Jobs at DifGen Pharmaceuticals

Support new research projects within the group by performing experimental work, data collection and documentation, and collaborating with team members to advance project objectives.

Senior QA responsible for reviewing and submitting exhibit batch manufacturing and packing records, process validation and hold-time protocols/reports, executed media fill records, equipment qualification documents, and QMS documents (change control, deviations, CAPAs) for regulatory submissions.

Support execution of commercial launches, scale-up and validation batches at internal and CMO manufacturing sites. Prepare and review BMRs and validation protocols/reports, coordinate cross-functional knowledge transfer, participate in investigations and deviation handling, assist equipment selection, support regulatory submissions and audits, and maintain GMP-compliant documentation and reporting.

Support process technology transfers and execution of scale-up, exhibit, and commercial batches under GMP. Prepare and review BMRs, validation protocols/reports, and regulatory submission documents. Coordinate with R&D, QA, QC, Regulatory, and Manufacturing, assist in investigations, equipment selection, audits, and produce technical reports and presentations.

Support technology transfer and scale‑up for OSD products, providing technical oversight, executing batches, reviewing/approving validation and regulatory documents, driving investigations and remediation, and collaborating with Quality, Ops, Engineering and Development. Ensure validated, robust processes and product compliance. Frequent travel to CMOs (India and overseas) for on‑site support.

Lead review and approval of packaging materials and related documentation for new product development, including sourcing, vendor finalization, specifications, MPCs, BOMs, change controls, testing protocols, and design history files. Coordinate with CFTs, CMOs, and suppliers to support scale-up, exhibit batches, and documentation control. Prepare SOPs, bracketing sheets, and protocol-driven functionality and qualification studies.

Review and submit exhibit batch manufacturing and packing records, validation protocols and reports, media fill records, equipment qualification documents, and QMS items including change control, deviations, and CAPA for regulatory submissions.

Lead design and development of sterile pharmaceutical formulations, plan and run experiments and stability studies, analyze results, prepare technical and regulatory reports, support scale-up and tech transfer, collaborate with Production/Quality and cross-functional teams, and manage product lifecycle from ideation to end-of-life.

Support preparation and submission of regulatory documents, track global regulatory updates, maintain regulatory files and PLCM, collaborate with QA/R&D/Manufacturing, review labeling/promotional materials for compliance, conduct regulatory intelligence, and provide administrative support.

Receive, check, and store deliveries; maintain inventory records and systems; perform regular stock takes; pick and deliver products using a forklift; and distribute goods to departments as required.

Support analytical R&D by developing and optimizing HPLC and GC methods. Act as SME for method development and perform basic instrument operation and maintenance.

Support AR&D by creating and managing analytical and project documentation, coordinating change control and cross-functional needs (QA, Purchasing, Regulatory), assisting DMF review, preparing validation/transfer protocols and stability support, and executing document control in TrackWise to advance product development projects.

Review and approve pharmaceutical study protocols and reports for regulatory compliance; act as QC SME guiding QC processes, investigate CMO deviations and CAPAs, support data integrity and electronic QC systems, participate in audits, and drive continuous quality improvements.

Support preparation and submission of regulatory documents (e.g., ANDA/MAA/ANDS/IND), research regulatory requirements, maintain regulatory files, collaborate with QA/R&D/Manufacturing, review labeling, monitor regulatory updates, and provide administrative support.

Lead formulation and product development for pressure-sensitive adhesive systems: literature and patent review, formulation design using QbD, pre-formulation screening, stability studies and DOE, analytical data interpretation, tech transfer documentation, SOP preparation, instrument calibration, and project monitoring to meet timelines.

Review raw analytical data, worksheets, instrument printouts, test reports and COAs for accuracy and compliance. Verify calculations, chromatograms, integration parameters, and result interpretations. Ensure ALCOA+ and data integrity. Review analytical methods, specifications, and QC-related deviations (OOS/OOT), incident reports, CAPA, and change controls. Ensure scientifically justified root cause, impact assessment, and CAPA effectiveness.

Support preparation and submission of regulatory documents for generic pharmaceuticals, research regulatory requirements, maintain regulatory files, collaborate with QA/R&D/Manufacturing, review labeling, monitor regulatory updates, provide administrative support, and assist project leader with related tasks.

Perform formulation analytical R&D for oral solid dosage (OSD) or injectable products including method development, method validation, method transfer, and routine analytical testing.

Support inventory documentation and reporting, perform cycle counts and periodic stock checks, help monitor stock levels and reordering, ensure proper storage and safety, and collaborate with cross-functional teams on inventory discrepancies.

Support analytical development by performing routine analyses and assisting with internal method validation and other analytical department tasks.