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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 7 hours ago
9.0 - 12.0 years
8 - 11 Lacs
chennai
Work from Office
Responsible to ensure Technology Transfer activities (From R&D to site, From Site to site). Manage the Scale-up, Process Optimization, submission batches, Process Validation, Process Improvements & Troubleshooting activities. Ensure timely execution of Feasibility, Assessment, Registration, New product launches and AVD projects by continuous co- ordination with unit Production, QC, ADL, RA and Project Management Team. Monitoring the progress of product status during stability study, responding the queries from various regulatory bodies. Review of Process Optimization reports. Review of gap analysis and define the action plan. To provide technical inputs for closure of OOS/OOT. Identification of Critical Process Parameters (CPPs), Scale Dependent (SD) and Scale Independent (SI) parameters and Control strategy for process Validation. Review of QbD elements (QTPP, CQA, CMA, CPP's, FMEA, DoE and Control Strategy).
Posted 4 days ago
10.0 - 15.0 years
14 - 17 Lacs
chennai
Work from Office
Greetings!!!! We are looking for a QA - Manger - OSD _Chennai Location Job Description: Responsible for BMR, batch release, validations, qualifications, SOPs, GMP compliance. Handle audits, QMS (Deviation, OOS, OOT, CAPA), and technology transfer. Exposure to analytical operations will be an added advantage. Strong experience in OSD / Liquid formulation QA required. Key Skills: QA, Quality Assurance, BMR, Batch Release, Validation, GMP, SOP, QMS, Audit, Deviation, OOS, OOT, CAPA, Pharma QA. Salary: As per market standards Note: Immediate joiners preferred. Interested Candidates Kindly share your updated cv to uma@bvrpc.com
Posted 5 days ago
6.0 - 8.0 years
0 Lacs
noida, uttar pradesh, india
Remote
ZS is a place where passion changes lives. As a management consulting and technology firm focused on improving life and how we live it, we transform ideas into impact by bringing together data, science, technology and human ingenuity to deliver better outcomes for all. Here you'll work side-by-side with a powerful collective of thinkers and experts shaping life-changing solutions for patients, caregivers and consumers, worldwide. ZSers drive impact by bringing a client-first mentality to each and every engagement. We partner collaboratively with our clients to develop custom solutions and technology products that create value and deliver company results across critical areas of their business. Bring your curiosity for learning, bold ideas, courage and passion to drive life-changing impact to ZS. Insights & Analytics ZS's Insights & Analytics group partners with clients to design and deliver solutions to help them tackle a broad range of business challenges. Our teams work on multiple projects simultaneously, leveraging advanced data analytics and problem-solving techniques. Our recommendations and solutions are based on rigorous research and analysis underpinned by deep expertise and thought leadership. Supply Chain - Chemistry Manufacturing & Controls ZS is looking to hire a Decision Analytics Consultant in ZS Supply Chain and Manufacturing practice with experience in pharmaceutical drug development and tech transfer. The primary responsibility of this role is to deliver projects in the pharmaceutical CMC development area for ZS clients. This includes serving as a subject matter expert on drug substance and drug product manufacturing in client discussions, managing teams and projects, and contributing to Supply Chain and Manufacturing practice development. What You'll Do Leverage quantitative skills to derive answers to clients ongoing business analytics and reporting questions Work collaboratively with client to ascertain the client's specific business information needs Upskill on concepts relevant to solve client problems across modalities Discuss and determine with clients which specific data may be best utilized in order to perform the necessary analysis Evaluate, assess and analyze the data necessary to provide solutions to the clients particular business information needs Communicate the data results to the client, with an emphasis on answering the business question as opposed to the analytical and reporting processes used Gain immediate familiarity with client's internal processes Develop expertise within a client analytics area Be available for clients during regular working hours What You'll Bring Bachelor's (and often graduate) degree in Chemical Engineering, Mechanical Engineering, Chemistry, Biotechnology or similar degree 6-8 years of experience working in a pharmaceutical CMC organization Hands-on experience with at least one of the functions in CMC development such as Process Chemistry, Process Engineering, Formulation, and Analytical Chemistry Knowledge of key concepts including unit operations, processes, quality by design (QbD), tech transfer, process validation, quality attributes, and regulatory milestones across pharma development Understanding of the different data and information systems such as ELN, LIMS, ERP systems, and LCM or PLM systems Understanding of the CMC related regulatory submission requirements Ability to translate the knowledge of concept in one modality to other modalities, if needed Experience presenting to senior leaders, executives, and audiences with CMC backgrounds Hands-on experience with data analytics with ability to generate insights from data from various sources Ability to lead multiple workstreams and demonstrate effective time and project management skills Experience with at least one tech transfer, exposure to analytics, AI and/or technology implementation in CMC preferred Perks & Benefits: ZS offers a comprehensive total rewards package including health and well-being, financial planning, annual leave, personal growth and professional development. Our robust skills development programs, multiple career progression options and internal mobility paths and collaborative culture empowers you to thrive as an individual and global team member. We are committed to giving our employees a flexible and connected way of working. A flexible and connected ZS allows us to combine work from home and on-site presence at clients/ZS offices for the majority of our week. The magic of ZS culture and innovation thrives in both planned and spontaneous face-to-face connections. Travel: Travel is a requirement at ZS for client facing ZSers business needs of your project and client are the priority. While some projects may be local, all client-facing ZSers should be prepared to travel as needed. Travel provides opportunities to strengthen client relationships, gain diverse experiences, and enhance professional growth by working in different environments and cultures. Considering applying At ZS, we honor the visible and invisible elements of our identities, personal experiences, and belief systems-the ones that comprise us as individuals, shape who we are, and make us unique. We believe your personal interests, identities, and desire to learn are integral to your success here. We are committed to building a team that reflects a broad variety of backgrounds, perspectives, and experiences. about our inclusion and belonging efforts and the networks ZS supports to assist our ZSers in cultivating community spaces and obtaining the resources they need to thrive. If you're eager to grow, contribute, and bring your unique self to our work, we encourage you to apply. ZS is an equal opportunity employer and is committed to providing equal employment and advancement opportunities without regard to any class protected by applicable law. To complete your application: Candidates must possess or be able to obtain work authorization for their intended country of employment.An on-line application, including a full set of transcripts (official or unofficial), is required to be considered. NO AGENCY CALLS, PLEASE. Find Out More At:
Posted 5 days ago
5.0 - 9.0 years
0 Lacs
pune, maharashtra
On-site
As a Group Leader in the HP API Lab, you will be responsible for leading the end-to-end synthesis and scale-up of HP APIs. A Ph.D. in organic chemistry from reputable institutions in India or overseas, with post-doctoral experience being preferable, is required for this position. Your primary focus will be to ensure containment and EHS compliance throughout the process. In this role, you will drive cross-functional collaboration to facilitate successful technology transfer and scale-up processes. Your expertise and leadership will play a critical role in the advancement of the HP API Lab's objectives.,
Posted 5 days ago
6.0 - 10.0 years
6 - 12 Lacs
vapi
Work from Office
Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs
Posted 6 days ago
6.0 - 10.0 years
6 - 12 Lacs
valsad, pardi
Work from Office
Lead formulation R&D for OSD, external, and liquid preparations. Oversee pre-formulation, development, and scale-up, ensuring regulatory compliance. Manage tech transfer and mentor junior scientists. Required Candidate profile B.Pharm/ M.Pharm 6-10 Yrs
Posted 6 days ago
4.0 - 13.0 years
0 Lacs
hyderabad, telangana
On-site
The Manager of Competitive Intelligence R&D at Amgen will play a crucial role in leading intelligence gathering activities to support marketing teams across various business units. Reporting directly to the Director/Sr Director of Competitive Intelligence, you will work on-site at the Amgen India Hyderabad Office for a minimum of 4 days a week. Your primary responsibilities will include developing and presenting key Competitive Intelligence deliverables for internal stakeholders, leveraging various secondary research resources to generate competitive insights, working with R&D leads to conduct primary and secondary competitive intelligence research, and managing multiple CI vendors for hypothesis-driven primary CI research. You will also be expected to understand the US patent landscape for early drug development, synthesize insights from scientific and medical research conferences, and travel as needed. To excel in this role, you should possess a Doctorate, Masters, or Bachelors degree with relevant experience in Competitive Intelligence, Business Development, Tech Transfer, Equity Research, Consulting, or Patent Law. Strong communication skills, the ability to generate insights from complex scientific data, and experience with early pipeline development are highly preferred. Additionally, knowledge of pharmaceutical value chain principles, experience managing multiple projects, and the ability to analyze clinical trials and global regulatory considerations are key qualifications for this position. Amgen is dedicated to supporting your professional and personal growth by offering competitive benefits and fostering a collaborative culture that values your contributions. We are committed to providing equal opportunities for all individuals, including those with disabilities, and offer reasonable accommodations throughout the application and employment process. Join us in our mission to serve patients and make a meaningful impact on their lives and our business.,
Posted 6 days ago
7.0 - 11.0 years
0 Lacs
ahmedabad, gujarat
On-site
You will be responsible for the formulation development of Pharmaceutical and Nutraceutical products including tablets, capsules, effervescent tablets, sachets powders, and liquid formulations. This involves conducting literature search and patent search for the formulation, as well as developing cost-effective and fast production processes along with stable formulations. You will be required to create MFR and relevant specifications, facilitate tech transfer, and maintain documentation. Additionally, you will need to address any ongoing issues in the existing formulations. The ideal candidate should have 7 to 10 years of experience in this field. If you are interested in this opportunity, please reach out to hrd@stravahealthcare.com for further details.,
Posted 1 week ago
2.0 - 7.0 years
14 - 15 Lacs
mumbai, mumbai (all areas)
Work from Office
Job Title: Dy Manager Technology Transfer Location : Mumbai Location Industry: Pharma Industry Experience: Minimum 2 years . Division: API Key Role & Responsibilities: 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 Observe R&D demo batches & preparation of demo batches report Identify & propose ideas/ technology to improve process efficiency, effective utilization for unit process & operations Preparation of BFD, PFD, P&ID, mass balance, energy balance sheets Skills: Technology Transfer, Process, Scale-up, optimization, validation, PFD, P&ID, BFD, troubleshooting, Process improvement, Technical services, debottlenecking, yield improvement, Data interpretation Kilo lab, Piloting, Equipment selection, mass balance, HAZOP study, MS-Office interested candidates can share cv to hr3@sarthee.com or call at 9033033650
Posted 1 week ago
13.0 - 20.0 years
20 - 35 Lacs
pune
Work from Office
Hiring for Principal Scientist for a leading Pharma MNC at Pune. Role & responsibilities Reporting to : Associate Director Job Summary : To develop synthesis processes of highly potent and/or cytotoxic ADC drug-linkers and transfer processes to internal/external clients and collaborate with manufacturing teams to deliver robust chemical processes that are suitable for commercial-scale manufacturing, while ensuring safety and regulatory compliance. Key Responsibilities: 1. Detailed technical evaluation of project enquiries received from the customers/ BD team. 2. Literature search, scouting the appropriate routes, and Drug-linker process optimization. 3. Execution of Bioconjugation Chemistry in lab and GMP manufacturing on Lab scale. 4. Collaborating with synthetic/analytical chemists, bioconjugation scientists, biologics development team, engineers, PM, DQA, IPMG, BD, PE/TT, manufacturing units, and regulatory teams to develop and support the commercialization of ADCs. 5. Support for kilo lab batches and during commercial campaigns to achieve the QOTIF. 6. To help grow the ADC teams capabilities, research facilities, and enhance the ADC's portfolio. 7. Thorough drug-linker process development and support regulatory submissions, often with compressed timelines. 8. When appropriate, mentor, train, and supervise junior team members in this role. 9. Help drive internal facilities growth to support highly potent and/or cytotoxic material handling. 10. Manage multiple projects and/or material deliveries simultaneously. 11. Monitor and implement safety in the laboratory. 12. Troubleshoots technical challenges during scale-up & tech transfer, monitors schedules, and manages documentation in line with GMP guidelines. Preferred candidate profile Required Qualifications and Experience: MSc organic chemistry with 13+ years of relevant industrial experience in the process development/optimization of ADCs or PhD/post-doctorate in synthetic organic chemistry with experience in ADC drug-linkers. Key Competencies: Problem solving. Conflict resolution. Decision making. Communication skills. Leadership. Negotiation. Collaboration. Cross-functional collaboration. Technical Skills: Proficient in using MS Office. Knowledge of ADCs, Knowledge of High-potent API, Knowledge of working in GMP set-up, organic/process chemistry & safety API process development, tech transfer & manufacturing, proficient analytical skills for small as well as large molecules. to apply please share Resumes with Puja.k@maxisclinical.com Regards Puja
Posted 1 week ago
2.0 - 5.0 years
3 - 5 Lacs
ahmedabad
Work from Office
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.
Posted 1 week ago
8.0 - 12.0 years
8 - 14 Lacs
mysuru
Work from Office
Vibonum Technologies Pvt Ltd (Althera Groups) is hiring Assistant or Deputy Manager - Technology Transfer Executive for its OSD Pharma manufaturing plant at Nanjangud, Mysore. 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: 08 to 12 years with M. Pharm Candidate should be willing to relocate/work in Nanjangud, Mysuru Plant. Benefits: Free canteen facility Free transport facility Medical Insurance All Statutory benefits etc.
Posted 1 week ago
8.0 - 12.0 years
12 - 18 Lacs
shamirpet, hyderabad
Work from Office
JD for External Manufacturing - Process Engineering Role & responsibilities: Identify 3rd parties for execution of Scaleup and manufacturing projects Identify 3rd parties with different capabilities Facility visit and Preliminary facility assessment report covering all the capabilities To co- ordinate with safety and quality team for audit and approval To co -ordinate between 3rd party and internal legal team to finalize CDA SWOT analysis of 3rd party Statutory and Legal compliance of 3rd party - confirmation from SCM to be co ordinated Collection of last 3 years audited finance report and to share with finance team to understand the financial stability of the organization To Co-ordinate with project team to finalize the 3rd party and modification requirement To Co-ordinate with SCM, Ware House, PPIC, finance for Job work permit and material movement Continues monitoring of projects while execution To Co -ordinate with execution team and 3rd party to validate the consumption co efficient, reactor/equipment occupancy and Spent solvent Preferred candidate profile Qualification : B.tech/M.Tech in Chemical Engineering Experience : PE/TAT + handling external manufacturing with 8-12 years experience
Posted 1 week ago
10.0 - 14.0 years
0 Lacs
maharashtra
On-site
The Bland Company is a food and biotech startup dedicated to producing cost-efficient, highly functional ingredients through innovative biochemical processes. Our clean-label proteins are designed to assist food brands in reducing their reliance on egg-derived ingredients without sacrificing functionality. Currently engaged in trials with major CPGs and supported by top-tier investors and industry advisors, our founding team comprises biochemists and biochemical engineers committed to revolutionizing the food industry. As the Head of R&D, you will play a pivotal role in spearheading scientific innovation and overseeing manufacturing scalability. Your responsibilities will include leading a team of scientists and application experts focusing on protein chemistry, scale-up, and formulation science. This unique opportunity allows you to shape the technical direction of a company at the forefront of sustainable food production. Key Responsibilities: - Lead R&D efforts in protein chemistry, process optimization, and application science - Align technical objectives with business goals and ensure timely delivery - Develop and execute the R&D roadmap, from refining the platform to validating client applications - Identify and assess new scientific methods and technologies to expedite progress - Recruit, manage, and mentor a diverse team of specialists - Supervise experimental design, data analysis, and documentation - Collaborate with the founding team on IP strategy, regulatory planning, and scientific communication - Assist in scaling up R&D processes for manufacturing - Coordinate with external partners such as labs, CROs, academic collaborators, and suppliers - Contribute to strategic decisions on prioritizing food categories based on ingredient performance and customer feedback - Manage the establishment and operation of a state-of-the-art laboratory Requirements: - PhD in Biochemistry, Chemistry, Food Science, Biotechnology, or a related field - Over 10 years of industry experience in food ingredient or protein R&D, with a proven track record of leading projects and teams - Profound knowledge of plant protein structure, functionality, and structure-function relationships - Expertise in various protein modification methods, including physical, chemical, and biological approaches - Hands-on experience in protein purification and characterization techniques - Familiarity with food product development cycles and application testing - Strong project management, communication, and mentoring skills - Exposure to ingredient scale-up and technology transfer from lab to commercial scale - Bonus points for experience with upcycled ingredients and regulatory strategies What You'll Get: - A leadership role within a high-impact food biotech startup - Opportunity to lead a world-class scientific team and establish cutting-edge infrastructure - Access to a global network of advisors and collaborators - Fast-paced learning environment with high ownership and the chance to see your work in market-ready products - Competitive compensation package with equity participation - Collaborative and dynamic team committed to long-term success,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
pune, maharashtra
On-site
As a member of our team, you will be responsible for the synthesis and purification of assigned molecules/experiments. You will also actively participate in process development activities for the assigned molecule, as well as provide support for scaling up developed processes in the pilot plant and large-scale manufacturing processes. Your role will be crucial in ensuring complete support for Tech Transfer activities by closely collaborating with cross-functional teams. An essential aspect of your responsibilities will be to add value to processes through innovation. You will be expected to understand and analyze reports received from the Analytical department, which may include NMR, Mass Spectrum, IR, HPLC, GC, among others. Additionally, you will work closely with the Analytical Development Laboratory (ADL) to process samples for analysis as per the project requirements. Your expertise and dedication in these areas will be pivotal in contributing to the success of our projects and the overall efficiency of our operations.,
Posted 2 weeks ago
4.0 - 8.0 years
0 Lacs
karnataka
On-site
As a Product Development Scientist at our company, you will be responsible for executing lab batches for Solid Orals and liquid orals, which includes formulation strategy, process selection, drug excipients compatibility, lead formulation selection, stability studies, and tech transfer in accordance with applicable regulations and ICH guidelines. You will also play a key role in advancing new formulations from idea generation through development and scale-up. Your primary task will involve evaluating and implementing ICH and Quality by Design (QbD) concepts during the Product development phase. This includes considering elements such as Quality Target Product Profile (QTPP), Critical Quality Attributes (CQA), Critical Process Parameters (CPP), Critical Material Attributes (CMA), and Design of Experiments (DOE). To excel in this role, you should possess strong problem-solving, analytical thinking, and communication skills. Additionally, you should hold an M.Pharm degree in Pharmaceutical Sciences or Pharmaceutics and have 4 to 7 years of relevant experience in the field. If you meet the qualifications and are excited about this opportunity, please send your CV to hr@lyruslife.com with the position you are applying for mentioned in the subject line.,
Posted 2 weeks ago
1.0 - 6.0 years
2 - 3 Lacs
vadodara, panoli
Work from Office
1. API synthetic process tech transfer to plant and scale-up at plant. 2. BMR and scale-up documents preparation. 3. Process Validation 4. Plant batch trouble shooting 5. Production of API at plant. Required Candidate profile 1. Knowledge of process development and tech transfer 2. API plant working experience 3. Working experience in pharma company with good production knowledge. 4. Knowledge of GMP
Posted 2 weeks ago
4.0 - 12.0 years
0 Lacs
hosur, tamil nadu
On-site
You are invited to apply for the position of Junior Executive- Tech Transfer at a leading pharmaceutical company located in Hosur, Tamil Nadu. The ideal candidate should possess a minimum of 4 to 12 years of experience in the pharmaceutical industry and hold an M.Pharma degree. Your main responsibilities will revolve around the tech transfer and site transfer products. This will include participating in batch execution activities, reviewing necessary documents, and applying for test licenses. You will also be tasked with ensuring the availability of item codes for raw materials, primary packaging materials, filters, and tubings. Additionally, you will need to conduct gap assessments for products and equipment, prepare manufacturing records, and design protocols for post-execution studies. Collaboration with various departments within the organization is essential to meet project objectives. You will be responsible for raw material indenting, specification generation, trade dress approval support, and participating in submission batches for dossier extension markets. Addressing queries related to tech transfer products, maintaining laboratory notebooks, and providing support for capital goods requisition are also part of the role. Furthermore, you will be involved in literature and patent searches, as well as maintaining API and RLD registers for reconciliation purposes. The upkeep of the FR&D laboratory, including the raw material store, primary packing material store, and finished goods storage area, will fall under your maintenance responsibilities. If you are enthusiastic about this opportunity and possess the required qualifications and experience, please share your updated CV with us at praveenkumar@bvrpc.com.,
Posted 2 weeks ago
2.0 - 4.0 years
2 - 5 Lacs
surat
Work from Office
Role & responsibilities Plan and execute pilot plant operations . Handle pilot-scale equipment. Support process optimization to improve yield, purity, cycle time, and cost. Execute and monitor technology transfer from R&D to pilot plant and production. Identify and troubleshoot process deviations and suggest corrective actions. Maintain BMRs, logbooks, and process documentation in line with GMP and regulatory requirements. Ensure equipment readiness, cleaning validation, and calibration compliance. Coordinate with cross-functional teams (R&D, QA, QC, Production, EHS) for smooth project execution. Ensure adherence to safety, health, and environmental practices at all times. Preferred candidate profile Strong knowledge of organic chemistry, unit operations, and process chemistry. Hands-on experience with pilot plant operations and scale-up studies. Good understanding of GMP documentation and regulatory requirements. Problem-solving and troubleshooting ability in process operations. Strong focus on EHS practices and safe plant operations.
Posted 2 weeks ago
3.0 - 8.0 years
4 - 8 Lacs
mumbai
Work from Office
Responsibilities: Operation Control and Monitoring Multiple CMO Sites. Check Plan Vs Achievement on a regular basis. Provide information to Production coordinator daily via Daily Performance report. Check availability of resources at contract site to meet schedule. Check documents availability in case of change in product. Provide batch no. requisition to coordinator as per plan. Ensure timely SAP posting and dispatches. Monitor Schedule OTIF. OTIF Tracking at respective CM sites, On Time in Full (OTIF) delivery Supply deliveries as volumes committed & requirement. To Co-ordinate with Stores and contract manufacturing site for the timely shortages, availability, and release of RMs and PMs. Follow-up for release of RM's/PM's & FG as defined times lines. Ensure availability of change parts and tooling as per product specification and coordinate for new product launches with New product launch team. Planning and tracking deliveries to avoid Loss of Sales/Stock out situation. Follow up with different CM sites for delivery Commitment of current month and material status for rolling month’s plan. Implementation & Tracking of Changes if any for Artwork/Packing materials /Quality improvement Changes/MRP etc. for Unit. Sorting out the Daily SAP & eMRP portal related issues at site. Trouble shooting in production & packing. Coordinating for Stock audits and inventory Audits. Check practices at contract site for Cipla quality policy. Check products manufacturing as per Cipla BMR/BPR Check in process checks and machine performance. Provide quality observations and check CAPA implementation at CMO’s. Check line clearance practices and provide insight to Production coordinator. Check BMR/BPR and provide product review sheet to Production coordinator for Batch release. Provide packing list in case of export order. Review quality of products at CM Sites in compliance with cGMP requirements and Cipla quality policy. Corporate(1035-G-0047/F5/4) Review & reporting any noncompliance during routine observation & ensuring the compliance through proper tracking & CAPA. Provide training to the location staff and workmen on current Good Manufacturing Practices (need basis) and data integrity Practises. Check implementation progress with respect to upgradation of Site. Check compliance of open audit & review point & submit report to coordinator and FPS compliance team. Implement CAPA taken on deviations/ changes controls/ market complaint. Identify bottle neck during planning and mitigate it. Ensure availability of all product document, change parts (punches & packing change parts) in time with coordination with coordinator. Execute tech transfer PV batch manufacturing in presence of tech transfer person to ensure for timely supply. Review filled documents (BMR/BPR, PV report and FG COA). Coordinate for Launches of New product at CMO sites with necessary information. Monitor and Guide the Cipla Executive & Sr. executives at CMO locations. Quality Management System Procedure and evaluating the impact of change. To operate the Cipla Quality Management System – LMS on the Roles and Rights provided in the application. Ensure the compliance of any deficiencies raised by Quality Assurance during batch record review. To participate in the implementation and monitoring of Quality System and Quality Policy To ensure timely and effective communication to Senior Management. Follow up and implementation of suggestion or corrective actions suggested by Senior Management, continual improvement of the Quality System. GMP (Good Manufacturing Practices) To ensure compliance with respect to supply chain management and Good Distribution Practices. Ensuring that all transporting vehicles meet requirement of current Good Manufacturing Practice (cGMP) and Good Manufacturing Practice (GMP) requirements of country where product is being exported by agreements. Responsible to ensure online entry and retention and destruction of records as per Standard Operating Procedure (SOP). To Monitor handling, storage, and clearance of rejected materials. Training Identification of training needs and evaluation of training at LL sites as per Cipla Quality Procedures. Rendering FPS induction to new entrants, verifying the On Job Training Evaluation and Training. To operate the Learning Management System (LIMS} based on the Roles and Rights provided in the application
Posted 2 weeks ago
5.0 - 9.0 years
0 Lacs
assam
On-site
You will be joining Repligen, a bioprocessing-focused life sciences company with over 30 years of expertise in inspiring advances in bioprocessing through the development and commercialization of high-value products and flexible solutions for the production of biologic drugs. As a US-based Field Application Scientist, your primary responsibility will be to provide technical support for the upstream product lines in the bioprocess industry. Drawing on your knowledge of cell culture process development, filtration, and manufacturing, you will collaborate with customers and the sales team in both pre- and post-sales activities. In this role, you will closely collaborate with various Repligen teams, including sales account managers, product management, quality assurance, and R&D scientists/engineers, to ensure that our products effectively meet the evolving needs of our customers in the bioprocessing industry. This position is field-based on the US east coast and will involve domestic and occasional international travel. Ideally, the role will be based in the greater NY area (NY, NJ, CT, PA). Your key responsibilities will include: - Collaborating with the sales team and product management to support customers for various product lines - Developing and executing project plans using Repligen technologies - Drafting technical protocols/reports from customer interactions - Providing feedback to product management and R&D for product improvement - Contributing to applications data and collateral generation by working with R&D and marketing To be successful in this role, you should possess: - A Bachelor's degree or higher in a scientific (biology/biochemistry) or engineering (chemical) field - 5+ years of experience in a cell culture discipline in the bioprocessing industry - Strong interpersonal, communication, and problem-solving skills - Ability to work independently and prioritize tasks effectively - Proficiency in English (writing and speaking) and willingness to travel domestically and occasionally internationally At Repligen, we offer a competitive compensation package that includes variable cash programs, equity for eligible roles, paid time off, health/dental/vision benefits, retirement benefits, and flexible spending accounts. Specific compensation and benefits details will be provided in writing at the time of offer, aligning with market data and individual qualifications. Join us in our mission to drive advancements in bioprocessing and improve human health worldwide.,
Posted 2 weeks ago
3.0 - 7.0 years
0 Lacs
maharashtra
On-site
As a Process R&D Scientist in the Organic Chemistry field, your main responsibility will be to develop, optimize, and execute processes for APIs to ensure timely implementation within budget constraints. You will need to conduct a literature survey and route selection for assigned projects, prepare and execute development strategies, and maintain records of experiments carried out in the lab. Your role will involve optimizing process parameters to achieve robustness and support the creation of new IP assets by performing experiments related to innovations such as new processes and polymorphs. Additionally, you will be responsible for preparing development reports and tech transfer documents based on the work carried out in the lab, coordinating with manufacturing units for pilot and validation batches, and conducting studies to achieve regulatory compliance. Vendor qualification for key raw materials, compliance with stage gate and milestone meetings checklist, and addressing challenges such as delays in analytical results and re-conducting experiments are also part of your key accountabilities. Your interactions will primarily be with manufacturing, SCM, ADL, QA, QC, IP, ROC, safety, and engineering teams as well as vendors and suppliers. The dimensions of your role include process development for multiple projects and execution of processes on the plant for specific projects. Key decisions you will need to make include the use of specific reagents, solvents, reaction conditions, route selection for development, and selection of vendors for raw materials, instruments, and equipment. To qualify for this role, you should have an M.Sc. in Organic Chemistry and possess 3-5 years of relevant work experience in process R&D.,
Posted 2 weeks ago
1.0 - 4.0 years
3 - 7 Lacs
bengaluru
Work from Office
Our vision for the future is based on the idea that transforming financial lives starts by giving our people the freedom to transform their own We have a flexible work environment, and fluid career paths We not only encourage but celebrate internal mobility We also recognize the importance of purpose, well-being, and work-life balance Within Empower and our communities, we work hard to create a welcoming and inclusive environment, and our associates dedicate thousands of hours to volunteering for causes that matter most to them, Chart your own path and grow your career while helping more customers achieve financial freedom Empower Yourself, A Software Engineer is responsible for designing, developing, and maintaining software applications They play a crucial role in the entire software development lifecycle, from requirements analysis to deployment, and ongoing support, Essential Functions Design, code, and test software features and components, Collaborate with cross-functional teams to gather and refine software requirements, Lead coding efforts for specific modules or features, Troubleshoot and resolve complex software issues, Participate in code reviews and enforce coding standards, Contribute to architectural decisions and design discussions, Qualifications Bachelor's degree in computer science or equivalent training, 3+ years of experience in software development, Proficiency in one or more programming languages such as Java, Python, Swift, JavaScript, or similar, Strong understanding of software development methodologies and best practices, Problem-solving, debugging, and troubleshooting skills, Excellent teamwork and communication abilities, Experience with Agile principles preferred Experience across multiple projects and development cycles preferred This job description is not intended to be an exhaustive list of all duties, responsibilities and qualifications of the job The employer has the right to revise this job description at any time You will be evaluated in part based on your performance of the responsibilities and/or tasks listed in this job description You may be required perform other duties that are not included on this job description The job description is not a contract for employment, and either you or the employer may terminate employment at any time, for any reason, as per terms and conditions of your employment contract, We are an equal opportunity employer with a commitment to diversity All individuals, regardless of personal characteristics, are encouraged to apply All qualified applicants will receive consideration for employment without regard to age, race, color, national origin, ancestry, sex, sexual orientation, gender, gender identity, gender expression, marital status, pregnancy, religion, physical or mental disability, military or veteran status, genetic information, or any other status protected by applicable state or local law,
Posted 2 weeks ago
5.0 - 10.0 years
6 - 8 Lacs
coimbatore
Work from Office
KEY RESPONSIBILITIES: Develop new processes, or refine existing ones, to optimize the scale up of lab batches in factory. plan, carry out and supervise process trials in laboratories & pilot trials. Develop tech transfer documents along with formulation team. Plan the scale up batches aligning with stakeholders. scale up the production process via trials, making changes to raw materials or components, and process parameters to ensure quality is maintained during large-scale production. To run the stability studies of pilot batches, assist the lab team in running stability studies. work with product pipelines at various stages of development and provide guidance on scalability. develop formulae specifications by taking pilot trials. advise on equipment modification to enable process changes for new product development. read and write technical reports and specifications, maintaining appropriate records. initiate and generate ideas based on reading and research. Adhere to GMP practices. Adhere to safety & quality standard operating procedures. Identify and Implement Process improvement projects. Follows and supports current Good Manufacturing Practices and current Good mfg/Laboratory Practices Cross-functional collaboration: to work closely with R&D, Quality Assurance, Quality Control and Manufacturing SKILLS: a. scale up of lab batches in factory. b. Read and write technical reports and specifications. c. Experience in cosmetic production facility, worked as manufacturing chemist handled production d. Having good exposure on ISO 9001-2015 & ISO 22716 requirements e. Mastery of office tools such as Excel, Word, Power Point, and Sharepoint f. Problem-solving mindset g. Excellent communication
Posted 2 weeks ago
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