Senior Executive Technical Operations | Abbott | Baddi

Job Description

Primary Job Responsibilities:

• Scale Up/ Scale Down: Batch size change of the existing product in such a way resulting in Line balancing & optimum capacity utilization of line and equipment.
• Transfer of product from one line to another using scaleup factor using different process engineering tools i.e. mixing in RMG/ Blender, dwell time calculation in compression, and mass balancing in coater.
• Troubleshooting regular commercial products to support timely deliverance.
• Process simplification/ improvement at the manufacturing and packing stage to reduce cycle time and improve compliance.
• Recipe Finalization of product at different stages to have better process control, product consistency, and reproducibility.
• CMC remediation of identified products having consistent process/ analytical/ stability issues.
• Process Capability improvement of the identified product having CpK<1.3 for CQA.      
• Cost-saving initiatives: Cost-saving projects compete through Yield improvement, AVD, and cycle time reduction.
• Alternate Vendor Development: Specification designing/ updation for effective and right-first-time implementation of alternate vendors. Technical support for evaluation, trial, and validation with new vendors.
• Provide technical input while selecting new equipment considering process nature and product demand.
• Basic understanding of Packaging development and Troubleshooting for any packaging-related issue observed during blister/ strip/ bulk or bottle packing.      
• Analytical method development: Experience in product analytical method development/transfer and any technical input required for smooth transfer including troubleshooting.

Major Responsibilities:

Product technology transfer:

From Innovation and Development (I & D Mumbai):

• Act as a receiving team for new products transfer from I & D to AHPL, Baddi.
• Right first-time internalization of I&D transfer products to Baddi and its life cycle management after a successful launch.

From other Sites:

• Successful product transfer from Third Party or other Abbott site to Baddi through gape assessment, equipment equivalency, and calculating scale-up factor.

Supervisory/Management Responsibilities:

Should involve in the following supervisory activities to support cross-function activities:

• To provide technical training to Manufacturing and Packing team.
• Support for investigations (OOS/OOT/deviation) and market complaints to identify RCA and provide the technical solution of any process issue as part of CAPA.
• To perform a risk assessment and evaluate the change impact in case of any change in process/ equipment/ RM/PM.
• Provide technical support for the externalization of the products to other Abbott sites/ TP/ LL.

Accountability / Scope:

• Product Technology Transfer from I&D/ TPM/ LL to Baddi.
• To provide technical support to the Baddi team in a regular commercial.

Education & Experience:

• M.Pharm (preferably in pharmaceutics) with 6-9 years experience.