Job Description: Production Manager – Steroid APIs
Company: Vartika Chemicals and Pharmaceuticals
Position: Production Manager
Department: Manufacturing / Production
Employment Type: Full-Time
About the Role
Vartika Chemicals and Pharmaceuticals is seeking an experienced Production Manager to lead manufacturing operations for our steroid API product line, with specific expertise in Methylprednisolone Sodium Succinate and Hydrocortisone (and its salts/esters). The ideal candidate will have hands-on plant experience in corticosteroid synthesis and formulation, strong regulatory compliance knowledge, and a proven record of managing production teams in a GMP-regulated pharmaceutical/API environment.
Key Responsibilities
- Plan, supervise, and optimize batch production of Methylprednisolone Sodium Succinate, Hydrocortisone, and related corticosteroid APIs/intermediates
- Ensure production schedules meet output, quality, and delivery targets
- Oversee reactor operations, crystallization, drying, purification, and sterile/aseptic processing steps as applicable
- Ensure strict adherence to cGMP, GLP, and regulatory guidelines (USFDA, WHO-GMP, EU-GMP as applicable)
- Coordinate with QA/QC, R&D, and Regulatory Affairs for process validation, deviation handling, and CAPA
- Manage yield optimization, batch record review, and process troubleshooting
- Lead, train, and supervise shift supervisors, chemists, and plant operators
- Maintain SOPs, batch manufacturing records (BMRs), and ensure documentation accuracy
- Monitor raw material consumption, plan procurement needs with SCM, and control production costs
- Ensure workplace safety, environmental compliance, and proper handling of hazardous/steroid-class materials
- Drive continuous improvement initiatives (Lean, Six Sigma, or equivalent) to enhance efficiency
Required Qualifications
- B.Sc./M.Sc. in Chemistry, or B.Pharm/M.Pharm, or B.Tech/M.Tech in Chemical Engineering
- Minimum 8–12 years of experience in API/bulk drug manufacturing, with at least 3–5 years specifically in corticosteroid/steroid API production (Methylprednisolone, Hydrocortisone, Prednisolone, or related molecules preferred)
- Strong knowledge of steroid synthesis routes, esterification/succinate ester formation, crystallization, and purification techniques
- In-depth understanding of cGMP, regulatory audits (USFDA/WHO-GMP), and documentation practices
- Experience handling potent/hazardous APIs and containment procedures
- Proven team management and leadership skills
- Strong problem-solving and process troubleshooting ability
Preferred Skills
- Experience with technology transfer and scale-up from R&D to commercial production
- Familiarity with SAP/ERP systems for production planning
- Exposure to regulatory inspections and audit readiness
What We Offer
- Competitive salary (commensurate with experience)
- Opportunity to lead a specialized, high-value API manufacturing line
Pay: ₹80,000.00 - ₹100,000.00 per month
Benefits:
- Commuter assistance
- Leave encashment
- Provident Fund
Work Location: In person
