Manager - Technical Services (Formulation Development)

Role & responsibilities

Job Purpose

The incumbent leads the Formulations / Process development function at the plant and is also responsible for Formulations / Process development at third party sites across India. Accountable for introduction of new products, reformulation of existing products, operational excellence projects, technology transfers, troubleshooting, new vendor development.

POSITION RESPONSIBILITIES

• Lead the organization in development and innovation of New Products, Product Enhancement and Product Redesign to meet customer and consumer needs and expectations
• Lead a cross functional team to understand the needs of the customer and manage and recommend formulations, processes, ingredients, packaging and equipment to bring assigned projects to successful conclusion.
• Lead and manage project schedules and milestones
• Lead a cross functional team to manage technology transfer activities of the organization.
• Lead trouble shooting activities of the organization and Third-Party sites.
• Approve new vendors through evaluation and validation studies
• Manage project costs and other departmental activities within budget
• Develop and innovate New Product and Process designs that meet customer and consumer expectations for cost and quality.
• Understand the needs of the customer and manage and recommend projects that would lead to opportunity for continued brand recognition Set and implement departmental policies, objectives and initiatives
• Ensure technology transfer and scale-up activities of products ready for commercialization at Third Party sites and In-house
• Evaluate product life cycles and trend analysis
• Support the vendor development process and participate in third party audits
• Ensure departmental adherence and compliance with appropriate regulatory requirements.
• Improve safe work conditions and safe working practices to have zero accidents and environment friendly operations.
• Adherence to local legal requirements, EHS policy and EHS standards/ programs/ SOPs to ensure compliance and improve the safety culture.
• Participate in safety meetings, EHS programs and EHS events and proactively report and address EHS issues and Near Misses.
• Ensure commissioning of new equipments procured for F&D use.
• Ensure that the calibration of equipment for F&D is completed satisfactorily as per the respective due date.
• Support the development and approval of master manufacturing documents and packing specifications for products manufactured at CMO sites.
• Approve the training curriculum assignment and job code allocation for new joiners in the department.
• Ensure that the standard operating procedure is followed in the department.
• Initiate or approve the payment orders for procurement of materials, external testing orders and chemicals for departmental use.

Skills / Knowledge / Qualification / Experience

• M. Pharm / PhD. with minimum 15 years of experience in pharma.
• Strong understanding of:
• Formulation principles and excipient functionality
• Stability studies and ICH guidelines
• GMP / GLP / regulatory requirements
• Time management and ability to handle multiple projects

COMPETENCIES

Functional and technical skills

The individual should possess good functional and technical skills to perform the job. Shall thrive in a changing environment and technology.

Demonstrate Business Acumen 

Knows how businesses work; knowledgeable in current and possible future policies, practices, trends, technology, and information

Process Management

Good at figuring out the processes necessary to get things done; knows how to organize people and activities; understands how to separate and combine tasks into efficient work flow