11 Sep
|
Khandelwal Laboratories
|
Mumbai
11 Sep
Khandelwal Laboratories
Mumbai
Location- Thane
Note- Experience in oncology or injectables segment is required.
We are looking for a seasoned Plant Head to lead end-to-end manufacturing operations at our pharmaceutical facility in Thane. The role requires a strategic leader with extensive experience in managing large-scale plant operations, ensuring regulatory compliance, and driving operational excellence across production, quality, and supply chain functions.
Key Responsibilities
- Lead and manage daily plant operations, ensuring achievement of production targets with optimum resource utilization.
- Oversee Production, Quality (QA/QC), Engineering, Maintenance, and Supply Chain functions.
- Ensure strict adherence to cGMP, FDA, and other global regulatory standards, including compliance with Pharmacopeia and Drugs & Cosmetics Act.
- Drive operational excellence initiatives such as process optimization, yield improvement, OEE enhancement, and cost reduction.
- Manage plant budgeting, including OPEX and CAPEX planning, tracking, and control.
- Lead technology transfer, scale-up activities, and current product commercialization.
- Ensure readiness for regulatory audits (USFDA, MHRA, etc.) and maintain audit compliance standards.
- Implement and maintain EHS policies to promote a zero-incident safety culture.
- Handle plant expansion, capacity enhancement,
and project execution initiatives.
- Develop and mentor large cross-functional teams, driving performance, engagement, and capability building.
- Ensure compliance with all local statutory and regulatory requirements for uninterrupted plant operations.
- Collaborate with internal and external stakeholders, including vendors and third-party manufacturers.
Key Skills & Competencies
- Strong expertise in Pharmaceutical Manufacturing Operations (OSD / Injectables preferred)
- In-depth knowledge of Regulatory Compliance & Audits (USFDA, EMA, MHRA, etc.)
- Proven leadership in plant management, project execution, and capacity expansion
- Experience in technology transfer and ANDA-related activities
- Strong understanding of lean manufacturing and continuous improvement practices
- Expertise in supply chain optimization and third-party manufacturing
- Excellent people leadership, strategic thinking, and decision-making skills .
Experience Required
- 12+ years in Pharmaceutical Manufacturing
- Minimum 5 - 10 years in a senior leadership role (Plant Head / Site Head / Sr. Operations Leader)
- Experience handling large-scale operations and regulatory-approved facilities
- Exposure to Injectables and/or OSD manufacturing is highly preferred
📌 Plant Manager - Injectables/ Oncology (Mumbai)
🏢 Khandelwal Laboratories
📍 Mumbai