15 Pdr Jobs

Candidate should perform literature search Should have some basic understanding of patent and generic formulation development. Characterization of marketed product wrt market requirements Pre formulation development Required Candidate profile Vacancies – 4 – 5 Experience -5years +- 10years Location : Mumbai Andheri Must have FD Solid Dosage Us market exp

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

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.

Role & responsibilities: Preferred candidate profile :

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

Roles and Responsibilities Develop new products by formulating, developing, and launching solid oral products. Conduct bioanalytical testing to ensure product quality and stability. Collaborate with cross-functional teams for process development, PDR (Process Development Research), MFR (Manufacturing Formulation Research), FD Trial (First Time Right Trial). Ensure compliance with regulatory requirements through documentation of SOPs, BPRs, and batch records. Provide technical support to production team on product-related issues.

Characterization of marketed product wrt market requirements Knowledge of ICH stability conditions and compilation of analytical data Preparation of documents like PDR, stability protocol, development report writing FDR/PDR Required Candidate profile Candidate should perform literature search Looking candidates for PDR (Formulation & Development ) Dept. Candidate should have experience in solid oral dosage (Regulated Market- USA/EU/ South Africa)

Urgent opening for Executive/Sr.Executive- FR&D (Topical Dosage) Roles & Responsibilities: 1. Experience on Topical dosage form formulation development Conduct Develop prototypes trials, proof-of-concept models, and experimental formulations to evaluate feasibility, performance Conduct literature reviews, patent searches, and market analyses to assess the feasibility Maintain accurate and detailed records of experimental procedures, results, and observations, and prepare technical reports like MFC, BMR, PDR, Stability protocol etc Experience on Technology transfer (TT) from R&D to commercial manufacturing site. Raw material indenting, packaging material, dies & punches stock management. Preparation & review of Scale up, Exhibit &Validation batch documents such as BOM, BMR, BPR, PVP & PVPR. Collaborate with cross-functional teams to gather and analyze data. Assist and support to plant team and cross functional team in scale-up of new products technology Summarize and document results in LNB , prepare technical reports Maintain clean working laboratory environment and suitable working equipment. Perform general lab assignments (e.g. raw material inventory review, lab instruments) as assigned. Interested Candidate may send their resume to audrey.fernandes@marksanspharma.com

Looking candidates for PDR (Formulation & Development ) Dept. 2-7 years of relevant experience in solid oral dosage (Regulated Market) Roles and Responsibilities 1.Candidate should perform literature search 2.Pre formulation development Required Candidate profile 1.knowledge of documents – Master formula card, Bill of Material, stability protocol 2.Preparation of various documents like PDR, stability protocol, development report writing FDR/PDR

Medicamen Biotech - SRL Pharma R&D Centre Required Formulations Profile Designation: Executive/ Scientist Qualifications: M. Pharma - Pharmaceutics Vacant Post: 6 Nos. Experience: 4 to 8 Years Please share profile on uday@shivalikrasayan.com Required Candidate profile Pharma R&D experience must in Formulation USFDA exposer prefer Preparation of Pharmaceutical Development Report Ready to relocate Bhiwadi, Rajasthan Ready to join Immediately Prefer Team Player Perks and benefits Best of Industries Salary based on Experience

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Role & responsibilities RM and PM receiving and documentation of the same. Proper arrangement of the Received COA of RM and PM. Sampling of Received RM and PM, sending the samples to ADL for analysis. Preparation of indent for trial activity and ensure the availability in defined time. Taking of daily trial batches, discussion of issue with immediate supervisor. Entry of trial batch data in lab notebook and preparation of BMR for stability batches. Maintaining the files of individual products like RM and PM COA, Trial COA and Stability Reports after updation in Excel Sheet. Ensure GMP practice in Laboratory routinely. Documentation of stability batches. Calibration of instruments in the laboratory. Literature search and review for the newly identified products for EU/UK/Raw market. SOP preparation and submission to DQA. Ensure utility in good condition in laboratory during all development batches. Adhere Good Manufacturing Practice and Good Laboratory Practice throughout lifecycle of the product. Preferred candidate profile Should have exposure to Formulation & Development of Injectable products knowledge for regulatory market preferable along with regulatory documents preparation like PDR, MFR etc. If having basic knowledge of injectable products is added advantage.

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

Good understanding on formulation & Development for regulated market/Should have experience on product technology transfer at plant side/ Knowledge on QBD,Good documentation practice/literature survey/ICH guidelines/ Solid Oral/Injectables/ OSD Required Candidate profile Execution of process evaluation, optimization, scale-up and exhibit batches. Meeting product development timelines/ Solid Oral/ Injectable Candidate can share their CV on stuti.naik@enaltec.com

KEY RESPONSIBILITIES: Following are the job responsibilities for Development Quality Assurance. Review of analytical documents like Residual solvent statement, Risk assessment for Elemental impurities etc. generated during the product development at Injectable R&D. Review & Approval of Analytical method (including Extractables and Leachables) validation protocols & Reports (Including review of Raw Data). Review of all the protocol based studies related to Extractable and Leachables. Review of Protocol and Report related to Peptide Characterization. Review and approval of R&D specifications, GTPs and other documents. Review and approval of formulation and analytical study protocols and reports. (Equipment Qualification, Submission documents like Justification for specification, Residual Solvent Assessment and Elemental Impurities, Compatibility studies). Review of the logbook and register for completeness and correction as per Good documentation practices and cGMP norms. Review of Filter Validation Study Protocols and Reports. Review & Approval of Master Formula Record (MFR). Review of Product Development Report (PDR). Participation in incidences, investigation & CAPA review and approval. Review method validation protocols and reports for products to be executed at contract manufacturing or research organization. Review & approval of Computer system validation documents as per the defined procedure Review of IT related documents with respect to respective SOP