6 Complex Injectables Jobs

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".

Role & responsibilities Position Summary: As an Analytical Scientist at Off Targets Research, you will play a crucial role in the development and validation of analytical methods for the characterization of pharmaceutical products. You will work closely with cross-functional teams to support the research, development, and manufacturing processes by providing accurate and reliable analytical data. Key Responsibilities: Develop, validate, and optimize analytical methods for the analysis of pharmaceutical compounds using techniques such as HPLC, GC, and spectroscopy. Perform routine and non-routine analysis of raw materials, intermediates, and final products to ensure compliance with regulatory standards. Collaborate with R&D, Quality Control, and Manufacturing teams to troubleshoot and resolve analytical challenges. Prepare and review technical reports, method validation protocols, and standard operating procedures (SOPs). Maintain and calibrate analytical instruments, ensuring they are in proper working order. Interpret and present analytical data to support decision-making processes. Stay current with industry trends and advancements in analytical techniques. Preferred candidate profile Bachelor's or Master's degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field. A Ph.D. is preferred. Proven experience in analytical method development and validation, preferably in the pharmaceutical or biotechnology industry. Proficiency in using analytical instruments such as HPLC, GC, LC-MS, and spectroscopy. Strong understanding of regulatory requirements (e.g., FDA, ICH guidelines) related to analytical methods. Excellent problem-solving skills and attention to detail. Ability to work independently and as part of a team in a fast-paced environment. Strong written and verbal communication skills. Perks and benefits Opportunity to work on innovative research projects that contribute to groundbreaking therapies. Collaborative and inclusive work environment that values professional growth and development. Competitive salary and benefits package. A chance to make a real impact in the field of pharmaceutical research. How to Apply: Interested candidates are invited to submit their resume and a cover letter outlining their experience and qualifications to business@offtargets.com

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"

FD of Injectable Products like solutions, Lyo Products, suspension and complex products like iron collids, Peptide and should be familiar with advance analytical characterization. Literature search of new product, conduct pre formulation studies Required Candidate profile Ability of carry out investigations, trouble shooting exercise Exp- 6-8years if Mpharma & 2-3years if PHD

Job Description We are looking for an experienced and dynamic Team Leader to head our Analytical Research team within the Pharmaceutical R&D division, focused on complex injectable products and 505(b)(2) submissions . This role is ideal for a candidate with a strong background in pharmaceutical R&D , robust team management skills , and deep understanding of injectable formulation analytics . Key Responsibilities Lead and manage the analytical research team supporting complex injectable development. Supervise daily lab operations, resource allocation, and project timelines. Drive method development, validation, and troubleshooting for injectable formulations. Provide scientific leadership and ensure data quality and regulatory compliance. Maintain high team morale and cultivate a positive, collaborative work environment. Guide preparation of analytical documents for regulatory filings (505(b)(2), ANDA, etc.). Impart training, develop team capabilities, and mentor junior scientists. Collaborate closely with formulation, quality, and regulatory teams. Ensure compliance with cGMP, GLP, and internal SOPs. Desired Candidate Profile Qualification: M.Pharm / Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, or related field. Experience: 8+ years in Pharmaceutical R&D , minimum 3 years in a leadership/supervisory role . Hands-on experience in analytical method development for complex injectables (liposomes, suspensions, emulsions, etc.). Sound knowledge of 505(b)(2) regulatory pathway . Strong command of analytical techniques: HPLC, GC, spectroscopy, particle size analysis, etc. Proven track record in team leadership, project coordination , and technical problem-solving . Excellent communication and interpersonal skills. Key Skills Analytical R&D, Complex Injectables, Injectable Formulations, Team Management, 505(b)(2), Method Development, HPLC, GC, Troubleshooting, Pharmaceutical R&D, Training & Mentoring

Sun Pharmaceutical Industries Limited WALKIN DRIVE @ BARODA Function : MS&T - Injectable Experience : 1 to 6 years Qualification : B.Pharm/M.Pharm Job Location : Halol - Gujarat Date of Interview : 11th May 2025 || Time : 9.30 am - 1.00 pm. Venue of Interview : Sun Pharmaceutical Industries Limited, Near Akshar Chowk, Tandalja Road, Vadodara - 390012 Job Description: Execution of technology transfer to Sun/CMO Site transfer, Scale up, Exhibit, Process validation batches plan with effective planning and utilization of men, materials and machineries. Documentation work like new production introduction form, Scale-up reports, review of Sun/CMO BMR, sampling plan, PV protocol, URS preparation, and Dashboard preparation. To ensure that product is produced and stored according to the appropriate documentation in order to btain the desired quality. Responsible for Review & comments of MF, FMEA, RA & protocol (Sampling plan, Process validation protocol) and compliance. Handling & Support of Trouble shooting batches for data comparison and route cause Investigation at Sun/CMO. Investigation for product trouble shooting To ensure that the Packing operations or activities are carried out on timely. To monitor & prior checkup of equipment planned for usage in Scale up, Exhibit, Process validation batches i.e. Equipment preparation, vial washing & dehydrogenation, CIP/SIP System, PLCs, instruments etc. Responsible for Supervise and perform skid trials for better product development and process improvements and also minimizing manufacturing related constraints in future. To prepare the Scale up report, get evaluated and signed by authorized person prior going to Exhibit batches & their submitted to QA. Responsible to help the officers and operators to standardize production activities to achieve better efficiency and quality. To review validation protocol, SOP and other cGMP Documents. Close coordination with all the supporting departments i.e. Production, NPQC, QA, QE (Engineering) and warehouse for smooth running of Scale up, Exhibit, Process validation batches. To ensure the compliance of various in-process control instructions provided in MF, FMEA, RA, BMR, and MBMR.