Production Head - Oncology

About Company:

Our client is a global pharmaceutical company dedicated to developing, manufacturing, and distributing high-quality generic medicines, specialty pharmaceuticals, biosimilars, and injectable products. Founded in 2002, the company is headquartered in Bridgewater, New Jersey, USA, and serves patients in more than 100 countries. It operates multiple manufacturing and R&D facilities worldwide, including major operations in India, supporting a broad portfolio across numerous therapeutic areas such as oncology, neurology, endocrinology, and infectious diseases.

An Ideal Candidate:

Ideal candidate should have 20–25 years of experience in regulated sterile injectable manufacturing facilities with B. Pharmacy/ M. Pharmacy qualification. Mandatory experience in an oncology manufacturing facility. Hands-on experience in the manufacturing of complex molecules in sterile injectable dosage forms and directly leading and managing USFDA inspections/audits.

Key Competencies:

1. To review, develop and introduce systems, practices and cultural changes that enable the production department to meet business demands within agreed time frames and expected GXP standards.
2. To prepare production planning on monthly basis as per the production requirement and availability of materials.
3. To discuss production plans with subordinates and scheduling weekly plans / allocation of weekly shift schedule.
4. Daily work allocation to supervisors & workmen. Achieving set targets of daily/weekly /monthly manufacturing/packaging plan.
5. To interact with Warehouse/QC/QA for the material availability / release and schedule the production plan.
6. To propose and implement innovative ideas towards improvements in process efficiency, productivity, delivery, quality, yield, safety resulting in successful operations.
7. To manage the troubleshooting activity, ensuring identification of appropriate corrective measures and driving structured implementation of these measures through cross-functional teams.
8. To perform Gap analysis of defined procedures in Batch Manufacturing Record / Batch Packing Record / Standard Operating Procedure / Protocol and initiation of corrective actions.
9. To impart continuous training to the workforce for enhancing their productivity & operational efficiencies through knowledge enhancement / skill building.
10. To ensure effective execution of new product introduction and technology transfer of any product to the Site.
11. To prepare & review of SOPs related to production department.
12. To review of documents like log books, BMR, BPR for error free online documentation and timely submission to QA.