Alkem Laboratories, Taloja

2 Job openings at Alkem Laboratories, Taloja
Analytical Chemist navi mumbai 1 - 2 years INR 3.0 - 4.0 Lacs P.A. Work from Office Full Time

Role & responsibilities Method Development & Validation for In-Vitro studies (NG/G feeding tube and binding studies) Analytical Techniques: Basic knowledge of Particle Size Distribution (PSD) and High-Performance Liquid Chromatography (HPLC) Instrument Calibration & Qualification Documentation & Regulatory Compliance for method validation and studies Operation of Camera/Video Camera for study documentation Data Compilation & Reporting (including study photographs) Preferred candidate profile 1. Method development for the In-Vitro feeding tube (NG/G tube) and binding study. 2. Method validation for the In-Vitro feeding tube (NG/G tube) and binding study. 3. Invitro feeding tube (NG/G tube) study. 4. Invitro kinetic and equilibrium binding study. 5. Calibration and qualification of Instruments/Equipments. 6. Documentation for all method validation / study. 7. Instrument Basic knowledge of Particle Size Distribution (PSD)/ High-Performance Liquid Chromatography (HPLC). 8. Operation of camera/Video camera. Compilation of study photographs as per regulatory requirements.

Portfolio Management & In-Licensing Executive navi mumbai 1 - 2 years INR 7.0 - 7.5 Lacs P.A. Work from Office Full Time

Role & responsibilities Knowledge of IP/Formulation/Market Analysis OR 12 years in Portfolio Management & In-Licensing Preferred candidate profile Identify therapy gaps in the product portfolio and play a key role in new product selection (Generics, differentiated products, biosimilars, 505(b)(2), niche/orphan therapy areas). Conduct preliminary Pharmaceutical/IP/Competitive Intelligence and mapping to identify opportunities and threats across therapeutic areas for portfolio prioritization and early development candidates. Evaluate and select new products across dosage forms to expand the global product portfolio and maintain a healthy pipeline. Understand basic regulatory concepts such as first-filer exclusivity, ANDA, NDA, and approval processes across geographies. Perform preliminary analysis of product parameters (market sales, competition, patent expiry, therapeutic category, API suppliers, technical complexity, BE studies, feasibility of manufacturing with CAPEX involvement). Assess in-licensing opportunities based on clinical advantage and market potential through surveys. Basic knowledge of Artificial Intelligence applications in pharma. Key Competencies: Excellent Communication Skills Strong Cross-Functional Team Collaboration Proficiency in Microsoft Excel & PowerPoint Self-Starter with Analytical Thinking