MFG Production Head

WuXi Biologics; Wuppertal; Vor Ort; EUR 80.000 - 100.000; Vollzeit

Zusammenfassung

A global biopharmaceutical company located in Wuppertal is seeking a Manufacturing Production Head to oversee all aspects of manufacturing strategy, ensuring alignment with operations and compliance standards. This role demands leadership in developing production plans, interfacing with regulatory bodies, and cultivating a high-performance culture focused on continuous improvement. The ideal candidate will have over 10 years of experience in biological manufacturing and command of English and German. This position offers an opportunity to influence business strategy and drive operational success.

Qualifikationen

• 10+ years in Biologicals Manufacturing and Operations Management.
• Strong understanding of cGMP and GMP-compliant operations.
• Fluent in English and German, both written and spoken.

Aufgaben

• Lead the development and implementation of site production plans.
• Interface with Regulatory bodies for inspections.
• Foster a culture of continuous improvement.

Kenntnisse

Leadership

Change Management

Analytical Skills

Biologics Operations

Strategic Decision Making

Communication

Ausbildung

Master/Diploma in Biotechnology or related field

PhD advantageous

MBA advantageous

Jobbeschreibung

Overview

Manufacturing Production Head - MFG 19. Reporting to the Site Head. Responsible for all aspects of the manufacturing strategy design, scale-up and sustaining. The role will ensure alignment of all Manufacturing functional areas including Upstream & Downstream processing, Manufacturing Technology, Maintenance, Operational Readiness. Working closely with internal stakeholders in Wuppertal and China, the role is responsible for ensuring the successful scale-up of the manufacturing team to meet the start-up schedule. The role provides leadership across all site manufacturing activities to achieve site KPIs when sustaining. Developing key relationships with external stakeholders and customers is critical to achieve business goals and long-term strategy.

Essential Duties and Responsibilities

1. • Lead the development and implementation of site production plans to achieve forecasted goals and strategic objectives. Provide direction to the Manufacturing team to meet customer service requirements within defined timelines.
   • Extensive liaison with WuXi Biologics corporate counterparts to professionally represent the local site Manufacturing organization.
   • Develop the overall Manufacturing strategy aligned with the facility’s strategic business plans and global Manufacturing strategy.
   • Collaborate with the Wuppertal Site Head and relevant colleagues to develop and implement strategic objectives for the Manufacturing team.
   • Provide leadership for all site production activities during construction and beyond (safety, supply planning, quality, cost, inventory, resource allocation, and prioritization).

Identify and manage activities to maintain safety, supply planning, quality, cost, inventory and stock management, resource allocation, and reprioritization as needed.

1. • Interface management between the Wuppertal site and WuXi corporate Manufacturing team to ensure alignment with wider corporate objectives.
   • As a CMC leader, interact with internal teams and external clients to meet project goals, respond to urgent manufacturing events, and provide solutions for on-time delivery.

Leadership and People Development

1. • Build and develop a high-performing manufacturing management team, including attraction, development, and retention of talent.
   • Measure Manufacturing team performance against KPIs with Site Head and HR; drive engagement in Learning and Development and performance management.
   • Foster a culture of continuous improvement, recognition, and constructive feedback.
   • Identify and drive opportunities for optimal, cost-effective productivity.
   • Provide guidance to achieve customer service requirements within defined timelines.
   • Collaborate with the leadership team to plan future capacity in line with strategic objectives, cost efficiencies, and new business opportunities.
   • Ensure processes enable resource allocation and reprioritization of production activities as needed.
   • Lead cost-improvement initiatives and outsourcing of production steps as required.
   • Ensure efficient and safe execution of site production plans and drive process robustness to reduce deviations.
   • Develop strategies to manage supplier relationships and ensure raw material stock levels align with supply chain planning and safety best practices.
   • Lead the Manufacturing team to minimize working capital and drive lean cGMP manufacturing practices where possible without compromising quality and delivery.
   • Provide direction on complex compliance issues and ensure operations meet regulatory, quality and safety standards.
   • Interface with Regulatory bodies as required, representing the site to authorities and inspectors on production management, quality, safety and risk.
   • Adhere to safety and quality standards relevant to Manufacturing, driving continuous improvement in equipment and site safety.
   • Be flexible to take on additional tasks as directed by the Site Head and act as a role model for WuXi corporate values.

Driving Strategy, Vision & Business

1. • Create and implement best-practice manufacturing vision, strategy, processes and procedures to improve business performance.
   • Develop and execute the site’s strategic plan aligned with company goals and objectives.
   • Collaborate with DS sites in the global Manufacturing Network and other global functions to ensure alignment across capacity and technology.
   • Establish strategy and best practices for staff to achieve overall business objectives.
   • Engage with Business Development, Project Management and clients to understand needs, address challenges, and ensure project execution.
   • Maintain strong relationships with key clients to foster long-term partnerships.

Quality, Compliance and EHS

1. • Uphold high standards of quality and compliance, ensuring manufacturing processes meet regulatory requirements (cGMP, FDA, EMA, etc.).

Quality and Safety Governance

1. • Ensure the site is inspection-ready and acts as site representative during inspections and audits.
   • Operate in accordance with health, safety and environmental policies to ensure staff and visitor safety and wellbeing.
   • Act as a role model and enabler of quality and safety culture.

Leadership and People Development (Continued)

1. • Provide visionary leadership fostering collaboration, openness, innovation, and continuous improvement.
   • Set high targets and coach/mentor direct reports to enable a high-performing team.
   • Model WuXi corporate values and local site commitments.
   • Promote a culture of high performance and continuous improvement with strong cross-team communication.
   • Build a winning team spirit, collaborating with Quality Assurance, Regulatory Affairs, Supply Chain and R&D.

Person Specification

1. • Excellent leadership and people management skills.
   • Strong conceptual thinking with presentation and representation skills.
   • Entrepreneurial mindset and strategic thinking to develop a vision and roadmap for the drug substance sites organization and WuXi Biologics Germany strategy.
   • Strong background in Mammalian Cell Culture-based Biologics Operations and Industrialization Management.
   • Understanding of corporate governance and compliance and organization design.
   • Proficiency in Lean Management and/or Operational Excellence desired.
   • Excellent command of German and English, both written and spoken.

Experience

1. • More than 10 years in Biologicals Manufacturing and/or Operations Management with exposure to key role requirements.
   • Strong understanding of cGMPs and leading GMP-compliant operations with regulatory interaction.
   • Site leadership experience driving cross-functional team performance.
   • Proficiency in planning, alignment, and effective communication.
   • Experience with startup operations and CapEx projects.
   • Strategic, budgeting and reporting experience; multinational contract manufacturing familiarity is advantageous.
   • Experience in presenting business cases and strategy to senior leaders; international best practices desired.

Qualifications

1. • Master/Diploma degree and above in Biotechnology, Biochemistry, Biology, etc.
   • PhD in Biotechnology, Process Engineering or related field advantageous but not required.
   • MBA or pharma business qualification advantageous but not required.

Behavioural Competencies

1. • Strong leadership ownership and a passion for results in manufacturing management.
   • Proven track record in people leadership, change management and startup scenarios.
   • Excellent analytical and project management skills; ability to handle multiple projects.
   • Strong strategic decision-making, business acumen and negotiation skills.
   • Excellent interpersonal and communication skills; problem solver with a continuous improvement mindset.

As we extend our global reach, we need colleagues interested in change, challenge, and building a new future together. Reach beyond yourself and discover your potential. Apply now.

WuXi Biologics is an equal opportunities employer. For more information before you apply please visit us at

Key Skills: J2se, Counselling, B2C, Account Management, Document Control Management

Employment Type : Full Time

Experience: years

Vacancy: 1