12 Ndds Jobs

Lead formulation and process development of HFA-based MDI products for regulated markets (US, EU, etc.). Manage drug-device combination product development , including coordination with device vendors for CMC and regulatory compliance. Coordinate cross-functionally with analytical, regulatory, clinical, and manufacturing teams to ensure timely project execution. Drive process optimization at the lab scale using QbD principles; establish control strategies for successful scale-up. Design and define product specifications in compliance with current global regulatory guidelines. Review Product Development Reports, Technology Transfer Reports , and Deviation/Investigation Reports for technical accuracy. Support regulatory query responses related to product development and manufacturing in collaboration with relevant departments. Lead technology transfer of HFA-based MDIs to contract manufacturing organizations (CMOs) for domestic and international markets. Provide technical and regulatory support for submissions including NDA, ANDA, and 505(b)(2) applications. Troubleshoot formulation-related issues during manufacturing to ensure smooth and compliant commercial production.

Patent Portfolio Management Patentability Assessment Patent Drafting & Filing (India and International) Patent Prosecution & Examination Response Handling Patent Landscape and Infringement Analysis Freedom to Operate (FTO) Analysis IP Enforcement Strategy & Infringement Notice Preparation Knowledge of Patent Laws (India, US) IPR Documentation: Counterclaims, Written Statements, Evidences Expertise in Patent Search Databases (e.g., Derwent, Patsnap, Orbit, etc.) Technical Patent Search: API, NCE, NDDS, Formulation, Technology

As a Formulation and Development Officer for our client based in Vatva, Gujarat, you will be responsible for various key tasks. Your primary duty will involve the development of formulations for all dosage forms such as tablets, capsules, ointments, creams, gels, oral liquids, injectables, and novel drug delivery systems for different markets including regulated, domestic, and ROW markets. This includes activities like document review, planning, and conducting stability studies of R&D batches. Additionally, you will be required to provide technical support for the scale-up and technology transfer to manufacturing processes. You will play a crucial role in troubleshooting formulation-related issues that may arise during production, ensuring a smooth manufacturing process. To qualify for this position, you should hold a Bachelors or Masters degree in Pharmacy. If you believe you possess the necessary qualifications and skills for this role, we encourage you to share your updated CV with us. We look forward to reviewing your application and will reach out to you promptly.,

Alembic Group is looking for Junior Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey They work under the guidance of senior executives and managers to support the organizations goals and objectives Must have excellent written and verbal communication skillsMust be able to analyze complex problems and develop effective solutions Managing internal and external communication, including preparing reports, presentations, and other materials

Alembic Group is looking for Executive - Formulation Development to join our dynamic team and embark on a rewarding career journey Assisting with the preparation of operating budgets, financial statements, and reports. Processing requisition and other business forms, checking account balances, and approving purchases. Advising other departments on best practices related to fiscal procedures. Managing account records, issuing invoices, and handling payments. Collaborating with internal departments to reconcile any accounting discrepancies. Analyzing financial data and assisting with audits, reviews, and tax preparations. Updating financial spreadsheets and reports with the latest available data. Reviewing existing financial policies and procedures to ensure regulatory compliance. Providing assistance with payroll administration. Keeping records and documenting financial processes.

Role & responsibilities Clinical trial designing, protocol inputs for generic products and their FDCs The position is to Lead team of scientists to accomplish activities related to clinical trial designing, monitoring, concluding and MMA. Phase trials I IV execution. NDDS product development. Define objectives/ sample size calculation for protocols of clinical trials. AE/ SAE monitoring & reporting. Site selection/ site evaluation. Training to investigators, guide the trial site for execution of the study as per expectation of protocol. Preferred candidate profile MD (Pharmacology) with 2-4 yrs of relevant experience. Interested candidates are requested to share their CVs on vilshashah@torrentpharma.com

Plan, setup, monitor, and workup chemical reactions independently Monitor progress of the reactions by using standard methods and analytical techniques (TLC, GC, HPLC, LCMS etc) Isolate product and Optimize reaction conditions for improved yields and output Purify compounds by different methods using chromatography, distillation and crystallization etc. Characterization and identification of compounds using UV, IR, NMR, LCMS and GCMS etc Ensure parallel execution of multiple reactions conducted both by self and the team Scale up of R&D developed products to kg scale and then technology transfer to pilot plant Troubleshoot as appropriate for successful execution with intimation to supervisorautomation Writing regular updates, final reports, PDR preparations and inter departmental communication

Role: Network Planner and Documentation. Skills Required: - Should have good knowledge on CIENA Hardware specifications and product know-how and its use in different solutions, Experience is mandatory in CIENA products OME6500 (L1&L0), 6500RLS. - The person should be aware of all deployment activities on CIENA products such as I&C, Nodal ATP, Channel ATP, Service provisioning, Link Testing, etc. - The Person should have good knowledge and hands-on experience to create Network diagram, DCN diagrams, Signal Flow diagrams (SFD) , Rack front view (RFV), NDDs, RFL (Running fiber list), Commissioning sheets, Channel plan etc. - The person should have good experience in doing planning of DCN designs and Network designs based on Planning files provided by System Engineering team. - He should possess good technical ability to understand different type of CIENA solution deployed in customer networks in India. - He should be able to Lead the account independently, talk to internal teams (PM, PSE) and customer planning teams take the input and provide the response within time. - He should possess good verbal and written skills to communicate effectively on Critical issues. - Should have good knowledge on MS-EXCEL, VISIO - Should have at least 4-9 Years of relevant experience. Educational requirement: - Should be B.E or equivalent Degree course - Should have hands on Experience on planning and documentation. - Should have worked on different Optical solutions

Drive development of innovative probiotic, nutraceutical, herbal and natural-based formulations Align R&D strategy with business goals Work on solid orals, sachets, liquids, and novel delivery systems Lead a young dynamic team of R&D scientists Required Candidate profile Decent experience in probiotic/nutraceutical/innovative formulations Passionate about creating breakthrough, evidence-backed products

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

Role & responsibilities Operation & calibration of Instruments in Laboratory. Analysis & report compilation of In-process samples, Stability samples, Finished products & Raw materials. Preparation of chemicals & reagents required for day-to-day analysis. Preparation & filtration of Mobile phase Preparation & standardization of volumetric solutions Stock checking & inventory of chemicals required for day to day Stock checking & inventory of chemicals required for day to day Responsible for Stability samples (Loading and unloading) under supervision. Assisting in Media preparation Preparation of solution for Plasma samples deactivation. Assisting other lab related works. Must Have Master's degree (M.Sc. or M. Pharm) in Chemistry, Pharmaceutical Sciences, Analytical Chemistry. Understanding of pharmaceutical formulation Good knowledge of written and oral communication skills for technical documentation. Time management skills to plan and executive analytical development activity.

Job Description : - Department - Injectable Mfg & Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 6 Education - ITI / Diploma Eng / D.Pharma / B.Pharma / M.Pharma Skill Set - Require good knowledge in Complex Skid / NDDS / Aseptic (PFS / Vials Liquid) / Autoclave/ Lyopholizer / Batch Manufacturing, Sterile Secondary Packing and track and trace activity + visual inspection activity. Department - QC ( QC FG / Stability / AMV ) Position - Officer to Executive Exp - 2 to 7 Education - M.Sc / B.Pahrma / M.Pharma Skill Set - Analyst : Finished, AMV & Stability Section. knowledge of Instrument - HPLC / GC. Preferably know-how of Chromeleon Software Department - Engineering ( Plant Maintenance Sterile / Instrumentation Sterile ) Exp - 2 to 15 Position - Technician / Executive / Assistant Manager / Manager Education - Diploma Eng / ITI / B.Tech Skill Set - Have good exposure in Plant Maintenance & Instrumentation related work in sterile facility Department - QA ( IPQA / Qualification (Sterile Background Only) Position - Officer to Executive Exp - 2 to 7 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Have good exposure in Sterile IPQA & Sterile Qualification Related activity Department - Lab QA Position - Officer to Sr. Executive Exp - 2 to 9 Education - B. Pharmacy / M.Pahrma / M.Sc Skill Set - Having good exposure of QC QMS handling , Lab instrumentation & audit trails. Have strong background of Lab QA activity. Department - Solid Oral Packing Position - Technician / Officer / Sr. Officer Exp - 2 to 5 Education - ITI / Diploma Eng / D.Pharma / B.Pharma Skill Set - Require good knowledge in Primary & Secondary Packing, Track & Trace, Carton Packing Machine (CAM HV1 Model), Online Documentation BPCR / Logbook etc.