1) Candidate should have understanding and experience in development of different types of oral dosage forms like immediate release formulation/delayed release formulations/ pellet coating and controlled release formulation,hard gelatin capsule, soft gelatin capsules, solutions, suspensions, dry powders and syrups for different Regulated and semi regulated markets.
2) Carry out pre-formulation and formulation development experiments for new chemical entities and ANDA formulations.
3) Develop new technology platforms and conduct feasibility studies for novel formulations such as microspheres, pellets, and spherules, aqueous and non-aqueous suspensions, ophthalmic and spray coated particles using various polymers. This includes preparation of prototype formulations for bio/clinical studies, analyzing experimental data and preparation of technical reports. Follow existing or prepare new SOPs and equipment operating procedures.
4) Design, develop and conduct appropriate dissolution studies for the novel dosage forms. Prepare stability protocols and collect the stability data. As per ICH guidelines, set specifications for raw materials and finished products. Organize tech transfer of developed products to plants for the manufacturing of scale up, exhibit, clinical or bio study batches. Review bio study and clinical study designs and protocols. Support clinical supply manufacturing and labeling activities along with drug supply inventory control and reconciliation.
5) Maintain inventory and reconciliation of Innovator products. Maintenance and up keeping of the lab and pilot areas. Give timely support in resolving regulatory queries.
6) Analyze and interpret significance of bio/clinical study results. Preparation and review of registration lot documents, technical reports and submission related documents in accordance with the applicable FDA and ICH guidelines such as CMC and CTD sections of IND, 505(b)2, NDA and Para III and IV certified ANDA. Interact with QC, QA, Regulatory, Marketing, Clinical, Purchasing and Commercial departments for the successful development of new products. Maintain and follow safety standards as issued by the Company.
5 to 7 years of previous experience
Post Graduation in Pharmaceutical Technology or Pharmacy
CollaborationCustomer CentricityDeveloping TalentInnovation & CreativityProcess ExcellenceResult OrientationStakeholder ManagementStrategic Agility5. Result Orientation2. Innovation & Creativity1. Strategic Agility6. Process Excellence7. CollaborationAdaptability/FlexibilityBuilding Positive Working Relationships
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 23,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
