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8.0 - 12.0 years

0 Lacs

maharashtra

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Manager - R & D (Rapids) Experience : 8 - 10 years Functional Area : Research and Development Qualification : MSc. Work Location : Mumbai - Maharashtra Job Description : 1) Design and Development of Rapid Products. 2) Design and Development of ELISA Products. 3) Document preparation for Regulatory requirements. 4) Technology transfer to production department. 5) Team development and training for new product designs.,

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3.0 - 5.0 years

6 - 10 Lacs

Bengaluru

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Educational Bachelor of Engineering Service Line Infosys Quality Engineering Responsibilities A day in the life of an Infoscion As part of the Infosys consulting team, your primary role would be to actively aid the consulting team in different phases of the project including problem definition, effort estimation, diagnosis, solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys, information available in public domains, vendor evaluation information, etc. and build POCs You will create requirement specifications from the business needs, define the to-be-processes and detailed functional designs based on requirements. You will support configuring solution requirements on the products; understand if any issues, diagnose the root-cause of such issues, seek clarifications, and then identify and shortlist solution alternatives You will also contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Preferred Skills: Technology-ETL & Data Quality-ETL - Others

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2.0 - 3.0 years

7 - 10 Lacs

Bengaluru

Work from Office

Educational Bachelor of Engineering Service Line Enterprise Package Application Services Responsibilities A day in the life of an Infoscion As part of the Infosys consulting team, your primary role would be to actively aid the consulting team in different phases of the project including problem definition, effort estimation, diagnosis, solution generation and design and deployment You will explore the alternatives to the recommended solutions based on research that includes literature surveys, information available in public domains, vendor evaluation information, etc. and build POCs You will create requirement specifications from the business needs, define the to-be-processes and detailed functional designs based on requirements. You will support configuring solution requirements on the products; understand if any issues, diagnose the root-cause of such issues, seek clarifications, and then identify and shortlist solution alternatives You will also contribute to unit-level and organizational initiatives with an objective of providing high quality value adding solutions to customers. If you think you fit right in to help our clients navigate their next in their digital transformation journey, this is the place for you! Additional Responsibilities: Ability to work with clients to identify business challenges and contribute to client deliverables by refining, analyzing, and structuring relevant data Awareness of latest technologies and trends Logical thinking and problem solving skills along with an ability to collaborate Ability to assess the current processes, identify improvement areas and suggest the technology solutions One or two industry domain knowledge Technical and Professional : Primary skills:Technology-Java-Java - ALL Preferred Skills: Technology-Java-Java - ALL

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3.0 - 6.0 years

10 - 20 Lacs

Hyderabad

Work from Office

Job Summary We are seeking a dynamic and experienced Formulation Scientist in Injectable division for designing and development of formulation process, ensuring quality by design (QbD) implementation, scaling up for manufacturing of batches, coordinating manufacturing readiness, overseeing plant execution, and facilitating seamless technology transfer. Roles & Responsibilities You will be responsible for end to end Formulation development of Inhalation including development, execution, filing and approval. You will be responsible to co-ordinate closely with analytical team to devise effectiveProof 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 technologytransfer 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 documentsfor 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 materialsand ensure development studies are performed related to regulatory and internal system requirements. 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 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/#!/

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5.0 - 9.0 years

3 - 8 Lacs

Hyderabad

Work from Office

Dear Applicants, Greeting from Biophore India pharmaceutical Pvt Ltd, We have opening for Formulation R&D Department (OSD - Injectable) Position : Executive or Sr Executive Experience : 4 - 7 Yrs Job Description: 1) Candidate must have knowledge Prototype & Product Development. 2) Must have Literature Search. 3)Scale-up Batches, Exhibit Batches, DOE Experiments. 4) PDR Preparation & Development related documentation. 5) Experience in US ,EU Markets. 6) Preparation of documents form development stage to Technology Transfer Stage. Preparation and Review of SOP,S related to formulation R&D. 7) Good Communication Skills. Ref to Friends or colleagues. Please Share me update resume: careers@biophore.com Total Exp: Current CTC: Exp CTC : Notice Period: Designation:

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4.0 - 9.0 years

5 - 15 Lacs

Ahmednagar

Work from Office

Accountabilities: Participate in witnessing / Technology absorption of process & operations during batches at Lab / Kilo Lab / Pilot Plant and accordingly implement it for smooth transfer of technical knowhow for scale up batches at Plant scale. Lead the CFT during technology transfer at plant scale. Planning and executing the plant campaign to meet the delivery as per time and quality commitment. Job Descriptions:- Technology Transfer of products (APIs & Intermediates) from R&D, One site to another site. This includes Facility evaluation and retro fitment of new products and cost reduction products for exhibit campaign at In house as well as at Contract manufacturing facilities & accordingly arranging for modification costing and facilitate approval of budget, follow-up for modifications & plant readiness. Preparation of all documents related to project and coordination with all CFT members to expedite work to meet delivery timelines. Involvement during Pilot scale-up of new products for identification and optimization of critical operations to ensure smooth operations and proper hardware identification during Scale-up/exhibit batches. Complete planning of RMs for required API quantity and facilitate in procurement activities. Plan for analysis on receiving at the locations Leads HAZOP study and implementation of its recommendations for specific process requirements with respect to safety, during the plant campaign. Exhibit campaign planning, scheduling and execution of development and exhibit batches at both in house and contract manufacturing locations to meet the delivery timelines with desired yield and quality. Coordination with respective CFT members including CRD, TD, AD, DRA, GMS, Production, QA and QC before and during the course of campaign so as to minimize delays and ensure that product delivery timelines are met. Assist in resolution of unexpected issues that crop up during technology transfer. Process improvement (Cost reduction, Quality improvement; Capacity debottlenecking, troubleshooting of APIs / Intermediates). This includes the Identification of projects & coordination with all stake holders for project scale up. To study the unit operations in plant for identifying the improvement areas (Power, Energy, EHS, waste minimization, Efficiency Improvement etc.) and giving solutions for the same. To ensure GMP and EHS compliance in the area of work.

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6.0 - 10.0 years

8 - 11 Lacs

Dahej

Work from Office

Role & responsibilities To observe lab experiments during lab demonstration at optimization stage and suggest Negative experiment based on plant equipment and feasibility. Preparation of process summary, volume calculation, Mass balance, utility load, effluent load and costing. To identify and propose new ideas & technology to improve process efficiency, smooth unit operation/unit processes and effective utilization of resources To identify recovery and reuse of solvents. Ensure right equipment selection as per process requirement. Suggest required modification in equipment as per process requirement. Support the external job work activity to achieve desired yield & quality. Coordinate with Cross Function Department Like Production, R&D, maintenance and QA to smooth line the technology transfer. Handle equipment safely during operation, maintenance, and shutdowns by following established procedures. Collaborate with cross-functional teams to implement process safety improvements through scale up and capacity enhancement initiatives. Perform risk assessments to evaluate the severity of identified hazards and develop mitigation strategies. Conduct HAZOP studies to identify potential hazards in processes and equipment.

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8.0 - 13.0 years

12 - 22 Lacs

Tuni, Hyderabad, Kakinada

Work from Office

Role & responsibilities Prepare and implement MPRs / SOPs for shop floor operations. Process optimization and capacity debottlenecking using mass/energy balances. Lead continuous improvement in yield, safety, quality, and waste reduction. Commission new products / projects: prepare BFD/PFD/P&ID/MPR/SOPs and DCS updates. Act as a process expert and trainer for production staff. Analyze utility and raw material variances; prepare management reports. Coordinate with Engineering for preventive maintenance. Investigate incidents and support operations troubleshooting. Perform additional duties assigned by the HOD. Preferred candidate profile Bachelor's / Masters in Chemical Engineering. In-depth understanding of chemical/non-chemical hazards, BEP, and basic engineering. Strong HSE & Quality systems knowledge. Skilled in DCS, automation, multistage synthesis, and large-scale chemical production. Proficient in hazard analysis and stakeholder engagement.

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2.0 - 6.0 years

5 - 13 Lacs

Tuni, Hyderabad

Work from Office

Role & responsibilities Develop PFDs, P&IDs, mass & energy balances. Optimize process parameters and reduce cycle time. Select and size process equipment (Reactors, Heat Exchangers, Filters, etc.) Support commissioning, risk assessments, and DCS changes. Prepare SOPs/MPRs and support troubleshooting. Drive process improvements while ensuring HSE & quality compliance. Perform additional duties assigned by the HOD. Preferred candidate profile Bachelor's / Masters in Chemical Engineering. In-depth understanding of chemical/non-chemical hazards, BEP, and basic engineering. Strong HSE & Quality systems knowledge. Skilled in DCS, automation, multistage synthesis, and large-scale chemical production. Proficient in hazard analysis and stakeholder engagement.

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7.0 - 12.0 years

10 - 14 Lacs

Vadodara

Work from Office

Sr Technology Transfer Specialist for client in Nandesri, Vadodara. 6 days working.Lead the transfer from R&D to manufacturing. Compliance with standards, collaboration with various teams.

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1.0 - 6.0 years

3 - 8 Lacs

Navi Mumbai, India

Work from Office

Job Title: Research Associate Department/Function: BRL Reporting To: DGM Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working Job Summary: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for all markets. Deliverables involves, but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities. Responsible for independent planning and execution of experiments. Techniques include, but not limited to Chromatography, Electrophoresis, Spectrophotometric-Colorimetric assays and Higher order characterization for Biotherapeutics. Required Skillsets: Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc is required. Preferred to have some working knowledge of biosimilars. The following are considered strong assets: Manufacturing industry experience, JAVA stacks experience. Maintain effective and cooperative working relationships with administrators, staff, users, project consultants. Good to have : Integration with Non SAP systems via RestAPI, SOAP API , SFTP etc. Experience Required: Experience of working on biotherapeutic proteins like Cytokines, Fc fusion peptides/proteins and/or Monoclonal antibodies is required Method Development and/or routine analytical support experience with biosimilars is a must Understanding of analytical deliverables involving CQA, QTPP, Biosimilarity, Forced degradation studies, Specifications setting, etc. is preferred. Accountability: To perform assigned analytical activities by following established systems and procedures. To maintain target dates for analytical activities. To maintain data integrity during analysis. Preparation and review of reports and contribution in troubleshooting efforts required for Instrumentation Communicate effectively with other team members and teams regarding the analytical data. Education: Min. Qualification Required - M.Sc. / M.Tech. - Biotechnology / Microbiology Experience: Minimum 6 months- 2 years

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5.0 - 10.0 years

4 - 9 Lacs

Jammu

Work from Office

Job Title: Head-R&D and Formulations Location: Jammu Experience: Minimum 5 years in Nutraceuticals & Herbal Product Formulation Industry : Nutraceuticals & Herbal Manufacturing Salary: Negotiable (No bar for the right candidate) Job Summary:- We are looking for a seasoned professional to lead our Research & Development and Formulation department for Nutraceuticals and Herbal products. The ideal candidate must have hands-on experience in new product development, formulation trials, process optimization, and regulatory documentation. Key Responsibilities:- • Develop stable and cost-effective formulations (tablets, capsules, protein powders, syrups, ointments, granules, etc.). • Conduct product trials and pre-formulation studies. • Ensure all formulations comply with FSSAI and AYUSH regulations. • Handle technology transfer to the manufacturing unit. • Prepare and review product development documents (MFC, BMR, BOM, etc.). • Lead & coordinate with QA/QC, Production, Regulatory, and Purchase teams. • Work on cost-saving reformulations and process improvements. Required Skills:- • Strong knowledge of Nutraceuticals and Herbal formulations. • Experience in stability studies, tech transfer, and regulatory support. • Familiar with FSSAI, AYUSH, and industry documentation practices. • Team leadership and cross-functional coordination. Qualifications:- • M. Pharm / B. Pharm or equivalent in a relevant field. • 5+ years of R&D experience in Herbal/Nutraceutical manufacturing. To Apply:- Email your cv to hr@adexapharma.in or 7827305246

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1.0 - 6.0 years

4 - 9 Lacs

Navi Mumbai, India

Work from Office

Job description - Research Associate (Protein Chemistry laboratory) 1. Process development, scale-up and transfer: (Downstream) Undertake on-going referencing and literature reviews and provide strategic inputs to projects at all stages Conduct lab experiments as per the shortlisted methodologies in order to develop & finalize purification processes for various recombinant therapeutic products. Provide own inputs and insights to optimize/improve process Provide samples to analytical labs for testing, collect and file reports of analysis, compile the data and do data analysis for conclusion of experiments Support plant activities as per need Present data in project review meetings Prepare process development report and technology transfer documents Participate in at-scale demo batches and handover as part of technology transfer Jointly monitor purification process at production facility and resolve any queries that may arise during production 2. Materials and equipment management: Oversee installation of new equipment and attend demos Maintain all IQ/OQ/PQ documents Ensure scheduled and breakdown maintenance by coordinating with maintenance team Create and maintain all maintenance/ repair logs Support management of chemical, consumables: o Transfer/store as per set norms o Engage in technical discussions with vendors in order to suggest suitable vendors o Maintain material logs and calculate shortfalls (for order placement) o Post materials required onto SAP 3. Regulatory and compliance: Accurately capture all lab experiments in laboratory notebooks in real-time Adhere to regulatory, SOPs and safety guidelines for all processes Modify SOPs in own area of work Ensure timely closure of regulatory queries by conducting and documenting lab experiments Ensure data integrity in all respects 4. Learning and improvement Attend all mandatory trainings Take initiative to provide inputs (based on expertise/interest) to other on-going projects Take initiatives for self-development and update self on recent developments in own area of work Take initiative to train fresh RAs upon induction or guide them with select lab processes (basis expertise) 5. Compliance management Ensuring GDP compliance Ensuring CC/ IQ/OQ/PQ/CSV of new instrument Ensuring calibration/PM/AMC of equipment Be audit ready and prepare audit responses as per audit points Lab cleanliness, lab maintenance

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3.0 - 8.0 years

5 - 15 Lacs

Roorkee, Gurugram

Work from Office

Urgent hiring for Research Scientist / SRA Formulation R&D (OSD) for Roorkee & Gurgaon location Location: Roorkee Department: Formulation & Development (F&D) Industry: Pharmaceuticals OSD & Liquid Job Description: We are hiring a Research Scientist – Formulation R&D for its Roorkee facility . The candidate must have strong experience in formulation development, technology transfer , and scale-up activities for regulated and semi-regulated markets . Key Responsibilities: Execute and support formulation development and scale-up for OSD products Conduct technology transfer from R&D to production Prepare and review MFC, MFR, PDR , and tech transfer documentation Develop and optimize exhibit and validation batches Ensure compliance with regulatory standards for global markets Coordinate with cross-functional teams including QA, Production, and Regulatory Knowledge of bioequivalence/bio study is desirable (not mandatory) Requirements: M.Pharm with specialization in Pharmaceutics (mandatory) 3–6 years of experience in Formulation R&D (OSD) Must have experience working for regulated and semi-regulated markets Strong documentation and project execution Apply at: anupriya.1@walterbushnell.com WhatsApp CV to: 9650111639

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8.0 - 12.0 years

10 - 15 Lacs

Visakhapatnam

Work from Office

To lead & support process development, Scale Up, Process Engineering, Tech Services troubleshooting & optimization of chemical processes from laboratory to commercial plant scale, ensuring safety, cost-efficiency, Documentation & Compliance. Required Candidate profile BE/B.Tech/M.Tech - Chemical Engg. Full Time with 8+ years of experience specialty/fine Agro, pharma intermediates Knowledge of Scale Up, Process Engineering, Technical Services Perks and benefits GTLI/GPA/GMC/Transportation/Canteen

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10.0 - 20.0 years

15 - 25 Lacs

Roha

Work from Office

Provide Technical Expertise, Manufacturing Excellence, Finished products CPK & CPI, Test production of new products, Analyze & Define, Support Manager regarding compliance, regulations and policies. Coordinate & follow up plant process improvements. Required Candidate profile B Tech (Chemical/Mechanical) Min 8 years of experience as a Site Process Engineer for Chemical Manufacturing plant Exp in project management Excellent Communication Skills

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10.0 - 15.0 years

10 - 17 Lacs

Dahej

Work from Office

Resp to establish & innovate continuous flow chemistry/FBR from R&D to commercial Review & update Material & Energy balance, P&IDs, equipment layout & elevation drawings Technology transfer to commercial level from 1kg catalyst to1000 Kg. catalyst Required Candidate profile Knowledge of Continuous Flow Chemistry, Fixed Bed Reactors, Zeolite Synthesis,HAZOP, P&ID, PFD, material & energy Balance Ability to conduct tech analyses & research with safe & cost effective methods

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8.0 - 13.0 years

15 - 20 Lacs

Mangaluru

Work from Office

Experience in Process Optimization, quality control, Safety compliance, data analysis, Continuous improvement, Project management, documentation Scaleup & technology transfer for different processes from R&D & finally to Commercial plant Required Candidate profile Strong knowledge of chemical manufacturing processes & equipment 8-10 years of experience as a Process Engineer in the specialty chemicals/ Pharma/ Aroma Chemicals industry.

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10.0 - 17.0 years

15 - 20 Lacs

Mangaluru

Work from Office

Experience in Process Optimization, quality control, Safety compliance, data analysis, Continuous improvement, Project management, documentation Scaleup & technology transfer for different processes from R&D & finally to Commercial plant Required Candidate profile Strong knowledge of chemical manufacturing processes & equipment 8-10 years of experience as a Process Engineer in the specialty chemicals/ Pharma/ Aroma Chemicals industry.

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3.0 - 6.0 years

3 - 8 Lacs

Hyderabad

Work from Office

We have requirement for OSD - FR&D with an experience of 3 to 6 Years: Skills Required: Technology Transfer. Plant visit as Technology Transfer Oncology Experience Exposure on API Products, General Exposure on OSD. Work Location: CRAMSN Research Park ( R&D Center), Pashamylaram, Patancheru, Hyderabad. Interested can share there CV's to mail: manishankar.dadi@msnlabs.com

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5.0 - 6.0 years

6 - 10 Lacs

Chandigarh

Work from Office

Modification and improvement in machine parts. Introduce new technology. Machine setting as per product requirement. Study design of products for making improvements. To support production by making process improvement, lean manufacturing. Should be able to read the engineering drawings and have knowledge about fits procedures. Job Specifications: Diploma/ Degree in Mechanical 5-6 years of relevant experience in a reputed firm Experience in SAP Excellent Communication Work experience in Production/ Production Engineering/ Technology Transfer is preferable.

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2.0 - 6.0 years

2 - 5 Lacs

Himachal Pradesh, una

Work from Office

Job description Primarily responsible for supervision of Formulation & Development area and to monitor / Supervision and control over the operator / assistant operator in their designated premises at the site. Literature search, patents search and review the same as per product requirement. Innovator/ market sample characterization. Day to – day execution planning of F&D trials for Domestic / ROW & other regulatory markets. Responsible for characterization, lab scale development, scale up, technology transfer and exhibit batches. Planning of pre – formulation studies for the Product development. Execution of development trials, achieving desired critical quality attributes, and manufacturing the stability batches. Improvement in existing formulations and possibility of new dosage forms. To ensure the timely completion of the assigned products Formulation Development and Technology Transfer. Coordination with analytical department for routine analysis of formulations and development. Preparation of technical documents like product development reports, master formula record and technology transfer documents.

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4.0 - 5.0 years

1 - 2 Lacs

Ranchi

Work from Office

You have to oversee projects and ensure that the work is execute as per approved specifications, quality and standard. The core role and responsibilities are:- Should have knowledge of all type of test, testing equipment/machine. Operating standard construction material laboratory testing equipment. Performing analysis or calculations to check accuracy of test data. Accurately performing various construction material tests in accordance with applicable standards. Cleaning, maintaining and calibrating equipment. Preparing all QC Laboratory documents like work procedures, ITP, QAP, Checklist, formats required for carrying out project specific activities and testing as per project specifications and codes of practice. Coordinating with contractors for the field-testing, pre and post concrete inspection and obtaining approval. Knowledge of civil/soil/water engineering principles, practices and methods, environmental regulations, workplace safety and personnel management. Maintaining the lab record of reading and field observations, for calculating and reference purposes. Excellent knowledge of Ms Office, AutoCad, etc Effective verbal and written communication skills Competence in handling simultaneously occurring tasks and smaller projects. Excellent organizational skills and team working abilities. Should have idea of quality of construction materials. Minimum Requirements Diploma in Civil Engineering with 4-5 years of relevant experience in Highway and Bridge Projects. Prior experience in large scale highway and bridge projects would be an added advantage

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12.0 - 15.0 years

12 - 15 Lacs

Gurugram

Work from Office

Job Description OBJECTIVE: To maintain optimum quality in Formulation research and generation of quality data in Formulation Development department to support the development of a safe and quality product. RESPONSIBILITY : Formulation development of oral solid, Liquid, Parenteral and semisolid products by QbD Approach for Regulatory & ROW markets. To handle a team of 10 to 15 team members. Technical assessments of projects (Screening of Project, pipeline) Scientific literature Search and patents evaluation for strategic development. Technical screening of API, RM, PM sourcing for F&D activity. Formulation Development Strategy preparation with design around opportunities & developing Bio-equivalent products. Provides support and guidance in scale up/Technology transfer activities for new Formulation development Projects Assisting and ensuring timely completion of development activities at in-house R&D lab, (Pre-formulation studies, formulation development, stability studies etc.,) Guiding the F&D teammates to timely complete the development activities. Review and summarizing technical data for milestone assessments. Performing trending and monitoring of critical quality attributes/critical process parameters to maintain product quality. Responsible for review of analytical data (e.g. dissolution, assay, related substances, Blend uniformity, content uniformity etc.) Supporting regulatory team in health regulatory submission and query response. Maintain Evolet Healthcare Policy on Quality, Safety and Efficacy Value.

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1.0 - 6.0 years

2 - 4 Lacs

Bavla, Ahmedabad

Work from Office

Role & responsibilities Responsible for Pre-formulation studies for lab formulation development trials of solid orals, Oral Liquid, injectable, products, and Nutraceuticals product. To design strategy for projects through literature surveys. Respective API characterization, excipients characterization, drug and excipient study and its ratio. Worked on different manufacturing strategies for the development of products. To evaluate product for stability in manufacturing, monitor and review the stabilized batches. To study on existing formulations. Responsible for co-ordination, execution and monitoring of scale up activity, Responsible for Trial batches, Scale up batches, Optimization batches, Exhibit batches. Co- ordination with all cross-functional teams. TT sites and LL Sites To design/assist/support/ review for documents such as SOP, LNB, QQ, Risk assessment, PDR, MFR, Scale up BMR, stability protocol, qualification, validation documents, change controls, deviations, investigations and CAPAs etc. Preferred candidate profile

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