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4.0 - 9.0 years
5 - 13 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.
Posted 2 weeks ago
5.0 - 10.0 years
6 - 12 Lacs
chennai
Work from Office
Role: Quality Manager Medical Devices / Pharmaceutical Products Location: Chennai, Tamil Nadu Job Description: We are seeking a skilled Quality Manager to join our team in the medical devices/pharmaceutical sector. The position requires strong experience in quality management systems, regulatory compliance, and cross-functional collaboration across development and manufacturing. Key Responsibilities: Support multiple quality projects across development and commercialization stages Maintain and enhance QMS in line with ISO 13485, 21 CFR Part 820, EU MDR Review technical documentation (DHF, risk files, validation records) Assist in regulatory submissions (510(k), CE marking) Collaborate with cross-functional teams to embed quality throughout the product lifecycle Lead quality activities in design transfer and process validation Apply risk management principles per ISO 14971 and ICH Q8/Q9/Q10 Support internal/external audits, CAPA, and change control Liaise with manufacturing partners for audit/inspection readiness Required Skills: Strong knowledge of ISO 13485, 21 CFR Part 820/210/211, EU MDR Experience with regulatory documentation and submissions (510(k), CE marking) Tech transfer or scale-up support is desirable Excellent communication and interpersonal skills Ability to work effectively in dynamic, team-based environments Experience: 48 years in quality or manufacturing roles within the medical device or pharmaceutical industry Education: Bachelors Degree in Science or Engineering (mandatory) Preferred Industry: Medical Devices, Pharmaceuticals, Biotechnology Please apply here for faster responses from HR Team- https://forms.gle/H9AcbJSXbAw65ux99
Posted 2 weeks ago
6.0 - 11.0 years
11 - 19 Lacs
noida, greater noida, delhi / ncr
Work from Office
Job Description Are you a passionate scientist with a strong background in development, tech transfer, scaleup activity, evaluating the process? Join our innovative team at our state-of-the art Global R&D Centre , where your expertise will contribute to the development of life-changing therapies. Key Responsibilities What Youll Be Doing: Works within standard operating procedures and/or scientific methods. Work closely with CRD, ARD and PRD teams to ensure project completion within defined timelines. Equipment selection and sizing- Ensure the selected equipment for scale up should match the process requirement. Ensure the availability of scale up study as per guideline and within agreed timelines. Coordinate with GMP teams to enable Technology Transfer to manufacturing. Ensure the completion of nGMP and GMP campaign as per agreed timelines. Ensure the EHS compliances at lab. Generating required Reports. Responsible for completion of tasks by CFT; execution of batches at plant. Work closely & coordinate with all internal and external stakeholders to ensure smooth technology transfer to selected commercial sites. Responsible for addressing operational/ technical process related challenges by discussing with supervisor/ CFT. Understanding of cGMP requirements. Competencies Required Follow established Procedure and methodologies to develop solution to solve scientific / technical problem of limited scope Works independently with little guidance Responsible for delivery of project tasks Uses established process to solve problems Complete understanding of scientific/ technical principles, theories and concepts in the field. Understanding of Process Safety principles. Interested candidate can share their profile on jasleen.kaur@tapi.com or connect on 8076954558.
Posted 3 weeks ago
5.0 - 10.0 years
5 - 10 Lacs
ahmedabad
Work from Office
Job Description: Formulation Development candidate - 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 OSD 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. 5 to 10 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.
Posted 3 weeks ago
7.0 - 11.0 years
0 Lacs
indore, madhya pradesh
On-site
The ideal candidate will be responsible for leading end-to-end upstream fermentation operations, which includes tasks such as media preparation, seed culture development, fermentation scale-up, and harvest. You will be required to optimize classical microbial fermentation processes to achieve high cell density and metabolite production using various microorganisms like bacteria, yeast, or fungi such as E. coli, Bacillus, Saccharomyces, and Streptomyces. It will be your duty to ensure that production targets in terms of volume, yield, quality, and timelines are consistently met. In cases of upstream process deviations, contamination, or yield drops, you will be expected to troubleshoot effectively. Collaboration with R&D and Tech Transfer teams will be essential for the successful scale-up and commercial execution of new strains or processes. You will also be responsible for evaluating and implementing process improvements, automation, and cost-saving initiatives. Accuracy in documentation, including batch records, SOPs, deviation reports, and change controls, will be crucial for this role. In terms of compliance and quality, you will need to ensure that all operations adhere to cGMP, regulatory, and EHS requirements. Supporting regulatory audits and customer inspections, as well as participating in investigations and implementing CAPAs related to upstream activities, will be part of your responsibilities. As a leader, you will be required to mentor and develop a team of production officers, operators, and shift engineers. Training team members on fermentation operations and GMP guidelines will be essential. Close coordination with downstream, QA, maintenance, and warehouse functions will also be necessary to ensure smooth operations. If you are interested in this position, please reach out to jai.mirchandani@symbiotec.in for further details.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
pune, maharashtra
On-site
The role involves synthesizing and purifying assigned molecules and conducting experiments. You will be responsible for the process development activities of the assigned molecule, as well as supporting the scaling up of developed processes in pilot plants and large-scale manufacturing processes. Additionally, you will provide complete support for Tech Transfer activities by closely collaborating with cross-functional teams. Your role will also include adding value to processes through innovation. It is essential to understand and analyze reports received from the Analytical department, including NMR, Mass Spectrum, IR, HPLC, GC, etc. You will partner with the Analytical Development Laboratory (ADL) to process samples for analysis as per the requirement.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
Job Description Under the general supervision of the lab team leader, you will independently perform routine scientific research tasks using standard techniques, procedures, and equipment. You will adapt, optimize, or develop new methods and procedures, actively contributing to the technical solution finding process. It will be your responsibility to propose solutions and discuss them with the manager, showcasing your engineering and tech transfer proficiency. Additionally, you will assist and support the R & D team and cross-functional team in the scale-up of new product technology. Troubleshooting and improving existing processes will also be a part of your role. You will summarize and document results in the lab journal and prepare technical reports. Maintaining a clean working laboratory environment and ensuring suitable working equipment is also crucial. General lab assignments such as raw material inventory review and lab instrument maintenance will be assigned to you. It is important to comply with regulations concerning safety, health, and the environment. If you are looking for a dynamic role where you can contribute to scientific research and innovation, this position offers the opportunity to work closely with a dedicated team in a challenging yet rewarding environment. Job Identification: 7675 Job Category: R & D Posting Date: 03/25/2025, 01:21 PM Degree Level: Master's Degree Job Schedule: Full-time Location: Plot No.D-2/11/A-1 GIDC, Phase II, Bharuch, Gujarat, 392130, IN,
Posted 1 month ago
12.0 - 15.0 years
0 Lacs
Mumbai, Maharashtra, India
On-site
Job Responsibilities: 1) Biochemical Reagents development, assay developments, trouble shooting. 2) Exposure to handle sophisticated Biochemistry automated Analyzers 3) ISO Certification handling & know-how of existing Govt. norms. 4) License documentation handling. 5) Execute Research Projects 6) Ensure smooth tech Transfer 7) Preparation of documents for regulatory approvals of developed assays. Candidate Profile: Qualification : M.Sc (Biochemistry) / PhD (Biochemistry) Experience : 12 - 15 yrs in Biochemistry Reagents & Assay development and automated instrument handling. OR Qualification : PhD (Biochemistry) / MD (Biochemistry) Experience : 8 - 10 yrs in leading Clinical Biochemistry section in a Pathology Laboratory Show more Show less
Posted 1 month ago
15.0 - 17.0 years
0 Lacs
Bharuch, Gujarat, India
On-site
Job Description Jubilant Bhartia Group Jubilant Bhartia Group is a global conglomerate founded by Mr. Shyam S Bhartia and Mr. Hari S Bhartia with strong presence in diverse sectors like Pharmaceuticals, Contract Research and Development Services, Proprietary Novel Drugs, Life Science Ingredients, Agri Products, Performance Polymers, Food Service (QSR), Food, Auto, Consulting in Aerospace and Oilfield Services. Jubilant Bhartia Group has four flagships Companies- Jubilant Pharmova Limited, Jubilant Ingrevia Limited, Jubilant FoodWorks Limited and Jubilant Industries Limited. Currently the group has a global workforce of around 43,000 employees. About Jubilant Ingrevia Limited JubilantIngreviaisnowamemberoftheeliteGlobalLighthouseNetwork(GLN) oftheWorldEconomicForum(WEF) Celebrating our Culture and People. We are proud to be aGreat Place to Work certified! Jubilant Ingrevia history goes back to 1978 with the incorporation of VAM Organics Limited, which later became Jubilant Organosys and then Jubilant Life Sciences and now demerged to an independent entity as Jubilant Ingrevia Limited, which is listed in both the stock exchanges of India. Over the years, company has developed global capacities and leadership in chosen business segments. Ingrevia is born out of a union of Ingredients and Life (Vie in French). Jubilant Ingrevia Limited is committed to offering high-quality and innovative life science ingredients to enrich all forms of life. Jubilant Ingrevia, a global integrated Life Science products and Innovative Solutions provider serving, Pharmaceutical, Nutrition, Agrochemical, Consumer and Industrial customers with our customised products and solutions that are innovative, cost-effective and conforming to excellent quality standards. Jubilant Ingrevia Limited offers a broad portfolio of high-quality ingredients that find application in a wide range of industries. Jubilant Ingrevias portfolio also extends to custom development and manufacturing for pharmaceutical and agrochemical customers on an exclusive basis. Ourbusinessissplitacross3businessverticals,withgloballeadership acrossourkeyproductlines. Speciality Chemicals: The Specialty Chemical business of Jubilant Ingrevia manufactures Pyridine, Picolines and its forward integration derivatives, which finds application in agrochemicals, pharmaceuticals, dyes, solvents, metal finishes, fine chemicals, semiconductors etc. We have also launched new platform of Diketene & its value-added derivatives for multiple industry use. We are an established partner of choice in CDMO, with more investment plans in GMP & Non-GMP multi-product facilities for Pharma, Agro and Semi-conductor customers. Chemical Intermediates: The Chemical Intermediates business has acetic anhydride and value added anhydrides and aldehydes catering to various industries. Nutrition & Health Solutions: The Nutrition & Heath Solutions business unit offers B3 & Picolinates (Chromium & Zinc) which are fully backward integrated. Our ingredients find application in animal nutrition, human nutrition, personal care, etc. We provide high-quality feed & food additives having application in poultry, dairy, aqua & pet food industry. In Human Nutrition & Health Solutions, we offer food ingredients & premix solutions to nutrition. Jubilant Ingrevia Limited is supported by five state-of-the-art manufacturing facilities in India. We practice world-class manufacturing processes in our day-to-day operations, assuring our customers with unmatched quality and timely delivery of products through innovations and cutting-edge technology. Transforming Manufacturing for Operational Excellence & Sustainability with zero tolerance to any non-compliance is the core focus of Jubilant Ingrevia Manufacturing. We have 5 world-class manufacturing facilities i.e. One in UP at Gajraula, Two in Gujarat at Bharuch and Savli, Two in Maharashtra at Nira and Ambernath. Environment Sustainability The company is committed to environmental sustainability and supports green chemistry by prioritising the use of bio inputs in manufacturing. Jubilant is one of the worlds largest producers of Acetaldehyde from the bio route. Find out more about us at www.jubilantingrevia.com The Position: Organization: - Jubilant Ingrevia Limited Designation & Level: - AssociateDirector- Technology Transfer Location: - Bharuch Reporting Manager: - Head- Technology Cell The Structure: Head- Technology Cell Director- Technology Transfer Team Member 1 Team Member 3 Team Member 2 Team Member 4 Job Summary: As the Lead for Technology Transfer at the Bharuch site, you will lead and mentor a team of Process Engineers, ensuring smooth commercialization of new molecules. Your role includes coordinating with site functions, integrating new processes from R&D, and ensuring industrial-scale feasibility. You will guide hazard identification, safeguard activities, and oversee engineering studies and pilot scale implementations. Your expertise in tech transfer, process safety, and equipment design will support the team from concept to commissioning. Job Responsibilities: Process Integration - Oversee the integration of new molecule processes from R&D, ensuring critical lab demos are observed. Process Deviations - Direct the team in suggesting and testing process deviations at plant and R&D scales. Feasibility Assessment - Ensure the team assesses process feasibility on an industrial scale. Hazard Identification - Lead the team in hazard identification and safeguard activities. Engineering Studies - Supervise engineering lab studies to generate scale-up data. Performance Definition - Guide the team in defining lab-scale process performance and calculating variable costs. Pilot Studies - Oversee pilot scale studies to achieve desired performance. Conceptual Design - Review and implement conceptual designs at the plant scale with the team. Team Alignment - Align site teams (Operations, Engineering, QHSE) on design with team leadership. Engineering Modifications - Review proposed engineering modifications for plant implementation with the team. PHA Participation - Participate in PHA studies for high-hazard stages as a process expert. Engineering Support - Provide process engineering support from concept to commissioning with team involvement. RFQ Support - Review new molecule mapping for RFQ support with the team. Commissioning Activities - Lead process commissioning activities with cross-functional teams. Coordination - Coordinate with site functions to ensure smooth commercialization of new molecules. Guidance- Guide the team in managing multiple product commercialization with effective decision-making. Team Development and Support - Mentor process engineers, ensuring their continuous development and effective handling of activities The Person: Educational Qualifications & Work Experience: BE/B. Tech. in Chemical Engineering with 15+ years of experience in Process Engineering of specialty chemicals, agrochemicals fields. Technical Transfer and Safety Expertise In-depth knowledge of tech transfer and process safety, with the ability to implement these aspects during the conceptual design stage. Process Equipment Design Strong understanding of process equipment design and troubleshooting Team Management Must be capable of leading a team of Process Engineers Jubilant is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to age, ancestry, citizenship, colour, gender identity or expression, genetic information, marital status, medical condition, national origin, political affiliation, race, ethnicity, religion or any other characteristic protected by applicable local laws, regulations and ordinances. To know more about us, please visit our LinkedIn page: https://www.linkedin.com/company/jubilant-bhartia-group/ Show more Show less
Posted 1 month ago
15.0 - 20.0 years
0 Lacs
maharashtra
On-site
The AGM / DGM Technical Services position requires a candidate with a B.Pharma / M.Pharma qualification and 15 to 20 years of experience in tech transfer activities of solid oral dosage forms for regulated markets. The ideal candidate should have experience in managing a team of 15 to 20 scientists, documentation officers, and technicians. As an AGM / DGM Technical Services in Kandivali, Mumbai, your responsibilities will include planning and executing scale-up and Exhibit batches of solid oral dosage forms for regulated markets such as US, EU, ROW, and Canada. You will be accountable for ensuring the timely initiation of stability studies for exhibit batches and overseeing the technical service area, specifically the Pilot batch area. Your role will involve reviewing all relevant documents for scale-up and Exhibit batches execution, such as BMR, BPR, Protocols, scale-up report, exhibit batches report, and providing filing documents to RA. You will collaborate with cross-functional teams including site manufacturing team (Production, QA, QC), R&D, RA, PDC, and Supply Chain to meet aggressive timelines for regulatory submissions and business priorities. In addition, you will be responsible for reviewing, approving, and effectively implementing change control proposals, deviations/incidents, and CAPA for scale-up and exhibit batches. Addressing deficiencies identified by regulatory agencies related to drug products and supporting the production department for validation batches and troubleshooting of commercial batches will also be part of your duties. It is essential to perform all job responsibilities in compliance with cGMP, SOPs, and other regulatory agency requirements to ensure quality and regulatory standards are met.,
Posted 1 month ago
3.0 - 7.0 years
0 Lacs
karnataka
On-site
As a consultant within Life Science, you will have the opportunity to make a real difference by contributing to the improvement of people's lives and quality of life through the development of production, quality, and project activities. The role primarily focuses on validation and is suitable for those who want to ensure that all products, systems, and services released to the market are safe and accessible to everyone. Your development is our priority, and we are committed to supporting your growth in the direction you desire. In addition to valuable work-related exchanges through networks and activities, you will be surrounded by colleagues who are genuinely interested in you as a person. Joining our Compliance & Management business area, you will play a key role in facilitating an effective transition to digital, sustainable, and secure solutions through expertise in quality, security, sustainability, and project management. **Responsibilities:** Your tasks will vary, providing you with the opportunity to work on validation of processes, equipment, methods, or computerized systems. Assignments may also involve validation leadership or validation strategies. Your responsibilities include, but are not limited to: - Equipment and system validation - Ensuring project timelines are met - Coordinating between different project functions - Driving solutions to challenges that arise - Leading, coordinating, and conducting risk analyses - Leading deviation investigations - Tech Transfer **Qualifications:** To excel in this role, you should have an interest in technology, enjoy working in complex production environments, and thrive in a diverse consultant role. Problem-solving abilities, adaptability, and effective communication skills are essential. We also expect you to have: - Experience in the pharmaceutical industry - Experience in validation/qualification (of equipment/system) - Previous experience in roles such as validation engineer, project engineer, quality engineer, or similar - Proficiency in both spoken and written Swedish and English **About Knightec Group:** Semcon and Knightec have merged to form Knightec Group, the leading strategic partner in product and digital service development in Northern Europe. With a unique blend of cross-functional expertise and a holistic understanding of business, we help our clients realize their strategies from concept to completion. At Knightec Group, we have the expertise, attitude, and drive needed to take on the most challenging and innovative projects. For our employees, this presents incredible opportunities to shape the future through meaningful projects at the forefront of technology. Here, you will not only grow and develop but also become part of something greater. If this sounds like the place for you, join us on an exciting journey! **Practical Information:** Submit your application as soon as possible, but no later than 30th August 2025. For any questions regarding the position, feel free to contact Talent Acquisition Partner Lina Jderborn. Please note that, due to GDPR, we only accept applications through our career page. We look forward to hearing from you!,
Posted 1 month ago
5.0 - 7.0 years
5 - 8 Lacs
Ahmedabad
Work from Office
Conduct NPD, process optimization, scale-up & value engineering. Develop synthetic routes, validate methods, identify raw material alternatives. Maintain documentation. Support validation & transfers. Coordinate with QA, QC & production.
Posted 1 month ago
2.0 - 4.0 years
2 - 6 Lacs
Bengaluru
Work from Office
Role & responsibilities Responsible for execution of Cost improvement projects (CIP) for the existing processes and products . To prepare the basic and detailed engineering for CAPEX projects. Preparation of qualification documents for CAPEX projects. Responsible for execution of Operational excellence (OE) activities at site. Trouble shooting of plant problems and de-bottle necking of processes. Support the respective department personnel during execution of new initiatives/modifications/ improvements in existing processes. Conducting HAZOP for any product/process/plant and preparation of HAZOP report. Preferred candidate profile B.Tech in Chemical Engineering with 2 to 4 years of work experience in Technical Service department (API Industry only) . Please share CVs to ramya_n@hikal.com with subject line as Application for Technical Service department .
Posted 1 month ago
6.0 - 11.0 years
6 - 12 Lacs
Baddi
Work from Office
Role & responsibilities Manage technology transfer activities from development to commercial manufacturing for OSD tablets. Oversee and execute process scale-up, process optimization, and validation to ensure smooth transition into commercial production. Maintain an in-depth knowledge of USFDA regulations for OSD products and ensure compliance with all regulatory requirements during tech transfer activities. Work closely with R&D, manufacturing, and quality teams to address any technical challenges during tech transfer. Preferred candidate profile Prefered candidates from OSD (manufacture Tablets , capsules,)background . USFDA experince is must Its a plant based role.
Posted 1 month ago
3.0 - 6.0 years
2 - 7 Lacs
Dombivli
Work from Office
Role & responsibilities 1. Pilot Plant Operations Management: Supervise and lead a team of technicians and operators to ensure efficient and safe operation of the pilot plant. Develop and implement standard operating procedures (SOPs) for various pilot plant processes and activities. Coordinate with cross-functional teams, including research and development, engineering, and analytical to ensure seamless integration and execution of pilot plant activities. Monitor and maintain equipment and instrumentation, ensuring their proper calibration and functionality. Troubleshoot and resolve operational issues to minimize downtime and optimize productivity. Ensure compliance with safety protocols, environmental regulations, and good manufacturing practices (GMP) during pilot plant operations. 2. Process Development and Optimization: Collaborate with R&D teams to design, develop, and scale-up new processes and technologies for pilot-scale production. Conduct experiments and trials to optimize process parameters, yields, and efficiencies. Analyze and interpret data generated from pilot plant experiments, identifying trends and recommending improvements. Work closely with engineers to evaluate and select appropriate equipment and technologies for pilot plant operations. Document and maintain comprehensive records of pilot plant activities, including process parameters, batch records, and deviations. 3. Project Management: Plan and execute pilot-scale production campaigns in accordance with project timelines and objectives. Coordinate with internal stakeholders to ensure timely availability of resources, materials, and utilities required for pilot plant operations. Monitor project progress and provide regular updates to management, highlighting any potential risks or deviations from planned schedules Collaborate with external vendors and contractors, as necessary, to procure equipment, supplies, and services for the pilot plant. 4. Training and Compliance: Train and mentor pilot plant staff on standard operating procedures, safety protocols, and quality standards. Ensure compliance with regulatory requirements, quality management systems, and company policies. Participate in audits and inspections, addressing any findings and implementing corrective actions. Stay updated with industry trends, technological advancements, and best practices related to pilot plant operations Preferred candidate profile Should possesses strong knowledge of chemical processes, unit operations, and equipment commonly used in pilot-scale manufacturing Familiar with process optimization techniques, statistical analysis, and experimental design Excellent leadership and team management skills, with the ability to motivate and inspire a diverse group of individuals Strong project management abilities, including the capability to prioritize tasks, manage resources, and meet deadlines Effective communication skills, both verbal and written, with the ability to interact with cross-functional teams, senior management, and external stakeholders Attention to detail, analytical thinking, and problem-solving skills Takes personal responsibility to make things happen and continuously raise the bar. Displays a high degree of emotional maturity and awareness of own impact. Defines and leads change initiatives for own work area Continuously raises the teams performance to best in class levels and creates a culture of high accountability
Posted 1 month ago
5.0 - 10.0 years
5 - 15 Lacs
Mysuru
Work from Office
Role & responsibilities Review of Technology data package and preparation of Gap analysis document. Preparation of technology transfer protocol and report. Co-ordination with FD for smooth Tech Transfer. Monitoring of validation batches at production site. Perform Feasibility trials, Product evaluation trials to understand critical process parameter for smooth transfer and process understanding. Review of MPCR and protocol. Planning for Execution of Process design, Process qualification batch. Coordination with Production, Quality assurance, Quality control, Engineering, Regulatory Affairs, SCM and warehouse for the TT activities. Should be part of handling deviation, change control and failure investigations. Process manufacturing parameters for Qualification batches Vs Commercial batches. Preparation and reviewing of intended batch documents for regulatory submission. Trouble shooting of existing products and process improvement to increase output or to reduce processing time or to improve the quality of products. Preferred candidate profile required from OSD pharmaceutical Executive - TT: Exp required: 04 to 06 years Dy. Manager: Exp required: 09 to 12 Years Candidate should be willing to relocate/work in Nanjangud, Mysuru Plant.
Posted 1 month ago
8.0 - 13.0 years
5 - 10 Lacs
Pune
Work from Office
Role & responsibilities Asst Manager / Sr. Executive - Regulatory DRA DEPT- Europe Market @ Pharma Formulation -PUNE City. Person will be responsible for DRA function for Pharma Formulation for Advanced Markets / EU The candidate should be conversant with preparing dossiers for Finished Formulations for EU. Preferred candidate profile Honest, Hard Working. Growth Mindset (Important). Good Communications Skills. Relevant Experience in Pharma Only Candidate with Relevant Experience may apply. We also encourage rightful candidates to write directly to us to "info@vekocare.com" with a proper covering note.
Posted 1 month ago
5.0 - 10.0 years
14 - 15 Lacs
Mumbai, Mumbai (All Areas)
Work from Office
Job Title: Dy Manager R&D-Technology Transfer Location : Mumbai Location Industry: Pharma Industry Experience: Minimum 5.to 10 years . Able to scale up technology from R&D to Kilo scale/ pilot scale/ commercial scale Coordination with R&D team for generating negative study data, concluding to optimize process parameters interested candidates can share cv to hr3@sarthee.com or call at 9033033650
Posted 1 month ago
2.0 - 6.0 years
5 - 9 Lacs
Mumbai Suburban
Work from Office
Responsible for scale up technology from R&D to Kilo scale/ pilot scale/ commercial scale Coordination with R&D team for generating negative study data, concluding to optimize process parameters Observe R&D demo batches & preparation of demo batches report Identify & propose ideas to improve process efficiency, effective utilization for unit process & operations Preparation of BFD, PFD, P&ID, mass balance, energy balance sheets Monitor process optimization & validation batches at pilot/ commercial scale at different manufacturing sites Support the external job work activity to achieve desired yield and quality Coordination with cross functional teams to implement process through scale-up & capacity enhancement Preparation of optimization & validation campaign reports after completion of projects
Posted 1 month ago
5.0 - 7.0 years
5 - 8 Lacs
Jammu
Work from Office
Role & responsibilities To perform the Technology transfer of Product from R&D to Site receiving activities and QMS related activities at the manufacturing plant . To perform alternate vendor batch execution, process improvement, change in batch size, trouble shooting at shop floor, equipment change activities of product after technology transfer completion along with production team. To finalize batch sizes of scale up, exhibit and commercial batches to meet the equipment capacities and regulatory requirements with consent of R&D and production. To prepare/review relevant documents like SOP, Batch Manufacturing Record, Sampling Protocol, hold time study protocol/ report, stability study protocol/report, Process validation protocol and Report for the scale up, exhibit and validation batches. To provide technical support for change management, investigations of deviations or OOS, CAPA identification and QMS related activities at plant. Ensure cGMP and Regulatory compliance.
Posted 1 month ago
10.0 - 14.0 years
0 Lacs
haryana
On-site
As a Technical and Scientific Leader in upstream processes for early-stage development, you will play a crucial role in ensuring the seamless handover of Suns Branded Portfolio products from development to commercialization. Your responsibilities will include providing quality input into CMC strategy, representing quality oversight in various stages of process development, and contributing to the planning of Clinical trial materials. You will also collaborate with cross-functional teams to facilitate a smooth transition to Commercial QA and manufacturing. Your scientific leadership will be instrumental in supporting process and product investigations, troubleshooting issues, and identifying opportunities for improvement. You will be expected to leverage your technical expertise to oversee experimental planning, analyze development results, and review manufacturing data. Additionally, you will be responsible for authoring and reviewing CMC documentation for regulatory filings, as well as providing support during health agency inspections. In order to excel in this role, you must possess an MS or PhD in chemical/biochemical engineering, biochemistry, or a related field, along with a minimum of 10 years of relevant experience. A proven track record of technical manufacturing experience, the ability to drive technical quality rigor, and strategic analysis skills are essential. Your capacity to manage multiple projects in a fast-paced environment, utilize risk-based decision-making approaches, and work collaboratively in a matrix environment will be critical to your success. Furthermore, your strong interpersonal skills, effective communication abilities, and demonstrated project management capabilities will be valuable assets in this role. Experience with audits in global regions and the flexibility to travel to the US and/or EU countries will be advantageous. If you are looking to join a dynamic Development Quality team and contribute to the advancement of Suns Branded Portfolio products, this opportunity may be the perfect fit for you.,
Posted 1 month ago
8.0 - 13.0 years
10 - 20 Lacs
Ahmedabad
Work from Office
Summary Job Functions: Handling, supporting and executing all activities including training to subordinates for manufacturing process support and any late stage developmental work for process improvement related to Downstream process in MSAT. Key Responsibilities: - Execution of process scale up experiments, documentation and process improvements to support manufacturing. - Process transfer and execution of tech. transfer with help of BBM. - Planning and executing experiments of DSP for process improvement, demonstrating and recording the same in proper format / report. - Designing and execution of scale down experiments to support manufacturing for scale up. (Bag evaluation/Filter sizing/Alternate vendor evaluation etc.) - Drafting the process related reports, protocols and IOC as a part of documentation - Support of process transfers- Evaluation and support for implementation of new processes focusing on direct transfers - Preparation of Qualification /verification documents (Protocols and reports) of equipment Responsible for conducting experiments to support the manufacturing team in need for any issues or improvement in the process. Both for microbial and mammalian process - Responsible for providing shop floor support during scale up activities for engineering, CT and PPQ batches - Ensures corporate cGMP and GLP compliance of all activities performed. - To follow Good Documentation Practices and Data Integrity’ requirements during any GxP Operation and recording at site. - To take responsibility that application of Data Integrity requirements and potential consequences for not following it are understood and followed. - To review in the perspective of compliance to Data Integrity requirements while reviewing any GxP data (Records, Reports) specific to Job description.
Posted 2 months ago
5.0 - 10.0 years
5 - 11 Lacs
Udaipur
Work from Office
Preferred candidate profile Relevant experience in scale-up of processes from laboratory scale to pilot to plant scale, technology absorption from laboratory, preparation of BFD / PFD, mass balance, utility calculations E-mail - Deepanshu.bhatt1@piind.com Mobile - 8696900583
Posted 2 months ago
3.0 - 8.0 years
0 - 1 Lacs
Manesar
Work from Office
Technology transfer of new molecules from R&D to plants (in-house as well as outsourced locations) through Kilo lab and Pilot plant. Day-to-day operation management of tech-transfer activities. Review of basic engineering design package for Technology transfer. Review of critical and hazardous activities planned in tech-transfer campaign. Close batch monitoring wherever critical operations are involved. Plant troubleshooting, capacity enhancement and provide technical support in repeat campaigns. New products Production planning, monitoring and delivering on time. Provide training to team members. Ensuring personal safety in place. Ensuring GMP compliance in day-to-day work
Posted 2 months ago
10.0 - 14.0 years
0 Lacs
maharashtra
On-site
Job Title: AGM R&D Cosmetics Location: Mumbai Job Type: Full Time Job Requirements: Key Internal Interactions R&D / QC: Inputs to process selection & optimization. Planning for infrastructure & process development work in the pilot plant and analytical requirements. Sales & Marketing: Gather market information on new products/idea, screening of ideas, and Guidance on new product development in the pilot plant including product costing, job worker evaluation, process evaluation etc. Pilot plant: Overseeing of pilot plant operations; Planning, review & monitoring of product trials, Guidance, direction & inputs to pilot plant in charge. Manufacturing: Oversee planning & coordination for in-house plant trials, scale up of new products, Raw materials booking for job work process trials, performance analysis & review of in-house trials, for process improvement projects Purchase: Oversee Planning & Coordination for procurement of Raw materials/Equipments etc for process development work in pilot plant / Job work, for procurement of equipment for commercial plant, for techno-commercial evaluation & discussions with suppliers. Projects: Coordination for detail engineering package development, techno-commercial discussions with suppliers, CAPEX estimation & schedule workout for the project and project coordination. Key External Interactions Research Organizations/Educational Institutes: Liasoning for strengthening capabilities and projects Industry Forums: Interact and represent company in Industry forums, govt liasioning for R&D work Customer R&D and manufacturing heads: Understanding customer research and product improvement needs; analyze customer products and suggesting new/ improved products/ processes as per customer requirements Key Responsibilities:1. Planning and Strategizing Ensure that R&D Cosmetics projects are completed on time and within budget Formulate and execute the Research & Development strategy for the organization by understanding business needs and industry developments Plan and develop a product development strategy Develop new raw material vendors, Alternate vendors Oversee SAP BOM of Cosmetics for correctness 2. Policy and Process Design, Implementation and Review Documentation for FDA and Tech transfer Troubleshooting the operational and quality issues at mfg plants across the globe Suggest new process, improve existing process at plant to improve the quality of Cosmetics and productivity at Plant. Support implementation and design of processes to foster a continuous improvement environment Develop and govern process of generating new product basket, funneling, stage gate process, lab/pilot trials and commercialisation Oversee the design and implementation of all R&D &CI processes and policies -Cosmetics Champion new product development through sanctioning and approving proposals, obtaining patents and copyrights and reviewing product development team performance to ensure that customer expectations are met Review progress on continuous improvement projects and initiatives, such as suggestion schemes, continuous improvement teams, quality circles etc Review and approve product formulation as well as the change of production processes Review progress of R&D and CI projects -Cosmetics Interface with BU Heads, Function Heads, R&D business partners and customers/ clients to identify opportunities for product development Guide QC/QMS teams for system compliance to Cosmetics industry standards 3. Coordination, Interface, Imparting Training Technical support to Exim dept for correctness of HSN codes for Cosmetics category Technology transfer of New Cosmetics , syndets , Noodles at plant Participate in the routine oil purchase meetings and suggest oil combinations for cost-effective noodle preparations Provide scientific guidance and advice to the Cosmetics leadership team to enable them to decide on priorities and make cost-effective decisions Develop and maintain contacts with relevant organizations in the industry for exchange of ideas and information Interface with BU Heads, R&D business partners and customers/ clients to identify opportunities for product development Liasoning with Senior management for approvals/appraisals of the reporting team Participate in seminars and industry conferences to keep abreast with the latest development in the industry Influencing internal stakeholders to achieve targets on time Facilitating meetings with external suppliers for obtaining techno-commercial offers, workers for production trials etc. Review of SOPs for new product processing & facilitate training and skill development of team Customer approval for new products Coordination with the Supply chain for Expired raw materials management of Cosmeticss 4. Management of performance, capability and morale Suggest and initiate Cost saving projects in Cosmeticss Manage performance of the Cosmetics R&D team, support capability building and ensure that individual/ team morale and motivation is positive Mid-year and final appraisals completed on time for direct reports. 5. Infrastructure and Technology Investment and Management Develop and implement new processes and technology in Cosmeticss to improve business performance.Suggest new hardware and improve existing hardware of Cosmetics mfg at plants as and when reqired Development of Cosmeticss , syndet, noodles formulations for Global business requirement Ensure that new products in Cosmetics category are developed to improve business performance (New products includes variants of existing products) Encourage and sanction the use of up to date equipment and support team in learning about new technology Key Result Areas (KRAs)1. Technology Development Technology refinement for translucent noodles (min benchmark Jocil quality) Syndet Cosmetics throughput to be increased by dedicating line with support from cross cross-functional team 2. International Sites Technical support to International sites Technical support by demonstrating at the main plant at USA, Dubai, Poland & South Africa apart from India 3. Method Development Method development for active analysis at the factory instead of sending to 3P Lab Baddi First time right in commercial trials with quality documentation 4. OTIF Delivery OTIF delivery of NPD for both when we are developing formulations / supporting rollouts for CMB (timeliness of delivery & quality of roll out) Softsens products-Develop on the innovation requirements for Softens 5. People Development Improve service standard to internal stakeholders. Functional skill development Cross-functional training of R&D team in Cosmetics and Liquid technology., Analysis of products. Timesheet generation and monitoring Technical Skills & Knowledge Thorough understanding of the R&D environment, industry best practice and trends Thorough knowledge of compounds, processes, products, packaging etc relevant to the business Thorough understanding of manufacturing processes and standards Knowledge of the companys strategy, structure and practices Strong project management skills Job Types: Full-time, Permanent Schedule: Day shift Experience: total work: 10 years (Required) Cosmetics: 10 years (Required) Work Location: In person,
Posted 2 months ago
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