Chief Executive Officer - Pharma

JOB DESCRIPTION:

Oversees and manages the entire range of technical and commercial activities at a leading Contract Manufacturing Organizations (CDMOs) including: formulation development, manufacturing, technology transfer, process development, process validation, commercialization, troubleshooting, change management, deviations, and Corrective and Preventative Actions (CAPAs). The CDMO currently operates three manufacturing sites and is adding to its network with an other site for a new dosage form.P & L responsibility for the Contract Manufacturing Organizations (CMO) business of the company;

Key Responsibilities (Indicative list - Not limited to the following) :

- Serve other internal customers of the company viz. exports and trade generics businesses

- Oversees and manages process development and manufacturing activities at CMOs for products in all phases of development in both business and technical capacities.

- Productivity Improvement, Yield enhancement, Quality control and Timely Delivery, Ability to optimize plant capacities, utilities and manpower for cost effectiveness.

- Strong exposure to cGMP/ Regulatory/Statutory requirements and compliance of USFDA, EU and customer audits

- Will have a dotted line responsibility for sales and business development (which reports directly to the Director in-charge of Business Development, New Businesses and Exports

- Responsible for each and every activity of plant including inter -departmental co-ordination - with QA, QC, Engineering, EHS, R &D, Stores, Process Excellence Lab, Technology Transfer, Projects, HR.

- Planning & implementing the preventive & predictive maintenance of Plant, machines, personnel, production, and equipment for improving the overall reliability, safety & maximum efficiency under safe operating conditions.

- Ensure regular Internal Audits are conducted, Root Cause Analysis, Troubleshooting and review to ensure adherence to highest standards.

- To carry out improvement in existing products based on market trends & requirements by cost saving techniques/ measures and modifications to achieve substantial reduction in expenditures and work within the budget.

- Process owner of the ERP system in production operations and ensuring it runs smoothly for achieving operational efficiency.

- Oversee development and implementation of standards, methods and procedures for managing process development and manufacturing activities internally and at CMOs.

- Oversee written communication via protocols, reports and standard operating procedures, exception and change controls, and other document activities.

- Manage and plan budgets and monitor expenses.

Requirements :

CMO experience is absolutely mandatory

- Pharmacy Graduate/PG

- 20 + years of experience in pharmaceutical manufacturing operations with experience in technical development and technology transfer; 12+ years of experience working with CMOs preferred

- Experience managing manufacturing or process development personnel.

- A thorough working understanding of ICH/cGXP Guidelines.

- Strong oral and written communication skills and effective interpersonal skills.

- Ability to influence group or department on business process decisions.

- Must be team oriented and a decision-maker.

- Solid negotiation skills are essential.

- Previous experience interacting with senior management is mandatory.