18 Monoclonal Antibodies Jobs

You will be responsible for leading the Cell & Molecular Biology department. Your tasks will include designing and executing recombinant antigen generation in E.Coli, Insect, and mammalian cells for diagnostic kits. You will also be generating monoclonal antibodies against antigens using Hybridoma / Phage display methods. Additionally, your role will involve making recombinant antibodies by isolating genes from Hybridoma and expressing them in Mammalian cells. To qualify for this position, you should have an M.Sc or PhD in Life Sciences with at least 10-15 years of experience in Recombinant proteins and Monoclonal Antibody generation. You are expected to have expertise in Molecular Biology, Cell culture, and Purification. Knowledge about diagnostic assays such as CLIA, Rapid, and ELISA would be considered an added advantage.,

The Executive in Downstream Manufacturing department located in Bengaluru, India is expected to actively participate in the day-to-day activities of downstream processes. You will provide technical leadership to junior staff involved in downstream process activities. It is essential to be well-versed in AKTA Process systems and assist supervisors during critical activities such as tech transfer and scale-up. A minimum of 4-6 years of experience in downstream processing of Monoclonal Antibodies or Recombinant Therapeutic Proteins is required, along with educational qualifications of BTech/MTech/MSc. Additionally, experience in the scale-up of purification processes is preferred.,

As a Production Associate at Piramal Pharma Solutions (PPS), you will be part of a dynamic team within a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end solutions across the drug life cycle. Your role will involve contributing to the development and manufacturing processes to ensure the delivery of high-quality pharmaceutical products. In this position, you will work at Piramal Enterprises Limited, located at Plot # 67-70, Sector II, Dhar, Madhya Pradesh, 454775, IN. As a full-time employee, you will be expected to adhere to the job schedule and actively participate in the production activities. The Piramal Group, with a strong foundation of inclusive growth and ethical practices, values equal employment opportunities. Employment decisions are based on merit, taking into consideration qualifications, skills, performance, and achievements. As an organization, we strive to provide equal opportunities to all applicants and employees in various personnel matters, ensuring fairness in recruitment, training, promotion, compensation, and working conditions. PPS offers a wide range of services including drug discovery solutions, process development, clinical trial supplies, commercial API manufacturing, and finished dosage forms. Additionally, specialized services such as highly potent APIs, sterile fill/finish, and biologics manufacturing are also provided. With a global network of facilities, PPS has established itself as a trusted partner for innovators and generic companies worldwide. Join us at Piramal Pharma Solutions and be part of a team that is committed to excellence, innovation, and growth in the pharmaceutical industry.,

Job Description: As an Executive or Senior Executive at Syngene, you will be responsible for method development, validation, and stability testing of drug substance/drug product. Your primary role will involve having strong hands-on experience in developing and validating Assay & related substances methods for drug substance/drug product. Additionally, you will be expected to work with complex injectables and be willing to work in shifts. Your core responsibilities will include handling instruments such as HPLC, UPLC, GC, UV Visible spectrophotometer, balances, Potentiometer, and stability chambers. You must be well-versed in Good documentation/laboratory practices like ALCOA+ and have experience in calibration and qualification of laboratory instruments. Furthermore, you will be accountable for preparing and reviewing raw data sheets, instrument operating procedures, and standard operating procedures. In this role, you will also be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares required for projects. Adherence to GxP/Safety procedures and internal standard operation procedures is crucial. Proficiency in operating MS Office tools and effective communication skills are essential for interactions with clients and external users. To excel in this position, you should possess good interpersonal skills, self-time management abilities, and be a strong team player. The role also requires polite and effective communication skills. Syngene Values: At Syngene, we uphold the values of Excellence, Integrity, and Professionalism, and as a team member, you are expected to consistently demonstrate alignment with these core values. Specific Requirements: - Experience: 3-6 years - Skills And Capabilities: Hands-on experience in HPLC, UPLC/UHPLC, GC, UV-Visible spectrophotometer, Potentiometer, and other analytical instruments. Knowledge of good documentation/laboratory practices such as ALCOA+ is required. Experience in particle size determination, Zeta potential, and particulate matter analysis techniques will be advantageous. Familiarity with SEC, CGE methods for mAbs is a plus. Proficiency in MS Office tools is necessary. - Education: M. Pharm /M. Sc with 3-6 years" experience in R&D under GMP environment (QC) If you meet the requirements mentioned above and are looking to contribute to a culture of safety, innovation, and excellence, we invite you to apply for this exciting opportunity at Syngene.,

Lead Cell & Molecular Biology department. Design and execute recombinant antigen generation in E.Coli, Insect and mammalian cells for diagnostic kits. Generate monoclonal antibodies against antigens by Hybridoma / Phage display methods. Making recombinant antibodies Isolate genes from Hybridoma and expressing them in Mammalian cells. Preferred candidate profile Handson experience in Recombinant proteins and Monoclonal Antibody generation. Expertise in Molecular Biology, Cell culture and Purification. Knowledge about diagnostics assays CLIA, Rapid and ELISA would be an added advantage.

Job Description: You will be joining a renowned organization, Piramal Group, which has been thriving for three decades through a strategic approach of both organic and inorganic growth. At Piramal Group, we are committed to inclusive growth driven by our core values, ensuring that ethical and values-driven practices are at the forefront of all our endeavors. Equal employment opportunity is a cornerstone of our work culture. All employment decisions are based on merit, taking into account qualifications, skills, performance, and achievements. We are dedicated to providing equal opportunities to all applicants and employees in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions. We also offer reasonable accommodation for qualified individuals with disabilities and those with specific needs related to their religious observance or practice. Join the team at Piramal Pharma Solutions (PPS), a Contract Development and Manufacturing Organization (CDMO) that provides comprehensive solutions throughout the drug life cycle. Our globally integrated network of facilities in North America, Europe, and Asia enables us to offer a wide range of services, including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. Additionally, we specialize in the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also caters to the development and manufacturing services for biologics such as vaccines, gene therapies, and monoclonal antibodies, facilitated by Piramal Pharma Limited's investment in Yapan Bio Private Limited. With a proven track record as a trusted service provider across various technologies, we are the preferred partner for innovators and generic companies globally. Job Info: - Job Identification: 9041 - Job Category: Supply Chain - Posting Date: 07/15/2025, 03:58 PM - Apply Before: 07/26/2025, 03:57 PM - Degree Level: Bachelor's Degree - Job Schedule: Full time - Location: Piramal Enterprises Limited. Factory: Digwal, Medak, Telangana, 502321, IN,

Job Location: Pune Qualification: Ph.D (Biochemistry/Molecular Biology/Pharmacology/Biotechnology) Drug Discovery (mAbs, Preclinical) Position Summary: We are seeking a highly motivated and experienced Scientist/Senior Scientist to join our Drug Discovery team focused on monoclonal antibody (mAb)-based therapeutics. The successful candidate will play a key role in the early-stage discovery and preclinical development of biologics, supporting programs from target validation through candidate selection. This position requires a strong background in biologics discovery, preclinical development, and experience collaborating with CROs to drive project deliverables. Key Responsibilities: Lead or contribute to discovery-stage biologics programs with a focus on mAb development. Design and execute in vitro and in vivo studies for target validation, mechanism of action, and lead optimization. Drive preclinical discovery efforts, including selection and characterization of lead mAbs. Collaborate with cross-functional teams (e.g., biology, protein engineering, pharmacology) to ensure seamless progression of pipeline candidates. Manage CROs to support assay development, in-vitro and in-vivo experience. Interpret, analyze, and present experimental results to internal teams and stakeholders. Contribute to regulatory documentation and IND-enabling study design. Required Qualifications: PhD in Biological Sciences, with 5-8+ years of experience in biologics drug discovery. Proven track record in discovery and preclinical development of monoclonal antibodies or other biologics. Hands-on experience with in vitro assays (e.g., binding, functional screening, flow cytometry). Strong understanding of preclinical discovery workflows and biologics development pipelines. Demonstrated experience working with or managing CROs. Excellent communication, organizational, and data analysis skills.

Role & responsibilities Lead the upstream process group to design and develop cell culture processes for monoclonal antibody and fusion protein production. Provide expert leadership overseeing both strategic and day-to-day activities in upstream process development of complex novel biologics. Oversee technology transfer to support scale-up and GMP manufacturing. Build strong relationships with CMOs, to optimize efficiency, productivity, quality and supply assurance. Design and execute risk-based process characterization studies to define critical process parameters (CPPs) and critical quality attributes (CQAs). Employ DOE and QbD principles for process optimization and robustness assessment. Scale-up process from laboratory-scale bioreactors to pilot and commercial-scale, ensuring process robustness and consistency in compliance with regulatory requirement. Prepare technology transfer protocols/descriptions and execute transfer to clinical and commercial manufacturing sites. Collaborate with downstream processing, analytical development, and quality assurance teams to ensure seamless integration of upstream processes. Liaise with regulatory affairs to ensure compliance with industry standards and guidelines. Analyze experimental data to draw meaningful conclusions and make data-driven decisions. Prepare and present technical reports, project updates, and scientific findings to senior management and stakeholders. Ensure that all upstream processes are compliant with cGMP, ICH, FDA, EMEA regulatory requirements. Prepare and review process descriptions and CMC sections of regulatory documents to support regulatory submissions as required for IND and BLA. Develop and implement strategic plans to achieve project milestones and goals. Mentor and develop team members to foster a high-performance culture.

Role & responsibilities Role-specific: Perform all the Downstream activities like Assembly preparation, accessories arrangement for step, Dispensing of raw materials and consumables, Reconciliation of excess and unused raw materials and consumables Buffer Preparation, Harvest Clarification, Chromatography operation, Low pH and Intermediate depth filtration, Viral filtration, TFF Operation and 0.2 filtration. Operating and cleaning of downstream equipment(s) as per standard operating procedures and EOP. Monitoring and process control of the specific Operations of the Downstream. Maintenance of Quality records. Perform In-process product sampling, sample submission and storage. Preparation and review of operation related documents. Perform room owner responsibility for the assigned DSP area. Perform equipment/instrument ownership related responsibilities related to DSP. Initiate Complaint Slips (work orders) for DSP related areas and equipment. Coordinate with QA for line clearance. Maintaining process area All-time ready for Inspection/ audit purpose. Maintain facility and assigned zone all-time ready for visit and audit. Involve and support in execution of batches as and when required and perform error free operation as per Batch Manufacturing Record (BMR). Involve in shipment of samples / final product as per packing and dispatch record. Work proactively to meet all document(s) on time closure requirement. Preparation of general Downstream related procedures, protocols, risk assessment and BMRs. Execute the protocols related to Downstream related activity and equipment / instrument qualification. Involve in Shipment of amples /final product as per packing and dispatch record. Preparation and periodic revision of equipment cleaning checklist (ECC)as ad when required. Execute the batch activity as per BMR and report nonconformity to the supervisor. Review of executed Documents on time. Issuance of annexures, RM, consumables and BMRs. Track the work order status and ensuring timely closure. Involve in Downstream related activities under supervision of Downstream supervisor. Education Masters degree/ bachelors degree in pharmacy, Masters degree in Pharmaceutical Sciences. Industry Experience Minimum 2 years of relevant practical experience in mAbs downstream process.

Sales of Filtration Products from leading Filtration brands in Pharmaceuticals (API & Formulation), Biopharma (Mabs, Vaccines, Other Biosimilars), Oil & Gas industries, Ultrapure Water, Digital Inks & Printers Visiting Industrial across the assigned region for pitching High Performance Industrial products for various applications. The candidate will undergo training and will be meeting key decision makers in the industry and do value selling. Candidate will hold Technical/Commercial discussions with R&D, Manufacturing, Production providing them product benefits, commercial offers, negotiations, order execution followed by payment collection. The candidate will adhere to the visit plans & provide regular visit report to Manager. Candidate will be empowered with data for Sales forecasting Monthly, Quarterly and Annually based on sales history and new developments. All new developments will be uploaded in Sales Funnel for Customer mapping and keeping Track of competitors activities in the region. Candidate will partner with the Sales Manager to meet and exceed sales targets and developing new accounts to grow the business. Role & responsibilities Preferred candidate profile

Core Purpose of the Role: Responsible to perform the development, validation, and routine testing of bioassay/ELISA for Large Molecules (LMs), especially Monoclonal antibodies (mAbs) and other LMs Role Accountabilities: Shall develop and validate cell-based assays and binding assays (ELISA), especially for monoclonal antibodies (mAbs), etc. Shall troubleshoot the problems with bioassay methods Must have strong knowledge of the development of cell-based bioassays for Monoclonal antibodies. Experience in Qualification and Validation of cell-based bioassays Broad knowledge on analysis of cell-based assays to derive relative potency softwares (such as Softmax Pro and PLA) Basic cell culture technics and hands-on experience in maintaining of mammalian cells. Must have experience in handling various cell lines (adherent and suspension cell lines). Preparation of Mammalian cell banks for Bioassays. Experience in handling of primary and continuous cell lines like Revival, maintenance, cell bank preparation, and cryopreservation Shall prepare the raw datasheets, protocols, reports, and SOPs Handling of QMS (Incidents, deviations, change controls, etc.) for GMP activities Shall be responsible for procurement and inventory maintenance of Pharmacopeial Standards/Chemicals/Reagents/Consumables/Spares etc., required for the projects Shall adhere to the procedure of GxP/GMP/Safety and as per the procedure defined in the internal standard operation procedure Must have good hold on MS office (word, excel, ppt), outlook, and other essential tools required for routine activity Good communication and e-mail writing skills are required since the candidate needs t communicate with clients/external users situated overseas Commitment to safety

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Good team player. Good written and oral communication Role & responsibilities Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

Role & responsibilities : 1. Monoclonal antibody generation by Hybridoma and Phage display 2. Making recombinant monoclonal antibodies from Hybridoma 3. To perform immunization of Mice & Rabbit. 4. Fusion of Myeloma and spleen cells 5. Screening by ELISA and any other methods 6. Regular documentation. 7. Managing Resources Preferred candidate profile Expertise in cell culture and monoclonal antibody development by hybridoma and modern techniques.

Technical/functional skills: 1. Development, performance and troubleshooting of cell-based assays development, qualification and sample analysis for therapeutic protein, monoclonal antibodies. 2. Development, performance and troubleshooting of SPR, ELISA and flow cytometry assays for monoclonal antibodies. 3. Preparation of technical documents. 4. Writing of SOP, Protocol and Reports. Key responsibilities : 1. Cell based assays development, qualification and sample analysis for therapeutic proteins, monoclonal antibodies. 2. To take charge of the equipment/instruments in the lab and ensure their proper functioning. 3. To support and maintain inventory of reagents & consumables required for general lab activities.

Designation Research Associate/ Senior Research Associate Department Process Development Experience 5+Years Location Bangalore Education qualification : MSc in Biotech, MSc Biochemistry / M.tech in Biotech Responsibility brief: Planning and Execution of downstream process activities as per design at downstream process development department with necessary documentation and with required and defined level of compliance Responsibilities: Planning and Execution of downstream process development activities as per the design and documentation of all the downstream processing activities. Also, ensure proper and safe archival of downstream process related documents. Preparation of reports and document preparation such as BMR, SPR, and SOP. Co-ordination with QC for sample analysis which includes sample submission and receiving the results and co-ordination with QA for the issuance of batch records and other DQA documents. Also, co-ordination with other teams such as Upstream, Analytical, Engineering and SCM for cross functional activities. Data review and management. Ensure smooth functioning of all the equipment in the downstream processing area which includes an oversight on the documentation of equipment related activities and tracking the calibration/preventive maintenance schedule. Training and development of self on the operation of equipment, downstream processing concepts, and new technologies in the field of purification etc., and attend all the relevant trainings. Ensure safety of self and personnel in the Downstream PD lab. Additional responsibilities: 1. Coordination with Manufacturing for cross functional activities. 2. Support downstream manufacturing activities based on requirement.

Good knowledge and understanding of proteins. Sound knowledge on Good laboratory practices. Hands-on experience on LC based analysis/developments for recombinant protein (mAbs/Biosimilars) required Should have sound knowledge of ICH/USP/EP/IP guidelines, including the writing and review of developmental protocols and reports. Will be part of ADL- The team works on- new method developments, qualifications, process development quality analysis, R&D stabilities Will carry out LC based developments for various quality evaluations of recombinant proteins (Example- RP, IEX, Glycans) Will carry out CE based developments for various quality evaluations Will carry out various analysis for supporting different process stages from clone selection to upstream and downstream process optimizations. Will be responsible for carrying out method qualifications and transfers either to manufacturing quality control or any outsourced labs Will plan/ carryout stability studies for R&D batches. Should be able to assess stability trends and draw conclusions Should be able to plan out experiments and activities for day-to-day functioning Will be responsible Co-ordinate with external labs for outsourced activities Maintenance of equipment logs and documentation in the lab. Will be responsible for routine experimental data compilations and reviews

Job Description (Head R&D) 1) To build and direct a team for the development of processes for the commercial manufacture of plasma derived therapeutic proteins. The responsibilities will include the following; a) Identification of plasma derived products that can be developed for commercialisation. b) Review of published literature including patents to understand the existing product, process and formulation. c) Plan the development of scalable processes for the purification and formulation of proteins from human blood plasma. d) Plan for process validation, packaging material development, stability studies, alternate vendor development studies. e) Coordinate training, scale-up and technology transfer to production including trouble shooting for Production batches. f) To continue to evaluate the processes for improved yield and purity, incorporating the latest technologies so as to be able to deliver products that are in line with global quality standards. 2) To build and direct a team for the Analytical development of pharmacopoeial & in-house test methods for products developed by the process development team. The responsibilities will include the following; a) Identification of compendial methods for quality testing of plasma derived therapeutic products, human plasma bags received from blood banks, microbiological tests and chemical tests for raw materials/packaging materials. b) To develop in-house methods where suitable compendial methods are not available. c) To validate all test methods as per ICH guidelines d) To coordinate training and transfer of test methods to QC departments for routine batch testing and release. e) To continue to evaluate the methods and incorporate the latest test methods in accordance with the pharmacopoeial revisions to deliver good and safe quality products to the market. 3) To plan and direct a team for preparation, review and transfer of documents to QA and concerned departments. The documents will include the following; a) Process development reports (PDRs) for all products taken up in Process R&D b) Technology Transfer Dossier (TTD) for process / method to Production / QC c) Master Manufacturing Process & Formula d) Process Validation Reports e) Cleaning Validation Reports f) Analytical Method development/ qualification reports and STPs g) Technical documents for Regulatory submissions to Drug Offices and Product registrations for export to other countries.

Greetings from Kashiv Biosciences!!! We are looking for Upstream Process Specialist for our Biosimilar manufacturing facility based out of Ahmedabad. Following are the Roles and Responsibilities Roles & Responsibilities Responsible for Upstream Process for Microbial Cell culture and Mammalian Cell culture. Should have exposure on various F ermentation techniques. Qualification and validation of equipment. Exposure to Perfusion process and technique is must. Candidate Details The candidate should have worked in Biosimilars Upstream production(Microbial/ Mammalian Culture) Exposure to Regulatory Audit is Must. Should be aware of QMS Documentation. The candidate should have good communication skills. Interested candidates Please share the resumes at my manan.hathi@Kashivindia.com