6 Protocol Preparation Jobs

You are invited to join Horizon Biolabs Pvt Ltd., a GLP compliant Pharmaceutical Testing Laboratory based in Hyderabad, India. We are a global leader in providing laboratory testing services in Chemical and Microbiological segments for the pharmaceutical, biotech, and medical devices industries. We are looking for candidates with an MSc in Microbiology and a minimum of 6 months to 1 year of experience in a reputed Pharma Testing Lab, CRO, or Pharmaceutical Industry. Your responsibilities will include conducting Microbial enumeration tests, Antimicrobial Effectiveness Test (AET/PET), Sterility, Bacterial Endotoxin Test (BET by Gel Clot), Environmental Monitoring, Microbiological Assays, and Water validation. You should also have experience in protocol preparation, report preparation, and Method Validations. As a Microbiologist at Horizon Biolabs Pvt Ltd., you will oversee and manage all microbiological activities, supervise a team of microbiologists, review and interpret test results, identify process improvements, maintain documentation, collaborate with cross-functional teams, and ensure compliance with regulatory requirements. You will be the single point of contact for day-to-day operations in the Microbiology Laboratory and will represent the laboratory during customer and regulatory audits. This is a full-time position with benefits including Provident Fund. The work schedule is a day shift, and the work location is in person at our facility in Hyderabad, India. The application deadline is 05/04/2025, and the expected start date is 10/04/2025. If you meet the requirements and are ready to take on this exciting opportunity, we look forward to receiving your application.,

As a Research Scientist1 DMPK at the Foundation for Neglected Disease Research in Bengaluru, you will play a crucial role in supporting drug discovery and development projects by performing and analyzing in vitro and in vivo DMPK studies. Your responsibilities will include planning, designing, and executing DMPK experiments, maintaining laboratory instruments, and preparing protocols. Additionally, you will be tasked with writing reports, communicating with the project team, and presenting DMPK data during project meetings. Your technical skills will be put to the test as you set up and conduct physiochemical assays, in vitro DMPK assays, and bioanalytical methods. Your experience in analyzing in-vivo pharmacokinetic samples and familiarity with sample processing techniques will be invaluable. Proficiency in handling LC-MS/MS for quantitative analysis, protocol preparation, and report writing is essential for this role. Moreover, your additional experience in animal handling, conducting PK studies, and working with cell lines such as Caco-2 will be advantageous. Knowledge of interpreting pharmacokinetic data using Phoenix WinNonlin and operating in a GLP or GLP-like environment will also be beneficial. Basic skills required for this position include working independently with enthusiasm, strong decision-making and problem-solving abilities, effective collaboration across multidisciplinary functions, and knowledge of drug discovery and development processes. Excellent oral, written, and interpersonal communication skills in English, along with proficiency in computer applications, are essential for success in this role. To be considered for this position, you must be an Indian citizen with an M.Pharm, MS (Pharm), or PhD qualification and possess 2 to 5 years of industry experience. The salary offered will be commensurate with your experience. If you meet the qualifications and are excited about this opportunity, please submit your resume to hr@fndr.in with the subject line "Application for Research Scientist 1 DMPK," including your notice period, current location, and current and expected CTC in the body of the email. We look forward to receiving your application.,

The key responsibility of the candidate will be to perform and analyze in vitro and in vivo DMPK studies to support drug discovery and development projects. You will be involved in planning, designing, and setting up DMPK experiments, handling instruments, maintaining the laboratory, and preparing and reviewing protocols. Furthermore, you will be responsible for writing reports, communicating with the project team, and presenting DMPK data in project meetings. Required technical skills include the ability to set up and perform physiochemical assays such as solubility and logP, experience in conducting in vitro DMPK assays (microsomal and hepatocyte stability, plasma stability, CYP inhibition, blood/plasma ratio), development and validation of bioanalytical methods across various biological matrices, analysis of in-vivo pharmacokinetic samples, knowledge of sample processing techniques (protein precipitation, liquid-liquid extraction, solid-phase extraction), proficiency in handling LC-MS/MS for quantitative analysis, protocol preparation, report writing, and presentation of DMPK data in scientific team meetings. Additional skills that would be beneficial for this role include experience in animal handling, conducting pharmacokinetic (PK) studies, working with cell lines such as Caco-2, ability to interpret pharmacokinetic data using Phoenix WinNonlin, experience in a GLP or GLP-like environment. Basic skills required for this position include the ability to work independently with enthusiasm and self-motivation, strong decision-making and problem-solving skills, effective collaboration and teamwork across multidisciplinary functions, knowledge of drug discovery and development processes, excellent oral, written, and interpersonal communication skills with proficiency in English, and proficiency in computer applications including word processing, spreadsheets, and presentation tools. Qualifications for this role include an M.Pharm or MS (Pharm) or PhD degree, industry experience of 2 to 5 years, and the candidate must be an Indian citizen. Salary will be commensurate with experience.,

Role & responsibilities Job Responsibilities/Descriptions Primary Responsibilities: 1. To ensure shop floor compliance of Visual Inspection, Packaging, warehouse and Dispatch operations as per cGMP and cGWP requirements (IPQA activities). To prepare and review SOPs, study protocols, SPRs, TPRs pertaining to Fill finish, warehouse and quality assurance as required. 3. To Support in visual inspection qualification kits and visual inspection operator qualifications. 4. To review the trends of visual inspection results. 5. To support the Validation Team during the qualification activities at the area. 6. To provide Line Clearance for Visual Inspection, Packaging, Dispensing and Dispatch operations, verification of In-Process checks as defined in the batch records / SOPs. 7. To perform AQL Visual Inspection of filled units as per SOP / instructions. 8. To perform Pre-Dispatch Inspection (PDI checks). 9. To verify and ensure routine compliance of Visual Inspection and Packaging activities as per the batch records/SOPs and verification of the online documentation against each process stage, including logbooks 10. To Suppott Artwork development and management. 11. To Support in Transport Validation of Finished Products. 12. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to Visual Inspection and Packaging areas, support investigations. 13. To co-ordinate with all cross functional departments for operations related to Quality Assurance. 14. To ensure the readiness of shop floor for audits by Regulatory Authorities / customers. 15. To support market compliant investigations. 16. Ensure to perform daily random checks on material reconciliation at warehouse and report the discrepancy. 17. Ensure the warehouse documents verification and its compliance. 18. To Support and facilitate timely closure of Change Controls, Events / Deviations, CAPA pertaining to warehouse and Dispatch areas; support investigations. Secondary Responsibilities: 19. Follow the safety precautions at packing and warehouse areas. 20. Support the internal audits. 21. Any other responsibilities assigned by supervisor / head of the department.

Excellent opening for Process Validation role in Quality Assurance in Unison Pharmaceuticals, Moraiya Company: Unison Pharmaceuticals Website: www.unisonpharmaceuticals.com Department: Quality Assurance Location: Unit III, Moraiya, Ahmedabad Designation : Process Validation: Executive/Sr. Executive Experience: 3-9 Years (In PV) Qualification: B.Pharm/M.Sc Job Description : Prepare process validation protocol and send for review, approval and authorization to concern team members Facilitate process validation training to production, QC and IPQA Collect samples from Granulation, Compression / Capsule filling and Coating stages and send to QC for analysis Perform required documentation activities like; utilization log and test request slip Compile data for each batch performed under validation stage Prepare process validation report post completion of the 3 validation batches and send the report for review and approval Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Role & responsibilities Preparation and maintenance of training records To prepare specification and method of analysis as per requirement Preparation of protocols and reports Change Control, Analyst Qualification To support lab activities including analysis for method development and validation activities To ensure compilation and maintenance of logbooks for analysis done by HPLC Maintenance of records (user account, service records, sample request of samples) Ard Interested one can share updated resume on Whatsapp at 9915095113 or email at manik.mehta@scllifesciences.com