Role & responsibilities 1.Machinery Breakdown Management. 2. Operation and Preventive Maintenance. 3. SOP Preparation and Documentation. 4.Training and Development. 5.Equipment Qualifications. 6.Documentation and Data Management. 7.Material Coordination. Description: Attend or delegate personnel to attend machinery breakdowns promptly Monitor and verify the operation, preventive maintenance, and troubleshooting of process equipment. Responsible for qualifications (IQ, OQ, PQ), requalification, and revalidations of process equipment.

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.

Role & responsibilities Extensive Knowledge in Pre-Submission activity and handling new product submissions. Handling of post approval activities (US/EU and ROW) Experience in handling life cycle management Activities. Line Extension and New Submissions. Well versed in applicable regulatory and country specific guidlines.

Role & responsibilities Sourcing and procurement of APIs and their impurities, and developing new or alternative vendors. API indents and planning as per the monthly production or PD schedule, coordinating with the PPIC Team and Warehouse team. Conducting due diligence audits of API facilities. Coordinating with the Regulatory and Quality Teams to arrange responses from vendors for queries and investigations. Experience in making monthly purchase statements, generating purchase orders, and work orders, as well as generating purchase performance reports on a bimonthly basis. Evaluating CDMOs for the synthesis of new APIs. Sound knowledge in vendor qualification and 21 CFR compliance, as well as licenses related to API vendors. Hands-on experience in drafting and negotiating agreements with API vendors.

Job Responsibilities : Develop and validate IVIVC and PBPK models to predict in vivo drug performance from in vitro data. Conduct in vitro experiments such as solubility, dissolution, and permeability studies using biorelevant media. Collaborate with formulation, analytical, and clinical teams to optimize drug product development. Analyze bioequivalence (BE) study data and support regulatory submissions with modeling insights. Prepare and review technical reports, protocols, and regulatory documentation . Preferred candidate profile & Qualifications: Should be well versed with IVIVC concepts,preferably 5-10 years of experience. Should have excellent knowledge on product development and clinical studies. Should have hands on experience on operating various simulation tools necessary for IVIVC. Excellent communication skills are must. Strong knowledge of oral solid dosage forms (OSDs) and excipient functionality. Experience with regulatory guidelines (e.g., USFDA, EMA) related to IVIVC and BE studies. M.Pharm or Ph.D. in Pharmaceutics, Biopharmaceutics, or Pharmaceutical Sciences.

Role & responsibilities Product Strategy & Planning Define development strategy for injectable formulations (solutions, suspensions, emulsions, lyophilized products) Align product pipeline with regulatory and market needs (US/EU/ROW) Formulation & Process Development Lead pre-formulation studies, excipient compatibility, and prototype development Oversee scale-up, optimization, and validation of manufacturing processes Cross-Functional Leadership Collaborate with R&D, QA/QC, Regulatory Affairs, and Manufacturing teams Manage technology transfer to commercial sites or CROs Regulatory & Compliance Ensure documentation for ANDA/NDA submissions is complete and compliant Support audits and inspections with technical and regulatory expertise Project Management Develop timelines, allocate resources, and monitor progress across multiple projects Mitigate risks and troubleshoot formulation or analytical challenges Innovation & Market Intelligence Stay updated on novel delivery systems (e.g., liposomes, microspheres, depot injections) Benchmark competitors and identify opportunities for differentiation Preferred candidate profile Essential Skills & Competencies -Deep knowledge of injectable dosage forms, aseptic processing, and formulation science -Familiarity with FDA, EMA, ICH guidelines and dossier preparation -Ability to lead cross-functional teams and manage timelines effectively -Skilled in preparing MFRs, BMRs, SOPs, and handling change controls -Capacity to explore new technologies and delivery platforms -Strong verbal and written skills for internal coordination and external presentations -13-18 years of experience in pharmaceutical industry with expertise in injectables product development. -M.Pharma degree or equivalent qualification (e.g., Ph.D./Doctorate). -Proven track record of successfully leading complex projects from ideation to execution. -Strong understanding of global regulations governing pharmaceuticals (e.g., FDA, EMA).

Role & responsibilities: Outline the day-to-day responsibilities for this role. Preferred candidate profile: Specify required role expertise, previous job experience, or relevant certifications.