26 Peptides Jobs

As a Medicinal Chemistry leader at Alembic, you will be at the forefront of driving the next wave of therapeutic innovation. Your role will involve shaping the future of drug discovery from India and bridging into the U.S. biotech ecosystem. Based in Hyderabad Genome Valley, you will work full-time and report to the Head of Drug Discovery at Alembic. You will be tasked with spearheading small-molecule and peptide drug discovery efforts, shaping and executing innovative strategies that drive programs from target identification to nominating clinical candidates. Alembic is seeking a visionary and accomplished leader with a track record of advancing compounds from early discovery to IND-enabling studies. The ideal candidate will possess deep expertise in medicinal chemistry, hands-on problem-solving skills, and preferably experience in computational chemistry or AI-enabled design. Your key responsibilities will include leading medicinal chemistry strategies for designing, synthesizing, and optimizing novel drug candidates. You will execute SAR strategies to enhance potency, selectivity, and overall drug-like properties, driving hit-to-lead and lead optimization efforts across multiple discovery programs. Additionally, you will incorporate AI-driven drug design and computational modeling into the medicinal chemistry workflow and manage external collaborations with CROs and academic partners. Furthermore, you will partner closely with various teams such as biology, pharmacology, DMPK, and analytical chemistry to integrate data and advance candidates efficiently. Your role will also involve analyzing experimental results, generating hypotheses, and making data-driven decisions to guide programs. Building and mentoring a team of medicinal chemists to foster scientific innovation and professional growth will also be a part of your responsibilities. To qualify for this role, you should hold a PhD in Organic or Medicinal Chemistry (or a related discipline) with over 10 years of industry experience in drug discovery. Demonstrated leadership in advancing small molecules or peptides into the clinic, deep expertise in synthetic chemistry, drug design, and SAR optimization are essential. Exposure to AI-based drug discovery, computational chemistry, or fragment-based design will be advantageous. Strong communication, leadership, and decision-making skills are also required. By joining Alembic, you will lead cutting-edge medicinal chemistry initiatives, collaborate with world-class scientists in an innovation-driven culture, play a central role in shaping Alembic's emerging therapeutic pipeline, and contribute to an organization committed to scientific rigor, global impact, and patient health. Alembic embraces diversity and is dedicated to building an inclusive team.,

Location: TruPeak Health, Dadar (Mumbai) Type: Full-time | On-site Industry: Precision Healthcare | Longevity & Functional Medicine | Corporate Wellness About TruPeak TruPeak Health isnt just another wellness brand; we are a science-first transformation centre redefining vitality, aesthetics, cancer nutrition, and longevity through advanced diagnostics, precision protocols, and regenerative therapies. Our verticals span from hormone therapy and immune profiling to medical aesthetics and corporate metabolic reset programs. As Indias first truly integrated functional medicine ecosystem, we are on a mission to scale personalised care thats rooted in data, biology, and innovation. Role Overview We are looking for a high-performance Marketing Executive Corporate Sales & Partnerships to drive B2B growth through outreach, wellness tie-ups, institutional partnerships, and campaign activations. You will act as the face of TruPeaks corporate wellness and enterprise solutions, crafting go-to-market strategies, pitching health transformation programs to HR heads and CXOs, and growing the brands footprint across urban India. Key Responsibilities Identify, pitch, and close partnerships with corporates, luxury housing societies, gyms, hotels, and wellness aggregators Drive corporate sales for programs like VO2 Max testing, Metabolic Health Reset, Executive Wellness Panels, and Longevity Diagnostics Build and manage lead pipelines via outbound, LinkedIn, and strategic networking Plan and execute corporate activation events (talks, drips, demo days, workshops) Collaborate with internal teams (doctors, operations, content) for aligned outreach Create monthly growth and performance reports, including ROI on campaigns Support strategic collaborations with health-tech platforms, labs, and fitness aggregators Requirements 46 years experience in marketing, business development, or strategic partnerships (healthcare, diagnostics, med-spa, fitness, or insurance domain preferred) Proven success in B2B sales, wellness tie-ups, or corporate partnerships Strong communication and pitch skills, both written and verbal Professional presence, high EQ, and client-first approach Familiarity with CRM tools, LinkedIn Sales Navigator, or outbound email automation Interest in precision health, wellness, and new-age medicine (knowledge of terms like VO2 Max, Q-NRG, gut testing, peptides is a plus) What Youll Gain Opportunity to work with Indias most advanced functional medicine centre Access to doctors, experts, and proprietary testing tools like MuscleSound, Q-NRG, and InBody970 High-impact role with visibility across CXO decision-makers in health, insurance, and corporate wellness Fast-track growth into a Manager or Head Partnerships & Strategy role A mission-driven culture that values science, empathy, and innovation How to Apply Send your CV + short intro note to: ???? [HIDDEN TEXT] ???? Location: TruPeak Health, Dadar (Mumbai) TruPeak Health Transform into a New YOU. Corporate Wellness | Regenerative Longevity | Peak Performance Medicine Show more Show less

You will be working as a Scientist specializing in Peptide Chemistry. Your role will involve synthesizing and characterizing peptides, planning and executing their synthesis with the required purity and quantity, troubleshooting any issues, and ensuring compliance with IPM and Safety norms. Additionally, you will be responsible for developing methods for functionalized peptides and preparing key intermediates through solution phase synthesis for the synthesis of final target molecules. Your main responsibilities will include: - Synthesizing and characterizing peptides to meet project requirements. - Developing troubleshooting skills and adhering to IPM and Safety norms. - Creating methods for special functionalized peptides. - Preparing key intermediates through solution phase synthesis for the synthesis of final target molecules in order to successfully synthesize and deliver target compounds as per project specifications. You will also be required to interpret analytical data to identify synthesized targets and key intermediates for successful characterization. Furthermore, you must strictly adhere to lab safety and industrial hygiene practices to ensure safety compliance.,

Only for male candidates We are hairing for Chemists/Sr.Chemists/Manager/Ass.Manager 02 to 15 yrs(peptides) R&D CDMO:Sr.Executive/Executive(05 to 8 yrs) Roles and Responsibilitie Develop peptide-based products from concept to commercialization, ensuring compliance with regulatory requirements. Design, optimize, and scale up peptide synthesis processes using various techniques such as solid phase synthesis, solution phase synthesis, and enzymatic synthesis. Ensure timely delivery of high-quality products that meet customer expectations. Conduct research on new technologies and methodologies to improve productivity, efficiency, and quality of peptide production.

* Process development, scale up and technology transfer of products from R&D to Pilot plant upto commercial batches to production department as per regulatory requirement * Day to day lab experiment planning & to ensure execution Required Candidate profile * To ensure requirement of raw materials as per experiment planned in R&D and pilot plant. *Complete literature search with IPR status study, ROS finalization, lab experiment planning.

* Implement and manage production processes for injectable DPI and liquid injection product. * Ensure all operations comply with GMP and regulatory requirements. * Prepare daily reports and update process documentation consistently Required Candidate profile * Knowledge of Peptide synthesis, Purification & Lyophilization operation. * Operation of reactor, Nutsche filter, centrifuge * Handling experience of equipment Lyophilizer and Autoclave

Long Description 1. Perform characterization of peptides , nucleic acids-based (oligonucleotides) or other injectable drug products using High Resolution Mass Spectrometry (LC-HRMS) . Experience with QToF/Orbitrap instruments and Ion Mobility will be preferred. Additional experience in Fluorescence, particle size analysis (DLS), and other relevant techniques (e.g. SEC-MALS) are desirable. 2. Analyze and interpret LC-MS and MS/MS data for impurity profiling and characterization. Solve problems and implement new research methods through literature search, coordinate with cross-functional teams (formulation, QA, QC, regulatory, etc.), application specialists, etc. to complete analytical tasks. 3. Prepare, review and share LC-MS data and documentation (SOP, STP, Test Reports, etc.) in a timely manner for regulatory submissions. Follow good laboratory practices (GLP) , manage samples (collection, storage, and disposal), deviations and incidences as per established procedures. 4. Undertake routine maintenance & calibration of the analytical instruments, troubleshoot equipment malfunction often in coordination with service engineers, etc. Assist in the maintenance of the laboratory, inventory of R&D consumables, & other lab management activities from time to time Competencies Education Masters in Pharmacy or Applied Chemistry Doctorate in Pharmaceutical Technology or Analytical Chemistry Work Experience 5 – 7 years (with MPharm) or NIL (with PhD)

Roles and Responsibilities ONLY FOR MALE CANDIDATES Prepare and review batch records for API production runs. Collaborate with cross-functional teams to resolve issues related to product development and manufacturing. Maintain accurate records of test results, inventory management, and equipment maintenance.

We are seeking to hire an innovative and highly motivated Formulation Scientist to join our Biologics RD team . The qualified individual will have at least 3-5 years of relevant industry working experience in developing parenteral formulation, solid and liquid oral dosage forms for use in first-in-human studies. The Formulation Scientist in the Large Molecule Drug Product Development will be a lab-based role, responsible for experimental studies in the pre-formulation, formulation, characterization, and analytical development of therapeutic proteins including monoclonal antibodies, virus-like particles, RNA therapeutics, and subunit-based vaccines. Since most of our clients are based out of USA and Europe, we expect candidates to have some exposure working on international projects. Major Duties and Responsibilities: Develop formulations for parenteral/ injectable and oral drug products. Develop parenteral formulations for biotherapeutic modalities such as monoclonal antibodies, antibody-drug conjugates, proteins, and vaccines. Perform rapid, comprehensive characterization of candidate molecules to determine the stability profile and apply this information to develop an appropriate dosage form to meet clinical needs. This will be achieved by applying various biophysical and biochemical techniques such as HPLC (SE-HPLC, IEX, RP-HPLC), SDS-PAGE, Capillary Gel electrophoresis (CGE), and imaged Capillary Electrophoresis (iCE). Evaluates feasibility of analytical methods to support product characterization, formulation stability, and compatibility testing. Rational formulation design/selection and characterization studies relevant to the stage of development. Development and optimization of liquid and lyophilized biologics formulations. Design and execute compatibility studies to support the administration of large molecules Design and manage stability studies on target and experimental formulations Perform her/his duties consistent with good laboratory practices Preferred qualifications: Knowledge of protein science, including biochemical, immunological, and biophysical characterization. Knowledge and experience in the development of large molecule formulation. Familiarity with biochemical, biophysical, and/or analytical methodologies for characterization of proteins and peptides. Hands-on experience and trouble-shooting proficiency with column chromatography (SEC, IEX, RP, HIC), biophysical characterization (DLS, DSC, DSF, fluorescence, EM), capillary electrophoresis (CE-SDS, cIEF, iCE), charge variant analysis, oxidation analysis, and peptide mapping for protein characterization are highly desirable. Required qualifications: Ph.D. + > 3 years experience, M.S. + > 5 years experience, or B.S. + > 8 years experience in an appropriate scientific discipline is required. Strong scientific understanding and extensive research experience is necessary. Experiences in the areas of formulation/drug product development, biophysical/biochemical characterization, analytical method development for mAb or recombinant protein-based biotherapeutics and pharmaceutical development are desirable Ability to interpret and analyze data from biophysical assays and design appropriate experiments. Demonstrated experience delivering high quality and timely data while adhering to compliance and data integrity requirements Self-motivated, attention to details, excellent teamwork, organization, oral/written communication skills are highly desirable

Job Title: Research Associate Department/Function: BRL Reporting To: DGM Location: HO @ Govandi, Mumbai Working Days: 5 days from Office + Alternate Saturdays - 1st, 3rd & 5th Working Job Summary: Will work in Analytical development Lab of BRL. Responsible for analytical deliverables of Biologics Projects for all markets. Deliverables involves, but not limited to Method Development, Qualification, Technology transfer, Biosimilarity assessment, Forced degradation and Characterization activities. Responsible for independent planning and execution of experiments. Techniques include, but not limited to Chromatography, Electrophoresis, Spectrophotometric-Colorimetric assays and Higher order characterization for Biotherapeutics. Required Skillsets: Knowledge and hands-on experience of different chromatography modes like RP, HIC, IEX, SEC, etc is required. Preferred to have some working knowledge of biosimilars. The following are considered strong assets: Manufacturing industry experience, JAVA stacks experience. Maintain effective and cooperative working relationships with administrators, staff, users, project consultants. Good to have : Integration with Non SAP systems via RestAPI, SOAP API , SFTP etc. Experience Required: Experience of working on biotherapeutic proteins like Cytokines, Fc fusion peptides/proteins and/or Monoclonal antibodies is required Method Development and/or routine analytical support experience with biosimilars is a must Understanding of analytical deliverables involving CQA, QTPP, Biosimilarity, Forced degradation studies, Specifications setting, etc. is preferred. Accountability: To perform assigned analytical activities by following established systems and procedures. To maintain target dates for analytical activities. To maintain data integrity during analysis. Preparation and review of reports and contribution in troubleshooting efforts required for Instrumentation Communicate effectively with other team members and teams regarding the analytical data. Education: Min. Qualification Required - M.Sc. / M.Tech. - Biotechnology / Microbiology Experience: Minimum 6 months- 2 years

BD & provide technical support. Handle Multistep Synthesis. Peptides Synthesis using Solid Phase Peptide Synthesis. Design & synthesis of small molecules in API. Handling synthesis of organic chemical reactions.Knowledge on Instrumentation is a must. Annual bonus Provident fund Health insurance

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. Roles & 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 opportunitie Experience 4 to 6 Yrs experience in Peptides Manufacturing Preferred candidate profile: 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.

Alembic Pharmaceuticals Limited is looking Sr. Research Scientist or Team Leader for Complex Injectable (Formulation & Development) based at our Injectable R&D Vadodara. Role & Responsibilities : Demonstrate expertise in drug device combination product (pen injector/auto injector/PFS) development device suitability, functionality testing as per ISO standards and comparative threshold analyses etc. Hands on experience in Peptide based injectable product development & peptide characterization to prove the sameness. Good understanding of Immunogenicity concept & bioassay for peptide. Proficient in technology transfer of device based products, Suspension products , terminally sterilized and lyophilized products bottleneck/gap identification & trouble shooting Good understanding of intellectual property with focus towards developing a non-infringing strategy for patent claims and develop a Para IV strategy for first to file products Able to evaluate and design the strategy for 505 (b) (2) products proof of concept studies and regulatory requirements Having sound understanding for regulatory query response Have good experience in - briefing book preparation, biowaiver control correspondence and Pre-ANDA meeting Understanding of QbD applicability and Statistical tool in Product development to ensure built in quality Hands on expertise in Designing & monitoring product development strategies - Literature, Patent landscape, Sourcing, Pre-formulation, Prototype development, Formulation & Process Optimization etc. Interested Candidates may share their CV to msnt@alembic.co.in with position title : "SRS or Team Leader-Injectable".

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. Experience Min 1 Year experience in Peptides manufacturing Competencies 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. Responsibilities Qualifications Masters/Bachelors degree in Chemistry or a related field.

Job Description 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. Experience: Min 2 to 3 Yrs experience in Peptides production department. Preferred candidate profile: 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. Responsibilities Qualifications Masters/Bachelors degree in Chemistry or a related field.

Role and Responsibilities Do literature search for a given step(s) / molecules and support in LSR Organize for relevant patents and papers from literature Developing, synthesizing, and analyzing peptides using various techniques like Solid & Liquid Phase Peptide Synthesis (SPPS), LC-MS, and NMR Researcher will be responsible for characterizing peptides, ensuring quality control, and contributing to research projects by designing experiments and analyzing data Developing and executing synthetic strategies for complex molecules. Purifying and analyzing synthesized peptides to assess sequence and purity. Understanding and applying principles of peptide chemistry, including the use of protecting groups and coupling agents Acquiring and interpreting data from analytical techniques like HPLC, LC-MS, and MALDI-TOF. Using spectroscopic techniques to analyze and identify compounds. Maintaining accurate records and reports of analytical data Adhering to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). Maintaining a clean and organized laboratory environment. Competencies required Sound knowledge of Organic Chemistry & Spectroscopy ICH Guidelines and basic IP understanding Good experimental hand & Scale-up knowledge Critical Thinking & excellent observance Problem Solving Ability Excellent teamwork and collaboration within & with other functions Good communication Qualifications, Education and skill Requirements M.Sc. Organic Chemistry with 3-5 years industrial experience Ph.D. Chemistry with 12-year Industrial experience Interested candidate can share their profile on jasleen.kaur@tapi.com or connect on 8076954558.

Alembic pharmaceutical is looking for suitable professional for the position of Executive / Senior Executive - Peptide Production for our API site based near Vadodara. Job Criteria : B.Tech / M.sc Minimum 1 to 6 years of relevant experience working on peptide production. Good communication skills. Role & responsibilities Handling of peptide products, and knowledge on handling peptide products in GMP environment. Handling of Peptide Synthesis, both solid phase and solution phase. Handling of RP-HPLC Column 50 mmid, 110 mmid, 200 mmid, 300 mmid, 450 mmid , 800 mmid. Handling of Ion exchange chromatography. Handling of lyophilizer, Nano filtration system, TFF system. Handling of long chain to short chain peptides. Prepare the area/section for batch production as per QA guidelines. Supervise equipment operation in assigned production area and maintain critical process parameters as mentioned in Batch Manufacturing Record (BMR). Ensure personal protective equipment are worn by all employees and safety parameters are observed by plant operators and discipline is maintained. Coordinate with service departments for meeting the requirement(s) of the plant. Intimate Quality Control department for in process analysis as per production plan. Perks and benefits Best in Industry

Role & responsibilities 1. Candidate should be B-tech (chemical) preferably. 2. Candidate should have minimum 3 to 10 years work experience in Peptide R & D, PD, MS & T, Tech transfer. 3. Candidate should have work experience on peptide SPPS/LPPS upstream (Synthesis) and Downstream (Purification) process. 4. Candidate should have hands on SPPS peptide synthesizer, Preparative HPLC, Column packing/ unpacking, HETP, Lyophilizer etc. 5. Candidate should have involves with R & D team for what if studies / to identify process requirements and to ensure the process can be execute smoothly at manufacturing scale. 6. Candidate should enough competent for technology adsorption, scale up and validation support for the peptide API. 7. Candidate should have able to Monitoring peptide upstream and downstream process and ability to demonstrate to operators. 8. Candidate is responsible Ensure we make scalable, robust and competitive peptide APIs. 9. Support the CFTs with continuous process and projects improvement, implementation of new technologies and products, scale-up and troubleshooting. 10. Responsible to prepare/review technical documents and other allied activities. 11. Train and support team adequately to accomplish the day to day tasks. 12. Ensure self and team members safety at all time. Coordinate with CFTs to meet the same. 13. Any other relevant activities assigned by reporting manager to be taken up on priority basis. 14. Operation of softwares like SAP, LIMS, WMS, GxP Digitize and Documentum as per applicability

Alembic Pharmaceuticals Ltd. is looking for Research Scientist/ Senior Research Scientist- Analytical Development Advanced characterization Laboratory (Peptides and Complex Generics) based at our Injectable R&D Vadodara Role & responsibilities : 1) Develop and validate analytical methods for various aspects of peptide and complex injectable formulations, including purity, identity, degradation products and stability. 2) Expertise in relevant techniques like HPLC, LC-MS, UV/Vis Spectrophotometry, GC, Particle size, In vitro release etc. 3) Data analysis and interpretation, prepare analytical protocols, reports and contribute to regulatory submissions. 4) Identify and resolve analytical issues, ensuring method accuracy and reliability. 5) Ensuring compliance with cGMP and GLP. 6) Exposure of characterization study for peptide and complex injectable formulation as per product specific regulatory guidelines. Interested Candidates may share their CV to msnt@alembic.co.in with position title "ARD"

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.