Site Head

Position Title / Designation : Site Head /Sr. General Manager

Reporting To : V. P. – Manufacturing Excellence Biologicals

Educational Qualification : M.Sc. Biotech/ Microbiology; M.Tech. Biotech/ PhD – Biotech

Age : 38 to 42 years

Experience : Over 15 years relevant experience of manufacturing / production including successfully running a Biological facility manufacturing vaccines in a reputed Company as site head.

Location of work : Lalru, Punjab

Job Summary

Role and Responsibilities:

Role: -- The position presents a great opportunity and challenge to manufacture vaccine drug substance at Drug Substance manufacturing Plant, Lalru with high quality standards. It provides the opportunity for leadership in adaptation of best practices and innovative thinking, combined with the need to ‘make things happen’ in tight time-frames, given the size and speed of the company’s growth trajectory.

Resolve all problems and issues arising in all departments ( Production, Utility & Maintenance, Animal House, IT,HR, Warehouse, SCM,MM, EOHS, Admin etc.) using his people, conceptual and technical skills to deliver quality products within timelines and budgets while complying with all regulatory and customer quality requirements in process of manufacturing.

Establish benchmarks in manufacturing processes and related areas on a sustainable basis.

Be a good role model of a leader so as to inspire people in their own leadership development

Ensure a healthy work environment where people are motivated to work, learn and grow and not stressed. This also means no politicization of environment will happen under his leadership

Zero Defect - Zero defects production, no quality Customer Complaints

Achieve set target top line & bottom-line

Responsibilities:

Financials

• To keep the budget under control and make sure that it does not go against the company’s standard practices.
• To involve in the annual business planning and budgeting of the manufacturing plant.
• To make short and long term plans in a bid to increase the efficiency and profitability of the plant.
• To organize and directing workflow for satisfying production requirement in a cost-efficient manner.
• Developing and motivating the cost-effective alternatives ad improvements to production process.
• Determining the future needs and production capacity for producing required quantities of items on pre-defined standards and within financial costs.

Customer

• Participate in regulatory audits as required
• Liaising with the product line manager on planning and predicting customer orders to satisfy shipments.
• Liaise with other functional/departmental managers so as to understand all necessary aspects and needs of operational development, and to ensure they are fully informed of operational objectives, purposes and achievements
• Liaising with respective departments and authorities for obtaining various approvals & clearances for seamless plant operations.
• Working in close coordination in work groups & supporting departments for conducting process audits and detailing on quality requirements and finalizing the quality plan.
• Establish and maintain appropriate systems for measuring necessary aspects of operational management and development
• Monitor measure and report on operational issues, opportunities and development plans and achievements within agreed formats and timescales.

Process

• Responsible for ensuring that the product being manufactured meets the company’s standards, policies and practices.
• Responsible for developing and implementing policies and procedures, formulating manufacturing operations strategies, building and mentoring manufacturing employees and driving business results. This includes ensuring the highest quality equipment, materials and production standards, overseeing, maintaining manufacturing budgets, working with employees, and purchasing staff to manufacture quality products that will meet customers' expectations in the most cost-effective manner.
• Should have thorough technical knowledge of products under manufacturing and to be manufactured in pipeline.
• Should be able to face all audits and lead them successfully.
• Drive continuous improvements to deliver manufacturing efficiencies and enhanced compliance standards
• Planning, directing, and coordinating the manufacturing of products in compliance with company goals and objectives.
• Plan, develop and implement strategy for operational management and development so as to meet agreed organisational performance plans within agreed budgets and timescales (covering relevant areas of operation - e.g. manufacturing, distribution, administration, whatever falls within remit according to organisation's structure)
• Directing the development and implementation of key procurement strategies / contingency plans and ensuring that strategies & plans are aligned with production requirements.
• Heading Warehouse, production operations with a view to ensure timely accomplishment of production targets within the time and cost parameters.
• Planning & implementing the preventive & predictive maintenance schedules for improving the overall reliability and safety of plant equipment’s
• Ensuring compliance of various quality measures such as cGLP/cGMP by maintenance of appropriate requisite documentation/ records.
• Identifying areas of improvement and recommending process modifications and equipment calibrations, validation to enhance operational efficiencies of machine / equipment.
• Using process, quality and production improvement methodologies, the site head of manufacturing directs the development, planning, implementation and maintenance of manufacturing methods for new or existing products and technologies. This includes outgoing quality, safety and efficiency improvements for all manufactured operations and compliance with safety, state and federal regulations
• Should have good supervising ability to monitor respective HODs and functions reported by
• Should ensure that workforce is well informed, disciplined, and knows the job to be done.

People & Information Technology

• Ensure adequate recruitment, training and staff development to maintain a highly motivated, skilled and efficient group to meet the needs of the business
• Provide supervision, mentoring and direction to direct reports, ensuring clear annual objectives for performance to be measured against, and hold regular support meetings to review progress
• Developing, directing, guiding, managing and monitoring the performance of multi-skilled large work force and conceptualizing need-based training programs for performing maintenance operations.
• Delegating work schedules for smooth functioning of operations & leading people working at all level in an organization.
• Training needs identification & evaluation of personnel training with the help of Training matrix.
• Maintaining Harmonious Industrial Relations at the Site level.
• Information Technology
• Establish and maintain appropriate systems for measuring necessary aspects of operational management and development.
• Monitor, measure and report on operational issues, opportunities and development plans and achievements within agreed formats and timescales

Technical Competencies required:

• Should have good technical understanding of manufacturing process , related areas and products (e.g. Should have implemented cold chain practices for effective transportation of goods)
• Should have demonstrated successful track record of having scaled a vaccine manufacturing set up with measurable impact on key performance metrics including but not limited to QMS, production yields, timelines, and cost efficiencies.
• Successful Experience in obtaining approvals from and dealing with International Regulatory Authorities particularly WHO PQ. Preferred but not essential is experience with USFDA, MHRA, TGA &/or other regulated markets
• Possesses the required skill sets and leadership for successful quality & GMP audits and establishing effective quality management systems
• Highly developed Quality understanding through experience of auditing, facing auditing along with production experience
• Troubleshooting of variety of problems that occur during production process (science base and risk assessment base approach)
• Manage Technical transfer issues for new products development
• Excellent GMP orientation

Behavioral Competencies Required :

• Very high in people and behavioral understanding so that he can lead and drive people (high EQ and IQ), Create a healthy work climate by encouraging OCTAPACE
• Ethically committed to Quality and strict no-no for shortcuts (Jugaads)
• Team player
• High Excellence drive
• Very high networking skills to maintain excellent relationships with external and internal stakeholders
• Self-empowered individual who proactively resolves issues
• Decision making
• Analyzing skills
• Problem solving

Interested Candidate may send their resume to Mr. Kulvinder Sarao, CHRO & Sr. Vice President at his email address