Conducts biopharmaceutics studies to support drug product development. Designs and performs in-vitro dissolution method development and optimization. Establishes in-vitro in-vivo correlations (IVIVC) for oral drug products. Evaluates BCS classification of drug substances for regulatory strategies. Supports Biowaiver applications for solid oral dosage forms. Prepares biopharmaceutics sections for regulatory dossier submissions. Conducts food effect and DDI studies to support product labeling decisions. Collaborates with formulation and pharmacokinetics teams for product design. Reviews pharmacokinetic data and prepares population PK analysis reports. Designs in-vitro permeability and absorption studies using cell-based models. Supports bioequivalence study design and data interpretation activities. Evaluates dissolution specifications for product registration and lifecycle. Stays updated with FDA, EMA biopharmaceutics guidances and BCS classification.

Provides strategic leadership for all clinical operations across development programs. Oversees portfolio of clinical trials from Phase I through Phase IV. Manages clinical operations team and develops organizational capabilities. Leads oversight of CRO partnerships and clinical outsourcing activities. Develops clinical operations standards, processes, and quality systems. Ensures regulatory compliance and inspection readiness across all studies. Manages overall clinical program timelines, budgets, and resource allocation. Supports clinical development strategy with operational feasibility inputs. Leads risk management for clinical programs and implements mitigation strategies. Represents clinical operations at governance committees and regulatory meetings. Builds and maintains relationships with investigators and academic institutions. Mentors clinical operations team members and drives performance management. Stays current with ICH GCP, adaptive trials, DCT regulations, and eClinical tools.

Manages IT infrastructure, systems, and applications for pharmaceutical operations. Oversees ERP system (SAP) administration, upgrades, and user support. Manages computerized system validation (CSV) for GxP-regulated IT applications. Ensures data integrity compliance across all manufacturing and quality IT systems. Manages LIMS, MES, DMS, and other GxP application systems at the site. Leads IT governance including change management, ITSM, and service delivery. Manages cybersecurity program and ensures IT compliance with information security policies. Coordinates with global IT teams on system rollouts and infrastructure upgrades. Manages software license compliance and IT procurement activities. Supports regulatory inspection teams with IT system documentation and access. Manages IT helpdesk and ensures SLAs for system availability and support. Evaluates new pharma IT technologies including IoT, AI, and digital manufacturing. Stays updated with 21 CFR Part 11, GAMP 5, and digital transformation in pharma.

Performs method development and method validation using HPLC and UPLC systems. Conducts routine HPLC analysis for raw material, in-process, and finished products. Operates and maintains HPLC instruments, manages column library and qualification. Performs forced degradation and stability-indicating method development studies. Investigates chromatographic failures and OOS results systematically. Prepares analytical protocols and validation reports per ICH Q2R1 guidelines. Reviews analytical data and approves laboratory notebooks and test reports. Transfers analytical methods between laboratories and manages qualification. Supports regulatory submissions with analytical data and validation packages. Trains junior analysts on HPLC techniques and GLP laboratory practices. Manages CDS (chromatography data system) including Empower and Chromeleon. Ensures data integrity compliance across all chromatography-related activities. Stays current with USP, BP chapters on HPLC and advances in analytical techniques.

Develops nutraceutical, dietary supplement, and functional food formulations. Conducts ingredient screening for efficacy, safety, and bioavailability. Designs stability studies and shelf-life evaluation for nutraceutical products. Develops sensory evaluation protocols for taste, texture, and palatability. Ensures compliance with FSSAI regulations for health supplements and foods. Coordinates claims substantiation with clinical data and evidence reviews. Manages ingredient qualification, safety assessment, and GRAS evaluation. Supports product registration and regulatory filing with FSSAI and APEDA. Develops packaging specifications and storage recommendations for products. Coordinates with marketing for product differentiation and claim messaging. Conducts competitive benchmarking of nutraceutical products in the market. Manages CMO relationships for nutraceutical contract manufacturing activities. Stays updated with FSSAI updates, global nutraceutical trends, and novel ingredients.

Manages strategic relationships with major hospital systems and healthcare chains. Develops and executes hospital account strategies to achieve revenue targets. Coordinates inclusion of company products in hospital formularies. Conducts tender management and government hospital supply activities. Builds relationships with purchase committees, medical directors, and administrators. Organizes scientific presentations, clinical education, and product demonstrations. Monitors competitor activity within hospital accounts and develops counter-plans. Manages hospital tender documentation, pricing, and compliance requirements. Coordinates with supply chain for timely delivery of products to hospital accounts. Prepares account-wise sales analysis and growth plans for management review. Supports new product launches in hospital segment with targeted strategies. Manages outstanding payments and coordinates with finance for collections. Stays current with hospital procurement policies, NPPA pricing, and formulary trends.

Researches and evaluates medicinal plants for therapeutic and pharmacological potential. Develops standardized herbal extracts and conducts phytochemical profiling. Performs botanical authentication and quality testing of crude drugs. Develops and validates analytical methods for marker compounds in herbal products. Conducts in-vitro biological activity screening of plant extracts and isolates. Prepares herbal drug master files and regulatory submissions for AYUSH products. Manages raw material sourcing, authentication, and quality assessment programs. Coordinates with pharmacology teams for safety and efficacy evaluation studies. Prepares dossiers for product registration under AYUSH and international markets. Conducts literature reviews on traditional use, safety, and modern evidence. Supports product development of polyherbal, nutraceutical, and Ayurvedic products. Ensures compliance with WHO monographs and pharmacopoeial herbal standards. Stays updated with AYUSH regulations, GACP guidelines, and global herbal trends.

Develops and executes integrated marketing strategies for the pharma portfolio. Manages brand management team and oversees multiple therapy area portfolios. Designs patient awareness campaigns and healthcare professional engagement programs. Manages digital marketing activities including social media, email, and webinars. Oversees market research, competitive intelligence, and customer insights programs. Manages advertising agencies, market research firms, and event management vendors. Develops launch plans for new products including pre-launch market building. Monitors marketing ROI and optimizes spending across promotional channels. Coordinates with sales leadership for field force activation and field campaigns. Prepares annual brand plans and presents to commercial leadership for approval. Ensures all marketing materials comply with UCPMP and company ethical standards. Supports pricing strategy and market access activities for new products. Stays current with digital health trends, omnichannel marketing, and HCP engagement.

Performs microbiological testing of raw materials, in-process, and finished products. Conducts bioburden testing, sterility testing, and endotoxin (LAL) testing. Performs environmental monitoring of cleanrooms and controlled areas. Conducts microbial limit testing and tests for specific pathogens. Maintains microbial cultures, reference organisms, and culture media. Performs water testing for purified water, WFI, and pharmaceutical water systems. Operates microbiological testing equipment including laminar flow workbenches. Records testing data in laboratory notebooks and LIMS systems accurately. Investigates microbiological OOS results and prepares investigation reports. Performs identification of microbial isolates using biochemical and molecular methods. Ensures autoclave sterilization cycles are validated and routinely monitored. Supports internal audits and regulatory inspection readiness activities. Stays current with USP, BP, and IP microbiological testing monographs and updates.

Operates aseptic manufacturing equipment including fillers, tunnel sterilizers. Performs aseptic fills, vial filling, ampoule sealing, and lyophilization operations. Follows strict gowning procedures and aseptic technique in ISO-classified areas. Conducts environmental monitoring activities including air and surface sampling. Records all manufacturing activities accurately in batch manufacturing records. Participates in media fill qualification and process simulation studies. Performs in-process checks including weight variation, particulate inspection. Assists in equipment cleaning, sterilization, and autoclave operations. Reports deviations and supports CAPA implementation in sterile areas. Ensures all SOPs are followed and maintains contamination control practices. Participates in aseptic technique qualification and requalification exercises. Maintains cleanroom log books and ensures documentation accuracy at all times. Stays updated with WHO annexes, EU Annex 1, and sterile manufacturing guidance.