9 Liposomes Jobs

Role & responsibilities: Candidate should be experience in Complex Injectable dosage form such as Liposomes, Microspheres, Nanoparticles, polymeric multi-particulate systems, Depot formulation, Suspensions, Lyophilized powders, colloidal suspension, and peptides/protein based formulations. Literature search, understanding of Quality by design, design of experiments, US-FDA product specific guidance, EMA guidelines, ICH guidelines, Statistical tools required in product development. Exposure of different softwares and tools required for QBD and DOE. Prototype formulation design to Lab scale development, process optimization using DOE and modern approach. Understating of complex APIs, Polymers,...

Role Overview: As a Regulatory Affairs Specialist at our company, your role involves preparing regulatory strategies for complex products such as injectables, peptides, microspheres, liposomes, nano-suspensions, ophthalmic, otic, topical gel, DDCP, etc., as well as 505(b)(2) products for the US and EU markets. You will be responsible for drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products and 505(b)(2) products. Additionally, you will review API and FP in-vitro characterization/sameness reports, as well as DMF reviews for complex APIs, while collaborating closely with cross-functional teams. Key Responsibilities: - Prepare...

Key Responsibilities JOB DESCRIPTION Your Responsibilities Include, But Are Not Limited To Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft controlled correspondences on complex issues. Draft Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. Qualifications M...

Key Responsibilities JOB DESCRIPTION Your Responsibilities Include, But Are Not Limited To Prepare Regulatory strategies for Complex Products [like injectables that may include Peptides, Microspheres, Liposomes, Nano-suspensions etc./ Ophthalmic/ Otic/ Topical gel/ DDCP etc.] and 505(b)(2) Products for US and EU market. Draft Pre-ANDA/Pre-IND/ScA meeting packages for US and EU market. Draft controlled correspondences on complex issues. Draft Deficiency responses for Complex Products and 505(b)(2) Products. Review API and FP in-vitro characterization/sameness reports. DMF review for complex APIs as per the workflow. To collaborate and work closely with cross functional teams. Qualifications M...

As a Research Chemist in our team, you will be responsible for conducting multistep organic synthesis and reaction optimization on a lab scale. Your expertise in handling various lab reactors like glass, stainless steel, and jacketed reactors will be crucial. Operating and calibrating lab instruments such as rotary evaporators, vacuum pumps, stirrers, pH meters, and ovens will be a part of your daily tasks. Additionally, you will be conducting product purification using techniques like distillation, crystallization, extraction, and chromatography. It is essential to maintain accurate documentation of experiments, batch records, and lab observations while following SOPs, safety guidelines, an...

Role Overview: As a Regulatory Affairs Specialist at Amneal, your primary responsibility will be to prepare regulatory strategies for complex products such as injectables, ophthalmic, otic, topical gel, and 505(b)(2) products for both the US and EU markets. You will be drafting Pre-ANDA/Pre-IND/ScA meeting packages, controlled correspondences, and deficiency responses for complex products. Additionally, you will review API and finished product in-vitro characterization reports, collaborate with cross-functional teams, and ensure compliance with regulatory standards. Key Responsibilities: - Prepare Regulatory strategies for Complex Products including injectables, peptides, microspheres, lipos...

Job Purpose: To lead and execute formulation development of Novel Drug Delivery Systems (NDDS) in the injectable segment, including liposomes, microspheres, nanoparticles, depot injections, and other complex injectable formulations for regulated and semi-regulated markets. Key Responsibilities: Design and develop NDDS injectable formulations such as liposomes, emulsions, microspheres, suspensions, nanoparticles, and depot systems. Conduct pre-formulation and formulation studies, compatibility studies, and risk assessments. Execute lab-scale and scale-up batches as per QbD principles and DoE designs. Evaluate and finalize suitable processes, components, and primary packaging materials. Ensure...

As a highly skilled and experienced Research Chemist with a Master's degree in Organic Chemistry and at least 5 years of hands-on experience in laboratory research and development, your expertise in organic synthesis, process development, and delivery system optimization will play a crucial role in supporting innovative R&D initiatives, lab-scale synthesis of active ingredients, and enhancing formulation and delivery systems for cosmetic or specialty chemical applications. Key Responsibilities: - Perform multistep organic synthesis and optimize reactions on a lab scale - Operate and maintain various lab reactors including glass, stainless steel, and jacketed reactors - Handle and calibrate l...

Hands on Experience on Regulatory Affairs of various ROW markets. Lead the team for day to day RA activity. Required Candidate profile Experience of working on Liposomes/Pegylated Liposomes/Microspheres/Resomer baseddepot/Dual chamber based components / Particle size based delayed drug delivery injectables/Lyophilised dosage forms.a