Head Site Operations

1 month ago

hyderabad, India Piramal Pharma Solutions Full time

Yapan Bio is a Biotechnology Company established to serve the rapidly expanding Custom Development and Manufacturing (CDMO) market for Vaccines and Biologics/Bio therapeutics. Yapan Bio has established state of the art facilities for process development and GMP manufacturing for human clinical studies, including both Drug Substance (DS) and Drug Product (DP), at Genome Valley in Hyderabad. The facility is built as per the quality and regulatory expectation of the global regulatory authorities. The facility includes Bio Safety Level 2+ (BSL 2+) suite to develop and manufacture high containment product classes. Yapan Bio is currently developing novel vaccines and biologics for the global innovative biotechnology companies.

We are looking for talented and experienced individuals, with can do attitude, who are self starters with excellent communications & leadership skills, who enjoy working on the details without losing sight of the larger organizational goals and are adaptable to a dynamic “startup” environment, to join our team. At Yapan Bio, you will get a supportive, collaborative, and empowering work environment to make a significant impact along with ownership as we drive the growth of the company together.


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 mABs gene therapy recombinant 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


EXPERIENCE:

•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

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