Manager - Technical Services (Formulation Development)

Pfizer; South Goa District; On-site; INR 6,000,000 - 9,000,000; Full time

Job summary

Pfizer in Goa, India seeks a veteran leader to head Formulations and Process Development. You will oversee development at the plant and third party sites, introduce new products, reformulate existing ones and drive technology transfers while ensuring quality, cost and regulatory compliance.

You will manage cross functional teams, set policies and oversee vendor development, scale-up and safety initiatives to achieve successful commercialization across sites.

Qualifications

• 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.

Responsibilities

• Lead the Formulations / Process development function at the plant and at third party sites across India.
• Introduce new products, reformulate existing products, drive technology transfers and troubleshooting.
• Lead cross functional teams to select formulations, processes, ingredients, packaging and equipment for projects.
• Manage project schedules, milestones and budgets.
• Approve new vendors and participate in third party audits.
• Ensure adherence to regulatory requirements and safe, compliant operations.
• Oversee scale-up and technology transfer activities for commercialization.
• Drive safe work practices and EHS compliance in the department.

Skills

Formulation principles

Excipient functionality

Stability studies

ICH guidelines

GMP/GLP/regulatory requirements

Time management

Education

M. Pharm / PhD

Job description

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