Manager / Senior Manager – Manufacturing Downstream
Intas Pharmaceuticals Ltd. is seeking an accomplished biopharmaceutical leader for its advanced Plasma Fractionation Centre in Ahmedabad. The position oversees downstream manufacturing workflows, monthly scheduling, cGMP compliance, BPR reviews, and qualification protocols (IQ/OQ/PQ & Process Validation).
Plasma Fractionation Unit
Intas operates a dedicated, world-class Plasma Fractionation plant in Ahmedabad, focusing on critical plasma-derived medicinal products including Albumin, Immunoglobulins, and specialized factor concentrates.
Process Validation & Qualification
Spearhead rigorous technical validation protocols including IQ, OQ, and PQ for automated downstream skids, chromatography columns, tangential flow filtration systems, and cleanroom hardware.
Global Regulatory Alignment
Maintain continuous readiness for international audits (USFDA, EMA, WHO, MHRA) ensuring 100% data integrity, standardized BPR documentation, and active deviation closure via root-cause investigation.
About Intas Pharmaceuticals Ltd.
Ranked among India’s top 10 pharmaceutical companies with global operations in more than 85 countries and presence across North America and Europe through Accord Healthcare.
Key Operational Duties & Responsibilities
6 Core Focus AreasProduction Planning & Batch Yield
Formulate and coordinate monthly downstream manufacturing schedules. Supervise daily shift allocations to ensure targeted recovery yields and zero batch rejects in fractionation suites.
BPR Review & Technical Documentation
Draft, technically assess, and approve Batch Production Records (BPR), cleaning logs, standard operating procedures (SOP), and downstream process flow diagrams.
Qualification Protocols (IQ / OQ / PQ)
Lead downstream equipment qualifications (Installation, Operational, and Performance Qualifications) and Process Validation (PV) protocols for chromatography and ultrafiltration setups.
User Requirement Specifications (URS)
Define and review URS documentation for incoming downstream processing skids, single-use systems, sterile filtration assemblies, and automated virus inactivation tanks.
Deviations, CAPA & Change Control
Spearhead root-cause analysis (RCA) investigations for unexpected manufacturing events, deviations, and out-of-specification occurrences, ensuring comprehensive CAPA execution.
SAP Operations & Floor Compliance
Supervise end-to-end material issuance, goods movements, batch confirmations, and scrap bookings within SAP Production Module while maintaining cGMP compliance.
Eligibility & Academic Criteria
Discipline: Biotechnology, Biochemistry, Microbiology, or Biochemical Engineering.
Proven leadership tenure in biopharmaceutical or plasma fractionation downstream processing facilities.
Plant Location: Plasma Fractionation Unit, Ahmedabad (Gujarat).
Technical & Domain Competencies
- Unit Operations: Hands-on proficiency with chromatography columns (affinity, IEX, HIC), ultrafiltration/diafiltration (UF/DF), and viral clearance cascades.
- Regulatory Inspections: Established record of presenting downstream documentation during USFDA, MHRA, and WHO qualification audits.
- Digital Enterprise: Working knowledge of SAP PP/QM modules and automated SCADA control systems.
- Leadership: Proven capacity to train, lead, and mentor shift engineers, operators, and cross-functional teams in cGMP cleanroom zones.
Direct Submission Channel
Qualified biopharma downstream professionals are invited to forward their curriculum vitae directly to Intas Talent Acquisition.
Pharma Rising Notice: Intas Pharmaceuticals and Accord Healthcare do not ask for any deposit or monetary consideration from candidates during recruitment. Always verify official correspondences originate from the official domain (@intaspharma.com).
