and execute new technology transfer and crosslinking batches. - Conduct batch monitoring and troubleshooting during pilot and routine production runs. - Prepare process documents such as PPs, PRIDs, SOPs. - Participate in process optimization and yield improvement activities. - Collaborate with functional teams including production, QA/QC, and EHS. - Ensure compliance with safety and regulatory standards applicable to the chemical industry. Qualifications - Bachelors degree in Chemistry, Chemical Engineering, Biochemistry or related field - Strong understanding of chemical process engineering and unit operations - Experience with batch operations - Good analytical problem-solving skills - Effective communication coordination abilities - Knowledge of safety regulatory practices in chemical industry

Job Description: NDDS (Novel Drug Delivery System) Scientist - OSD will be responsible for designing, developing, and optimizing advanced drug delivery systems in oral solid dosage forms such as tablets, capsules, and controlled-release formulations. This role requires expertise in pharmaceutical formulation, process development, and a thorough understanding of regulatory requirements. Formulation Development: Design and develop NDDS formulations for oral solid dosage forms, including immediate release (IR), extended release (ER), and modified release (MR) products. Perform pre-formulation studies, including solubility, stability, and compatibility evaluations. Technology Integration: Implement innovative drug delivery technologies, such as microencapsulation, nano-particle systems, and multi-layer tablets. Optimize drug release profiles to enhance therapeutic efficacy and patient compliance. Process Development: Develop scalable and robust manufacturing processes for oral solid dosage forms. Perform critical parameter optimization for processes like granulation, blending, compression, and coating. Analytical and Stability Studies: Collaborate with the analytical team to develop and validate testing methods for NDDS products. Conduct stability studies in compliance with ICH guidelines. Regulatory Compliance and Documentation: Prepare technical reports, protocols, and batch manufacturing records. Ensure compliance with cGMP, ICH, and FDA guidelines during formulation and process development. Technology Transfer: Oversee the transfer of lab-scale formulations to pilot-scale and commercial manufacturing. Work closely with production, quality assurance, and regulatory teams to ensure seamless transfer. Innovation and Research: Stay updated with emerging trends in NDDS and oral solid dosage technologies. Contribute to patent applications and publications to support organizational innovation initiatives. Key Requirements: M. Pharm / M.S. in Pharmaceutics or related field. 4 to 7 years of relevant experience in formulation development of OSD for USFDA or other regulated markets. Strong knowledge of QbD, scale-up and technology transfer. Experience in developing formulations for bioequivalence studies and regulatory submissions. Familiarity with USFDA/EMEA regulatory guidelines and documentation. Excellent problem-solving, documentation, and communication skills. Preferred Skills: Hands-on experience with granulation, compression, coating, and capsule filling equipment. Ability to work cross-functionally in a fast-paced, deadline-driven environment.

Job Overview: The PDL Scientist - Injectable will be responsible for the development, optimization, and scale-up of sterile injectable formulations and manufacturing processes. The role demands expertise in injectable formulation science, process engineering, and compliance with regulatory and quality standards. Role & responsibilities Formulation Development: Design and optimize sterile injectable formulations, including solutions, emulsions, and suspensions. Perform compatibility and stability studies of active pharmaceutical ingredients (APIs) with excipients. Process Optimization: Develop robust, scalable manufacturing processes for injectable formulations. Define and optimize critical process parameters (CPP) and quality attributes (CQA). Sterility Assurance: Establish aseptic processes and ensure compliance with sterility requirements. Perform filtration studies, autoclave cycle development, and validation. Analytical Support: Collaborate with the analytical team for the development and validation of testing methods. Conduct particle size analysis, pH, and osmolarity evaluations, and other critical tests. Regulatory Compliance and Documentation: Prepare technical reports, batch records, and regulatory submissions in compliance with GMP, ICH, and FDA guidelines. Support regulatory inspections and audits with comprehensive process documentation. Technology Transfer: Facilitate the transfer of processes from lab-scale to manufacturing-scale environments. Work closely with cross-functional teams, including production, quality assurance, and regulatory affairs. Preferred candidate profile 3 - 5 years of experience in injectable formulation and process development. Hands-on experience with lyophilization, sterilization techniques, and aseptic manufacturing processes. Strong knowledge of GMP, ICH, and regulatory guidelines. Proficiency in using laboratory equipment such as autoclaves, lyophilizes, and HPLC systems. Excellent technical writing and documentation skills.

We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987

1. Detailed Process Understanding on Unit Operations (Distillation, Extraction, Filtration, Drying, Absorption, Stripping) 2. Data generation in Lab / Pilot for Improvement in Existing Plant as well as for Commercial Scale up Required Candidate profile 3. BEP Preparation – Process Flow Diagram, Material Balance, Energy Balance, Standard Operating Procedure, Effluent Treatment, Process Safety Data Generation

Applications are invited for the Post of Junior Research Fellow ( JRF ) for the ANRF-SERB funded Core Research Grant (CRG) Project in the School of Chemical Engineering (SCHEME), at Vellore Institute of Technology (VIT), Vellore (Sanction order dated 01 August 2024) Title of the Project : “ Design and Characterization of Novel Hydrodynamic Cavitation Reactor for Wastewater Treatment” Qualification : M. Tech / M.E in Chemical/Environmental Engineering, or a related engineering field with one or two years of experience in water and wastewater treatment is desirable. Describe if any : Candidates having knowledge in conducting lab/pilot scale experiments in wastewater treatment will be given preference. Stipend : Rs. 37,000/- per month + HRA (As per Institute norms). Sponsoring Agency : Science and Engineering Research Board Duration : 3 Years Principal Investigator : Dr. K.Sivagami, Assoicate Professor, School of Chemical Engineering, Vellore Institute of Technology (VIT) Vellore - 632 014, Tamil Nadu. Send your resume along with relevant documents pertaining to the details of qualifications, scientific accomplishments, experience (if any) and latest passport size photo etc. on or before (27 /05/2025) through online http://careers.vit.ac.in. No TA and DA will be paid for appearing in the interview. Shortlisted candidates will be called for an interview later which will be intimated by email. The selected candidate will be expected to join at the earliest.

Key Responsibilities - Develop, implement, and maintain applications using Langchain and Core Python. - Design and integrate APIs using FAST API and manage backend services. - Collaborate with front-end developers using JavaScript, Node.js, and React to build seamless applications. - Leverage Azure Functions and Azure Logic Apps to automate workflows. - Write and optimize queries in T-SQL. - Ensure code quality, security, and scalability. - Stay updated with emerging technologies and recommend tools that enhance development efficiency. Required Skills - Strong expertise in Python development with hands-on experience in Langchain. - Experience with JavaScript, Node.js, and React. - Familiarity with Azure Functions and Azure Logic Apps. - Experience with T-SQL and FAST API. Apply Insights Follow-up Save this job for future reference Did you find something suspiciousReport Here! Hide This Job Click here to hide this job for you. You can also choose to hide all the jobs from the recruiter.

Execute and manage technology transfer of OSD products from R&D to manufacturing. Coordinate and monitor scale-up and exhibit batches in line with regulatory requirements. Ensure USFDA and other regulatory compliance throughout product development and scale-up. Prepare and review tech transfer documents , protocols, and reports (BMRs, MFRs, PVPs, etc.). Support investigation and troubleshooting of manufacturing issues, and suggest process optimization. Collaborate with cross-functional teams: R&D, QA, RA, Manufacturing, and SCM. Participate in audits and provide technical support during regulatory inspections. Drive continuous improvement initiatives to enhance productivity, cost efficiency, and quality. Qualifications: B.Pharm / M.Pharm in Pharmaceutics or related discipline. 7-11 years of relevant experience in Tech Services Hands-on experience with OSD formulations, preferably for the US market . Proven experience in scale-up , exhibit batches , and tech transfer. Strong understanding of regulatory guidelines (USFDA) Excellent documentation, communication, and cross-functional collaboration skills.

Roles & Responsibilities You will be responsible for end to end Formulation development of Injectable including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effective Proof of Concept (POC) for developing generic equivalent of Reference Listed Drug (RLD)/generic Injections. You will be responsible to support in scale-up to pilot/plant scales for Injectable Products. You will be responsible to monitor the development for robust, effective and bioequivalent drug product in timely manner adhering to safety and quality standards. Also provide support in documentation for regulatory submissions. You will be responsible for technology transfer and execution of the batches. You will be responsible for performing pre-formulation studies for material characterization, drug-excipient compatibility and Reference Listed Drug (RLD) characterization (including reverse engineering, formulation designing and optimization, processes designing and scale up). You will be responsible for preparation of risk evaluation and risk mitigation documents, Scale-up batch documents, and filing documents for drug product at every stage of development. You will be responsible to review data generated and participate in discussions with experts to conclude on prototype(s). Participate in strategizing the sourcing of Active Pharmaceutical Ingredient (API), raw materials and ensure development studies are performed related to regulatory and internal system requirements. You will be responsible for designing and implementing stability studies for injectable formulations to ensure product quality and shelf life. You will be accountable for troubleshooting formulation and process-related issues during development and manufacturing stages. You will collaborate with cross-functional teams to ensure alignment of formulation development with regulatory requirements and commercial objectives. You will be responsible for staying current with emerging technologies and regulatory guidelines in injectable drug development and incorporating them into your work. You will mentor junior scientists and contribute to the continuous improvement of the formulation development process. Qualification Educational qualification: Masters in Pharmaceutical/M.Tech in Chemical Engineering Minimum work experience: 5 to 8 years of experience in pharmaceutical company in Injectable products. Skills & attributes: Technical Skills Have work experience on Formulation Development and expertise in inhalation/injectable dosage form. Experience in areas of product development for Generic Injectable Experience in Quality by Design (QbD). Experience in Process Optimization and scale up. Experience in Operational Excellence. Knowledge on Good Manufacturing Practice and Good Laboratory Practice. Experience in Technology Transfer. Behavioral Skills Excellent communication and interpersonal skills. Strong analytical and problem-solving abilities. Ability to work collaboratively with own team and cross-functional teams. Additional Information About the Department Integrated Product Development Organisation We integrate our deep science capabilities and cutting-edge technology to develop innovative, accessible and affordable therapies for patients worldwide. We are a science-driven, innovation-focused pharmaceutical company committed to accelerating access to healthcare solutions to patients around the world. We have End to end capabilities in API, Formulations, Clinical, Intellectual Property and Regulatory Affairs. We are serving 55+ markets including USA, Canada, Europe, China, LATAM, ASEAN and all Emerging Markets with innovative and generic products ranging from Active pharmaceutical ingredients (API), Oral formulations, Parenteral (Injectables, Opthalmics) & Other dosages Our product development efforts drive a portfolio of more than 1,000 products Enabled by our robust R&D team consisting of more 200 scientists and functional experts and more than 150 doctorates, we have filed 1,071 patents and also published over 1,000 papers for peer review over the years. Benefits Offered At Dr. Reddy’s we actively help to catalyse your career growth and professional development through personalised learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards. They include, among other things and other essential equipment, joining & relocation support, family support (Maternity & Paternity benefits), learning and development opportunities, medical coverage for yourself and your family, life coverage for yourself. Our Work Culture Ask any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations, but as a means to help patients lead healthier lives, and we’re always attuned to the new and the next to empower people to stay fit. And to do this, we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic. For more details, please visit our career website at https://careers.drreddys.com/#!/

Role & responsibilities TSD Position Open: Executive to Senior Manager Job Location: HLL-1, Hyderabad Qualification : B.Tech/ M.Tech Chemical Engineering Experience : 4 - 20 years with Relevant experience Heat load calculation, material balance and power cost calculation. • Delivering capacity enhancement with minimum investment. • Identification of bottleneck equipment and debottlenecking to improve productivity. • Performing batch troubleshooting. • Scale up of new products from lab scale to plant scale, Implement and conduct validation trials. • To prepare process flow diagrams (PFDs) and P&ID • Ensure that the safety and GMP is followed at every stage of API. • Responsible for solvent loss reduction. • Facility creation or modification for new product and scale up batches as per Requirement. • Responsible for Batch Cycle Time (BCT & BCF) reduction of new and existing products. • To calculate annual capacity of various products. • Plant overall utilization calculations. • Estimation of Utility consumption and pipe line sizing. • Collection, collate and provide data to management for evaluation of existing process, operation and quality trends to check for consistency and scope for improvement. • Determining Equipment Equivalency for mapping. • To identify and implement scopes to meet demand. • To identify scope for continuous operations for large scale products Preferred candidate profile

Key Responsibilities: - Technology Transfer: • Assist in managing the technology transfer process for new products and process for new products and processes from R&D to commercial production. • Collaborate with cross-functional teams including R&D, Manufacturing, Quality and Regulatory Affairs to facilitate successful technology transfer within specified timelines and quality standards. • Contribute to the development and implementation of strategies to mitigate risks associated with technology transfer process. Process Engineering : • Support process engineering activities aimed at optimizing manufacturing processes for efficiency, scalability, and cost effectiveness. • Participate in identifying opportunities for process improvements, conducting studies, and implementing solutions to enhance product quality and yield. • Assist in providing technical guidance to the engineering team to drive continuous improvement initiatives. Compliance and Documentation: • Assist in ensuring compliance with regulatory requirements and industry standards throughout technology transfer and process engineering activities. • Review documentation related to technology transfer, process optimization and validation protocols as needed. Cross Functional Collaboration : • Work collaboratively with other departments to facilitate smooth technology transfer and process improvements. • Support Quality Assurance and Regulatory Affairs in regulatory filings and inspections as required. Leadership and Development: • Support Head of MSTG in providing leadership, mentoring and guiding to the MSTG team, promoting a culture of innovation, teamwork and continuous learning. • Identify training needs and development opportunities for team members to enhance their skills and capabilities. Interested candidates forward resume on anuverma@scllifesciences.com or Whats app/ call on 9988339860.

Role & responsibilities - Responsible for the availability of raw materials as per lab requirements -To analyse quality results and discuss the experimentation plan with Research Incharge. - Understand the safety aspects of all reactions and chemicals to be used - Ensure the setup ( reaction assembly, distillation, filtration, reaction work-up, crystallization) as planned - Carry out reaction process as per the provided plan, get the analysis done of raw material , in process reaction intermediate and product - Record all observations and give suggestions for improvement - Ensure proper housekeeping of the lab - Maintain highest safety practices while working by using required PPEs (Personal protective equipment) - Maintain the log sheets of all the experiments regularly with critical observations and feed the data into Electronic Lab Notebook (ELN) - Stack of all the chemicals & glassware as per 5S (sort, set-in-order, shine, standardize, sustain) - After reaction completion, decontaminate the glass apparatus and give for further cleaning. - Segregate effluents as per the lab system Desired Candidate Profile Minimum M.Sc. Organic Chemistry or equivalent 2-7 Years of experience is required 1 year Stability in current company Only from Chemical Company

Research In API - Intermediate And Bulk Drugs Doing Lab trials as per Instructions Analysis of results Follow safety rules and regulations Maintain data of all the Lab Experiments Preventive maintenance and improvement activities Statutory compliance Required Candidate profile M. Sc or Ph. D with Chemistry 2 to 9 years of Experience in API , Intermediate , Dyes , Pigment , Specialty Chemical , Fine chemical Etc. Reporting to Local Unit Head - Research And Development

Technology Transfer professional to support seamless scale-up and integration of new products/processes from the production floor. The role bridges development and manufacturing, ensuring process understanding, compliance, and efficiency.

Practice 5S, Housekeeping And EHS Compliance Performing Scale-up, Operations And Allocate Responsibilities To Operators Preparation And Maintenance Of SOP, HAZOP And Operations Related Documents Submission Of preblend Samples to R&D - QC Approval Required Candidate profile BE - ME - Chemical From Reputed Institute Candidate Should Have Worked In Pilot Plant Deep Knowledge Of Troubleshooting Ready To Work In Shift Capable To Allocate Responsibility To Operators

Role & responsibilities Knowledge about chemical reaction and chemical compounds. Awareness about R&D lab Instruments and Glassware. Setting up lab experiment assembly like reaction, distillation, vacuum distillation, separation, etc. Ensuring experiments are carried out safely and carrying out risk assessments. Maintain complete records of experimental results and analysing data of experiments. Optimize reaction conditions and troubleshoot technical issues. Ensure consistency and repeatability of process to get acceptable yield and quality. Preferred candidate profile M.Sc. in Chemistry having 2-5 Years Experience in R&D Synthesis having Chemical and Pharmaceutical Industry having problem-solving and decision-making skills, Strong analytical and organizational skills . Additional Information: At Avid Organics, we believe that we can achieve our mission to enhance value creation for our stakeholders only through the quality and commitment of our people. We continuously strive to unleash the potential of each individual. We leverage human capital for competitiveness by nurturing knowledge, entrepreneurship, and creativity. These strengths help us compete successfully in a global business environment and exploit emerging opportunities. We reward the will to succeed and the desire to compete with the best in the world. Our employees are intellectually stimulated and given the freedom to make their own decisions, driving our growth through innovation and experimentation. Apply Now! :- hr@avidorganics.net Visit our website or contact us at https://www.avidorganics.net

Practice 5S, Housekeeping And EHS Compliance Performing Scale-up, Operations And Allocate Responsibilities To Operators Preparation And Maintenance Of SOP, HAZOP And Operations Related Documents Submission Of preblend Samples to R&D - QC Approval Required Candidate profile BE - ME - Chemical From Reputed Institute Candidate Should Have Worked In Pilot Plant Deep Knowledge Of Troubleshooting Ready To Work In Shift Capable To Allocate Responsibility To Operators

Area of work: Batteries for long duration energy storage and green hydrogen by electrolysis. Job Purpose Technology evaluation; Support to business opportunities and Upcoming Assets Scan technologies for – batteries for energy storage, electrolyser technologies for hydrogen. Propose applications Scouting technology for CO2 conversion to valuable chemicals, propose demo application. Evaluate business cases, carry out lifecycle analysis. Support Technology development & deployment Establish prototype testing and application labs, collaborate with R&D. Propose strategic engagement, work with OEMs Technology deep dive – redox reaction kinetics, electrode materials, mass transport, electrolytes, separators Scale up from Lab to Pilot to Commercial sizes. Develop energy storage applications like round the clock power. Integration with renewable energy Knowledge of various battery technologies, understanding technical advantages and limitations thereof of applications in energy storage Knowledge of electro synthesis processes viz. water electrolysers, etc. and Balance of plant (BOP) of these processes Hands on experience in batteries/ electrolysis is a added advantage Education Required Bachelors or Master's Degree in Chemical Engineering from premium institute Experience Required Relevant industrial experience (10 years) with good technical background and good communication skills. Candidates should have exposure in areas of Hydrogen generation through Electrolysis

Role & responsibilities • To receive and understand the technology from FnD dept. • To design optimisation for process parameters & participate in the trials at R&D. • To transfer the technology from R&D to receivers site for the respective product. • To monitor the TT demo / exhibit/scale up and optimization batches. • To review the technical information sheet, product detail, raw material/accessories/ equipment requirement for plant trial/SU/Exhibit batches. • To propose and fix the batch size i.e. of the Demo, Scale up, Exhibit and Commercial based on Equipment Capacity/Qualification, Scale Up factor calculations & annual requirements. • To get involved and observe in the TT demo batch with F&D. • To take scale up batch at manufacturing locations and prepare scale up batch protocol, Scale Up Reports, MFC, Sampling Protocol, Risk Assessment etc. • To take the exhibit batches at the manufacturing locations and take care for its trouble shooting. • To prepare the summary reports. • To perform investigation for Deviation/ OOS/ OOT observed during SU/EB at plant. To prepare agency query responses.

Sun Pharmaceutical Industries Limited WALKIN DRIVE @ BARODA Function : MS&T - Injectable Experience : 1 to 6 years Qualification : B.Pharm/M.Pharm Job Location : Halol - Gujarat Date of Interview : 11th May 2025 || Time : 9.30 am - 1.00 pm. Venue of Interview : Sun Pharmaceutical Industries Limited, Near Akshar Chowk, Tandalja Road, Vadodara - 390012 Job Description: Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to btain the desired quality. Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance. Handling & Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting To ensure that the Packing operations or activities are carried out on timely. To monitor & prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing & dehydrogenation, CIP/SIP System, PLCs, instruments etc. Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches & their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.

We have been hired by a highly reputed and fast growing Pharma company to hire a "DGM - Formulation & Development' to be based at their plant located at Aurangabad . Details of the position are mentioned below: Role & responsibilities: Literature search/study and to prepare development trials strategies. Pre formulation study execution. Market/Innovator/reference product characterization. Execution and documentation of trial batches for prototype formulation development. Execution and monitoring of development stability studies. Execution of process optimization/scale-up batches. Technology transfer activities at site. Preparation/review of documents like BOM, MFR, compatibility study protocol & report, stability study protocol and report, PDR, etc as per requirements. Co-ordination with production, other relevant cross-functional departments/teams. Having experience/exposure of formulation development of solid oral, liquid, dry syrup, etc dosage forms aimed for ROW and domestic market. Should possess experience in handling various equipment like RMG, FBD/FBP, compression machine, roller compactor, coating machine, etc. Preferred candidate profile : Educational Qualification: M. Pharm Experience: 12 - 20 Years of relevant experience in a leading Pharma Company. Good Communication & Presentation skills Those of you whose profile matches the above mentioned description and would like to apply for this position shall forward their updated CV to sudhirvinayak@gmail.com In case of a query, please feel free to speak to the undersigned: Sudhir Vinayak Director, Pharma Placements Inc. Mobile number: 98202 34987

Research In API - Intermediate And Bulk Drugs Doing Lab trials as per Instructions Analysis of results Follow safety rules and regulations Maintain data of all the Lab Experiments Preventive maintenance and improvement activities Statutory compliance Required Candidate profile M. Sc or Ph. D with Chemistry 2 to 9 years of Experience in API , Intermediate , Dyes , Pigment , Specialty Chemical , Fine chemical Etc. Reporting to Local Unit Head - Research And Development

Role & responsibilities a. Having experience for EB /PV data compilation and report preparation and review. b. Having experience for Executed document (BMR& BPR) review and compliance in coordination with validations requirement. c. Having exposure for hold time study data review and report compilation. d. Having exposure for sampling strategy of bulk and finished product in case of exhibit and commercial launch batches. e. Coordination with stability /micro/QC validation /production team for data collection and compliance as per validation requirement. f. Having exposure for QMS for validation recommendations closure and revision for routine commercials. g. Having exposure for document readiness and submission for product filing to regulatory department or client