13 Peptides Jobs

Position: Senior Manager - Peptide Production Grade: G9B / G9A Job Location: Ahmednagar Qualification: M.Sc. (Chemistry) / B.E. (Chemical) / B.Tech (Chemical) Experience: 13-18 yrs experience in Peptide API plant Job Profile 1. To plan and execute peptide manufacturing activities as per the schedule and Budget by optimum utilization of plant capacity 2. To ensure the sustainable quality production with optimum utilization of plant capacity. 3. Monitoring and reduction in process TRT, Cleaning TRT, number of preps per batch on Prep HPLC, Improve yields. Improve the process of Synthesis & Analytical Section. 4. Co-ordinate with Purchase, Planning department to deliver the goods in time. 5. To ensure every day interaction with each department for smooth functioning 6. Compliance of waste water disposal as per IN-HOUSE policy 7. To ensure grooming of disciplined workforce and staff to meet the planned growth charts. 8. Developing different innovative practices to increase productivities and up gradation of work culture. 9. To maintain Good Documentation Practices and Good Laboratory Practices 10. Review of batch process record, Standard Operating procedure and cGMP documents 11. Investigation of Deviation, Change Control & OOS 12. Implementation & follow all safety instruction & practices

Role & responsibilities Incumbent should possess design development know-how of peptide APIs Should have hands on experience in synthesis and purification of peptides and complex generics. Exposure on scale-up, technology transfer and manufacturing of peptide APIs Experience of impurity profiling (process and product related) Must have experience of technical documents preparation and to support regulatory filing Preferred candidate profile M.Tech/M.Sc./Chemical Engineering/Biotechnology degree or equivalent. 15+ years of post-qualification experience in the Peptides field, with a focus on new technologies and PAT (Process Analytical Technology) tools. Experience in operational excellence and Six Sigma methodology will be an added advantage.

Responsible for Collection, compilation, analysis, and review of all data for APQR Responsible for Processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow Responsible for Review/approval of all documentation associated with the process validation, CPV & cleaning validation Must have experince in Peptide Synthesis. Responsible for processing of documents through the generation, modification, review, and approval and archival of records Responsible for review/approval of all documentation associated with the GMP equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents Responsible for tracking, trending, and reporting of Quality Metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations Responsible for Review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents Responsible for Review of regulatory and quality compliance requirements and divisional policy, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability Quality support to Regulatory Affairs as it relates to updates/changes to Market Authorizations Responsible for Management, tracking, and/or performance of GMP type training supporting plant performance and Quality Departmental training and hands on qualification Responsible for Review/approval of the Validation Master Plan and all documentation associated with the validation or qualification of a process, system, equipment, facility and/or the utilities associated with the site

Role & responsibilities The Senior Principal Scientist Peptide Synthesis will lead the design, development, and optimization of peptide synthesis processes, driving innovation and contributing to the strategic direction of the peptides R&D program. Develop and implement strategic plans for peptide research and development in alignment with organizational goals and objectives. Lead and manage peptide synthesis projects from inception to completion, ensuring timelines, budgets, and quality standards are met. Collaborate with process development and purification teams to ensure seamless integration of peptide synthesis into downstream processes. Preferred candidate profile M.Sc./ PhD in Chemistry, Biochemistry, Pharmaceutical Chemistry or any related field. Minimum 10+ years of hands-on experience in peptide purification.

Role & responsibilities Experience: 9-14 years Specialization: 14 years of experience in Peptides Key Responsibilities: 1 Design and develop formulations for peptide-based drugs, ensuring stability, efficacy, and optimal bioavailability. 2. Conduct research on novel excipients and innovative drug delivery mechanisms tailored for peptide formulations. 3. Lead scale-up and technology transfer of peptide formulations from lab-scale development to commercial production. 4. Coordinate with analytical teams to perform in-depth characterization studies, including stability profiling and compatibility assessments. 5. Ensure regulatory compliance in formulation strategies, preparing CMC documentation for global regulatory submissions. 6. Optimize formulation processes using QbD and DoE approaches to enhance efficiency and quality. 7. Collaborate with manufacturing and production teams to ensure seamless formulation execution at large-scale levels. 8. Conduct pharmacokinetic and bioavailability studies to refine peptide drug delivery strategies. 9. Lead troubleshooting efforts related to formulation challenges, ensuring robust and scalable peptide drug development. 10. Provide technical leadership, mentoring junior scientists, and fostering innovation in peptide drug formulation. Qualifications: Extensive experience in peptide formulation and drug delivery systems. Expertise in stability studies, compatibility assessments, and formulation troubleshooting. Strong understanding of peptide pharmacokinetics, bioavailability enhancement, and absorption mechanisms. Experience with process development, scale-up, and technology transfer for peptide-based formulations. Knowledge of regulatory pathways, GMP compliance, and preparation of CMC documentation. Ability to develop innovative formulation strategies for improved therapeutic performance of peptide drugs. Proficiency in QbD and DoE methodologies to optimize formulation development processes. Preferred candidate profile Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.

Role & responsibilities Experience: 9-14 years Specialization: Oral Solid Dosage with at least 4 years of experience in Peptides Key Responsibilities: 1. Lead formulation development for OSD products, including tablets, capsules, and granules. 2. Develop and optimize stable peptide formulations for OSD applications. 3. Conduct pre-formulation studies, compatibility assessments, and stability testing for peptide-based formulations. 4. Innovate in drug delivery strategies, ensuring enhanced bioavailability and release kinetics for peptide-based OSD formulations. 5. Work closely with analytical teams to characterize formulations using advanced techniques. 6. Oversee scale-up activities, ensuring successful transition from laboratory to pilot and commercial-scale production. 7. Manage technology transfer processes across manufacturing sites to ensure formulation integrity and reproducibility. 8. Prepare and review regulatory documentation, including CMC sections for global submissions. 9. Ensure compliance with GMP standards and regulatory guidelines for peptide drug formulation. 10. Utilize QbD and DoE principles for formulation optimization and process development. 11. Provide scientific leadership and mentorship to junior scientists within the formulation team. Qualifications: PhD/Masters in Pharmaceutical Sciences, or industrial Pharmacy Extensive experience in peptide formulation and oral solid dosage technologies. Strong expertise in excipient selection, stability enhancement, and formulation optimization. Understanding of global regulatory requirements, including expertise in preparing regulatory submissions and ensuring compliance with CMC guidelines. Ability to drive innovation in peptide formulation strategies and drug delivery systems. Preferred candidate profile OSD Experience at least 4 years of experience in peptides Experience of peptide formulation research, including biopharmaceutical characterization and analytical methodologies. l Hands-on experience in scale-up processes and successful technology transfer for peptide-based OSD formulations. l Knowledge of sterile manufacturing principles, which can be beneficial for peptide drugs requiring specialized handling.

Role & responsibilities Understanding business of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Understand the analytical requirements of Biologics, Biosimilars, Vaccines, fusion proteins, peptides Develop and implement strategic sales plans to achieve revenue targets within the biopharmaceutical sector. Identify and pursue new business opportunities with biopharma clients Build and maintain strong relationships with existing clients, understanding their needs and ensuring exceptional customer satisfaction. Collaborate with cross-functional teams including technical experts, marketing, and operations to tailor solutions that meet client requirements. Keep abreast of industry trends, market dynamics, and competitor activities to identify potential opportunities and threats. Prepare and deliver presentations, proposals, and contract negotiations to secure new business partnerships. Provide regular updates and reports on sales performance, market trends, and client feedback to senior management. Ability to work independently and collaboratively in a fast-paced, dynamic environment. Demonstrated ability to think strategically and execute tactical sales plans to drive revenue growth. Preferred candidate profile communication, negotiation, and presentation skills Strong understanding of bioprocessing technologies, clone development, upstream and downstream processing, assay biology, and characterization techniques Willingness to travel as required to meet with clients and attend industry events.

Role & responsibilities Analytical Development Laboratory (ADL) Position: Executive Experience: 03-08 Years Qualification: M.Pharm / M.Sc Job/ Skill Set HPLC/GC/IC method development, feasibility, verification, equivalency, validation for complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC,IC, GC etc. NI/GI & NDSRI with LCMS/GCMS expertise, Solid state characterization and API sameness study Hands on experience on in-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study Welversed with USP/EP/BP/IP and various current regulatory guidelines (ICH/EMEAVFDA) Perform maintenance and calibration of lab instruments / equipment Contact Details: Email : nitinsingh@torrentpharma.com

Job Overview: As a Peptides Production Executive, you will be responsible for learning and assisting in the production of peptides according to established protocols and quality standards. This position is designed to provide hands-on training in peptide synthesis, purification, and related processes. Key Responsibilities: Understand and follow standard operating procedures (SOPs) for peptide synthesis. Assist in the preparation of reagents, solutions, and equipment for peptide production. Execute peptide synthesis under the guidance of experienced personnel Learn and perform purification techniques such as HPLC, chromatography, and filtration. Assist in maintaining accurate records of production and testing activities. Follow Good Manufacturing Practices (GMP) and safety guidelines. Learn to operate and maintain peptide production equipment. Report equipment malfunctions or abnormalities promptly. Maintain accurate and detailed records of all production activities. Compile data and assist in preparing production reports. Communicate effectively with team members and supervisors. Contribute to the identification and implementation of process improvements. Provide feedback on procedures to enhance efficiency and quality Attend training sessions to enhance knowledge and skills. Actively participate in professional development opportunities. Preferred candidate profile: Masters/Bachelors degree in Chemistry or a related field. Basic understanding of peptide synthesis principles is a plus. Strong attention to detail and commitment to quality. Ability to work in a team-oriented environment. Good communication and interpersonal skills. Willingness to learn and adapt to new processes.

Role & responsibilities Lead and manage peptide R&D Purification projects from inception to completion, ensuring timelines, budgets, and quality standards are met. Design and implement advanced purification strategies for peptide molecules Develop and implement strategic plans for peptide research and development in alignment with organizational goals and objectives. Purification of Peptide impurities by using solution & solid phase technique. Create the Innovative Research and Development Environment Train and guide the research teams to improve on developing/ adopting new chemical technologies. Drive positive & major EHS Cultural transformation Initiatives Take ownership of solvent recovery and yields improvement. Mentor and manage a team of scientists and research associates working in peptide purification. Ensure compliance with regulatory guidelines and requirements governing peptide drug development and help the teams in successful regulatory inspection with no critical observations

Lead and manage peptide R&D Purification projects from inception to completion, ensuring timelines, budgets, and quality standards are met. Design and implement advanced purification strategies for peptide molecules Develop and implement strategic plans for peptide research and development in alignment with organizational goals and objectives. Purification of Peptide impurities by using solution & solid phase technique. Create the Innovative Research and Development Environment Train and guide the research teams to improve on developing/ adopting new chemical technologies. Drive positive & major EHS Cultural transformation Initiatives Take ownership of solvent recovery and yields improvement. Mentor and manage a team of scientists and research associates working in peptide purification. Ensure compliance with regulatory guidelines and requirements governing peptide drug development and help the teams in successful regulatory inspection with no critical observations

Role & responsibilities Analytical Development Laboratory (ADL) Position: Executive Experience: 03-08 Years Qualification: M.Pharm / M.Sc Job/ Skill Set HPLC/GC/IC method development, feasibility, verification, equivalency, validation for API, complex OSD products, oncology products, topical products having exposure to regulated, Semi Regulated & India markets Comparative evaluation of methods with alternative vendor methods versus existing primary vendor and regulatory impact analysis Dissolution development, comparative dissolution, multimedia dissolution and statistical evaluation and report preparation Good understanding and hands on experience of analytical instruments like HPLC,IC, GC etc. NI/GI & NDSRI with LCMS/GCMS expertise, Solid state characterization and API sameness study Hands on experience on in-vitro Studies, E&L, Solid State characterization, IVPT/IVRT, Impurity characterization, sameness study Welversed with USP/EP/BP/IP and various current regulatory guidelines (ICH/EMEAVFDA) Pertorm maintenance and calibration of lab instruments / equipment Contact Details: Email : nitinsingh@torrentpharma.com, devalmodi@torrentpharma.com, vilshashah@torrentpharma.com

Role & responsibilities Job Description/Responsibility for 5-7 Years Experience candidate (Designation: Sr. Research Executive-SRE) Candidate must have throughout experience in Peptide process development Must be familiar with the designing of peptide drug substances route of synthesis Sound knowledge about the capping/cyclization of peptide chain Knowledge about protection and Deprotection of amino acids Knowledge about global deprotection of peptide form Peptidyl resin Must be familiar about the isolation of crude peptide Knowledge about the critical process parameters of solid phase Peptide synthesis Basic knowledge about purification techniques for crude Peptide 9.Able to handle 100 mm DAC as on required Must be familiar with peptide synthesis process scale up Job Description/Responsibility for 2-3 Years Experience candidate (Designation: Sr. Research Associate-SRA or Research Executive-RE) Candidate must have experience in Peptide process development Able to perform experiment as suggested by team leader Knowledge about protection and Deprotection of amino acids Knowledge about global deprotection of peptide form Peptidyl resin Must be familiar about the isolation of crude peptide Knowledge about the critical process parameters of solid phase Peptide synthesis Basic knowledge about purification techniques for crude Peptide Job Description/Responsibility for– 2-4 Years Experience candidate (Designation: Sr. Research Associate-SRA or Research Executive-RE) Responsible for Column packing and un-packing activity for purification trials Responsible for Column Performance Test (CPT) Peptide & API Purification method development on preparative HPLC Perform downstream-Purification of Crude Peptide on 100 mm DAC Define pooling strategy/control strategy for Purification method Preform salt exchange activity on 100 mm DAC Generate report for Design of Experiment (DoE) for Purification Co-work for solid phase up-stream synthesis Perform and optimization of global deprotection of Peptidyl resin