Head Site Operations

The incumbent will be responsible for managing the overall manufacturing operations for the organization involving multiple facilities. The incumbent will guide and lead members of the Operations team to deliver as per the corporate goals, projects, plans and timelines.
This position requires demonstrated ability to work effectively as both technical and people leader, manage tasks, resolve problems and issues and drive implementation/action plans to meet objectives along with excellent interpersonal and presentation skills.
A person in this role is expected to lead, troubleshoot, incorporate latest systems and processes along with applying innovative thinking to improve effectiveness and efficiency of the function.
The incumbent is expected to engage and interact frequently with cross functional teams, senior management, external partners/collaborators, and stakeholders.

QUALIFICATION:
Postgraduate or PhD degree in a relevant Science or Engineering field

EXPERIENCE:
20 or more years of experience in the GMP manufacturing/operations in vaccines and/or biologics industry
Demonstrated ability to manage entire GMP manufacturing operations with key focus on time bound delivery
and quality
Experience in single
use/disposable bio process equipment and technologies
Experience with regulatory inspections and inspection readiness
Experience in documentation and compilation of data for regulatory submissions (IND), i.e., transition from product development to commercial quality systems and operations
Thorough understanding and knowledge of global GMP regulations and requirements to support vaccines and biologics manufacturing for human use
Strong team player with demonstrated track record of success in a cross functional team and fast moving environment

Excellent organization and planning skills
Strong strategic thinking and problem solving skills
Ability to take responsibility and ownership along with capability to deliver/execute independently with minimal directions
Ability to integrate complex business considerations in formulating operations efficiency with a quality approach
Excellent cross functional and stakeholder management skills and ability to develop strong relationships across functions, senior leaders, and key stakeholders
Strong communication and interpersonal skills including ability to prepare and deliver effective presentations
and provide information to influence major decisions
Ability to work with computer controlled systems and proficient with Microsoft Word, Excel, and PowerPoint
Must have a positive attitude and be adaptable to a dynamic startup environment without losing focus on business goals

Key Roles/Responsibilities
Responsible for complete GMP operations from media and buffer preparation, upstream and downstream process to finished product for manufacturing of clinical material for vaccine and Biologic/bio therapeutic products for all Yapan Bio facilities (up to 1000L bioreactor scale).
Review Authority of SOPs, BMR, BPR etc.
Planning, execution, and documentation of all the activities related to the GMP operations as per the
global quality and regulatory compliance, including US FDA and EMEA
Implementation of quality systems with support of the Quality team of the organization
Execution of production batches/operations under GMP, complying to the Quality systems of the organization
Ensure optimal utilization of resources (facility, equipment, and manpower)
Ensure Audit readiness / compliance for the facility, equipment, and operations at all times
Coordinate with cross functional teams like QA, QC, HR, Supply Chain, Maintenance & Engineering to manage the daily operations smoothly
Ensure timely completion of calibrations and validations of the equipment and facility in coordination with QA and Maintenance & Engineering teams
Appropriate handling and closure of change controls, deviations, and investigations
Preparation and execution of the production plan as per the project requirements
Introduce new systems and procedures where appropriate
Manage, engage, and interact with the relevant stakeholders for preparation and presentation of data, reports, and documents in the relevant formats regularly
Remain current with the GMP trends. Review and interpret new regulations, and ensure that manufacturing department evolve accordingly
Recruit, train, grow and mentor members of the team as per the respective roles and job requirement
Guide and lead members of the team to deliver as per the corporate goals, projects, plans and timelines
Represent the manufacturing operations function both internally and externally
Prepare and manage department s operating plans and budget
Foster a safe and collaborative culture and work environment to ensure the team works together to reach their potential
Communicate openly and work to the highest levels of ethics, quality, and integrity

Piramal Success Factors
Thinks big
Contributing to strategic initiatives, generating and executing new ideas & Supporting team members to deal with change. Building & balancing long term and short term goals and translating strategy into action.

Commits and delivers results
Leading initiatives, developing plan for self/team, persistent and taking ownership to support business growth. Planning and mobilizing resources, Monitoring business results and tracking performance of team.

Collaborates
Facilitating collaborative work environment, prioritizing team goals, Building relationships across organization and consensus within team. Understanding group
dynamics and encouraging collaboration.

Serves Customers
Understanding and driving customer needs to deliver and manage customer expectations. Adding value and maintaining relationships beyond deliverables.
Identifying emerging customer needs and building feedback mechanism to address customer expectation.

Displays Humility
Treating team members with respect and dignity, being transparent and driving humility as core value. Acknowledging and accepting diverse opinions from team
members.

Empowers and develops
Providing regular feedback and understanding strengths and development areas of team members. Sharing expertise, encouraging others to take up responsibilities, building processes for continuous and timely feedback.