lavori da Manufacturing in località United States

VP Manufacturing Science and Technology will lead the strategic and operational direction of the Manufacturing Science and Technology (MS&T) organization across all manufacturing sites globally. This leader will ensure the development, optimization, and implementation of robust manufacturing processes to consistently deliver high-quality pharmaceutical products.

Key Responsibilities:

1. Strategic Leadership:

1. Develop and execute the strategy for the MS&T function aligned with the company’s business objectives and operational goals.
2. Establish a culture of innovation, quality, and efficiency within the MS&T organization.
3. Drive the adoption of advanced technologies, such as continuous manufacturing, digital transformation, and predictive analytics.
4. Act as a key member of the senior leadership team, contributing to the overall manufacturing and supply chain strategy.
5. Coordinate with local MS&T teams to ensure consistency and compliance with global standards.

2. Operational Excellence:

1. Oversee the global technology transfer of products, ensuring seamless scale-up, validation, and commercialization.
2. Ensure robust and reliable manufacturing processes are in place, minimizing variability and optimizing efficiency.
3. Lead the process validation lifecycle, ensuring compliance with global regulatory requirements.
4. Drive continuous improvement initiatives to enhance productivity, reduce costs, and improve product quality.
5. Provide technical leadership in troubleshooting and resolving complex manufacturing issues.

3. Collaboration and Cross-Functional Leadership:

1. Partner with Quality, Regulatory, and Supply Chain teams to ensure alignment on product and process requirements.
2. Act as a key liaison with regulatory authorities during audits, inspections, and submissions related to manufacturing processes.
3. Collaborate with Analytical Science & Technology (AS&T) to ensure analytical methods are aligned with process requirements.
4. Manage relationships with external partners, including contract manufacturing organizations (CMOs), to ensure technical alignment and process consistency.

4. Talent and Team Development:

1. Build and lead a high-performing MS&T team, ensuring the development and retention of top talent.
2. Foster a culture of technical excellence, accountability, and continuous learning.
3. Provide coaching and mentorship to MS&T leaders and teams at the site and regional levels.

5. Compliance and Governance:

1. Lead the MS&T governance, guidance and processes are harmonized and applied across the company.
2. Ensure functional support to local MS&T organization aligned with regional office.
3. Manage MS&T related budgets FTE, OPEX.
4. Role model Arcera Values and adhere to the internal policies and standard operating procedures designed to ensure patient safety, including mandatory attendance at trainings.

Key Skills:

1. Strategic Thinking: Ability to set a long-term strategic vision while executing immediate priorities.
2. Change Management: Proficiency in leading organizational change and foster a culture centered on quality and compliance, and ensuring employee engagement.
3. Decision-making under pressure: make high impact decisions in complex and ambiguous situations.
4. Business Acumen: Understanding of the pharmaceutical industry landscape, regulatory requirements, that drive sustainable growth and competitive advantage.
5. People leadership: Developing leadership pipelines and fostering a strong organizational culture.
6. Organizational savviness: Expert at navigating complex corporate structures, building strong cross-functional relationships and influencing key stakeholders to align strategies with business objectives.
7. End-to-End Global Network Transformation & Optimization: Proven expertise in designing and leading the transformation of fully integrated global networks, encompassing manufacturing, quality, supply chain, digital, and B2B operations. Adept at driving network optimization through data-driven decision-making, advanced digital technologies, and strategic partnerships. Skilled in fostering a transformation mindset, enhancing agility, and aligning regional and global operations to improve efficiency, resilience, and business performance.
8. Excellent problem-solving skills and ability to lead cross-functional teams in resolving complex issues.
9. Expertise in continuous improvement methodologies, such as Lean, Six Sigma, or Operational Excellence.

Qualifications & Experience:

1. Advanced degree (Master’s or PhD) in Engineering, Pharmaceutical Sciences, Chemistry, Biotechnology, or a related field.
2. Minimum of 15 years of experience in pharmaceutical manufacturing, technical operations, or MS&T.
3. Proven track record of leading global teams and managing complex technical challenges.
4. Extensive experience in technology transfer, process validation, and commercial manufacturing.
5. Strong knowledge of global regulatory requirements (e.g., FDA, EMA, ICH guidelines).
6. Demonstrated success in implementing advanced manufacturing technologies and driving innovation.
7. Fluent English, an additional language desirable.