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Piramal Enterprises

Head Site Operations

 Location : Hyderabad, Telangana, India

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Job Description

Business: Yapan Bio
Department: Manufacturing
Location: Genome Valley , Hyderabad , India
Travel: Moderate

Job Overview

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.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
 
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
 
Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
 
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Piramal Enterprises

Source : Piramal Enterprises Company website

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