Responsibilities

1. Operations Management

- Lead a team of Supervisors, Operations Engineers and Biotechnologists to execute the following activities in accordance with the master production plan:

• VS Logistics: Preparation and supply of materials/buffers needed for manufacturing of intermediates and product

• Bulk/Coupling manufacturing processes: Manufacturing of intermediates & product

• Manufacturing Excellence: Active identification and implementation of improvements in the value stream

This includes:

• Managing all stages of process orders & batch records within  manufacturing.

• Resolve day-to-day or systemic constraints

- Actively work with Planning to identify short and long term constraints in meeting commercial demand and participate in addressing the constraints.

- Accountable for materials and inventory accuracy per material consumption policies and principles.

- Management of activities that impact manufacturing such as calibration/maintenance activities, validations, trials, development works and technical transfers.

- Optimise resource and capacity utilization in terms of

• Manpower

• Facility

• Equipment

• Process

2. Leadership

• Lead and motivate team members to achieve site objectives

• Perform regular gemba to engage the team and to understand shop floor issues

• Establish succession plan for the critical roles in team and perform regular review to manage the gaps

• Communicate effectively and engage cross-functional stakeholders to achieve site objectives collaboratively

3. Training & Development

• Ensure training and development of members in the team.

4. Quality

• Ensure quality of product by operating in compliance with GMP requirements

• Ensure deviation investigations are performed promptly and appropriate CAPAs being put in place to address the root causes.

5. Continuous Improvement

• Facilitate implementation of improvements to production workflows, systems and equipment.

• Embed use of DMAIC for problem solving

• Embed continuous improvement mindset in the team

6. EHSS

Establish and sustain a safe environment by

• operating in compliance with EHSS requirements.

• identifying and managing risks

• addressing all EHSS incidents, unsafe practices or non-compliance to regulations/standards in a timely manner

The VS manager role is also an EHSS standard owner aiming to ensure compliance with the corresponding requirements on site, by completing the respective gap assessment and remediations, as stated below:

• Coupling – Ergonomics

• Purified Bulk – Physical Risk

• VS Logistics – Waste Management

Knowledge, Skills & Experience

• University degree, in a relevant science or engineering discipline

• At least 8 years of experience in (bio)pharmaceutical industry.

• Proficient with extensive knowledge and hands-on experience of (bio)pharmaceutical manufacturing processes

• Good understanding of cGMP regulatory and legal requirements as applied to vaccines or biologics manufacturing

• Good knowledge of EHSS regulations/standards

• Strategic thinking (big picture perspectives) with a strong analytical thinking and logical grasp of facts

• Pragmatic with good grasp of reality of what is possible, yet with strong focus on continuous improvements including breakthroughs

• Ability to communicate effectively within the site organization and across the network, with good skills in people management, stakeholder engagement, risk management and change management

• Good project management skills