ED/VP Commercial CMC Europe

Job Title:Vice President Europe Commercial CMC

Location: Basel Germany

WuXi Biologicsis a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover develop and manufacture biologics from concept to commercial manufacturing. WuXi Biologics achievements are a direct result of the efforts made by our employees. We have built an extraordinary team motivated by ourPROUDcultureof Passion Reward Opportunity Unity and Determination.WuXi Biologicsoffers excitingjobopportunitiesandcareersaround the globe. We currently employ over 12000 people and provide services to more than 600 customers worldwide including all the top 20biopharmaceuticalcompanies

Job Summary:

A unique opportunity is reporting to the SVP Head of Global CMC who will lead the commercial CMC Teams (PPQ BLA Launch Commercial Manufacturing) for the European customer base. This role will oversee the strategic and operational aspects of CMC to ensure the successful commercial development validation and commercialization of large molecules all while ensuring regulatory compliance and industry standards are met. This role demands strong CMO and external contract manufacturing management experience along with a background in Late Stage/Commercial development and commercialization of biologics in Large Pharma and proven leadership in managing matrixed teams.

Responsibilities:

• Leadership & Team Development:

Lead mentor and develop the commercial CMC teams driving initiatives that align with the companys vision and mission. Inspire a culture of collaboration accountability and high performance. Establish strong collaboration with global Manufacturing to ensure the success of CMC teams for the validation launch and commercialization of biologics. Accountable for the overall commercial portfolio of CMC projects for the North America client base.

• Client Relationship and Key Account Management:

Build and sustain long-term client relationships by understanding client needs tailoring services maintaining open communication and consistently exceeding expectations.

• Business Strategy & Development:

Formulate and implement strategies across various business models integrated solutions market-specific approaches and client insight analysis.

• Late Stage/Commercial Technical Capability Portfolio:

Spearhead the design and execution of process validation process performance qualification and commercial manufacturing ensuring the integration of CMC into broader company objectives.

• CMC Strategy & Execution:

Develop and lead commercial CMC strategies for commercial supply ensuring alignment with corporate goals and regulatory requirements.

• CDMO Management:

Establish guidelines select and manage CDMOs for efficient and cost-effective project execution. This includes contract negotiations project management and performance evaluation.

• GMP Manufacturing & Process Scaling:

Oversee the enhancement and scaling of GMP manufacturing processes ensuring they meet clinical and commercial supply needs while maintaining product quality and regulatory compliance.

• Cross-functional Collaboration:

Work closely with senior leadership and cross-functional teams to integrate CMC considerations into comprehensive product development plans. Identify risks proactively and implement mitigation strategies.

• Continuous Improvement & Excellence:
• Drive efforts to enhance excellence streamline project progression and ensure efficient CMC development stages.
• Industry Trends & Best Practices:

Stay updated on emerging trends technologies and best practices in CMC development to guide informed decision-making and strategic planning.

• Regulatory Liaison:

Serve as the companys liaison with regulatory agencies providing CMC expertise and support during regulatory submissions inspections and responding to inquiries.

Qualifications:

• Educational Background:

Degree in Chemistry Chemical/Biochemical Engineering Pharmaceutical Sciences or a related discipline. PhD is strongly preferred but not required.

• Experience:

Extensive experience (ideally 15 years) in Large Pharma and CMOs is critical with a strong background in CMO/external contract manufacturing. Proven track record managing large molecules supply chain and contractor management.

• Technical Proficiency:

Deep technical knowledge in CMC development and manufacturing with the ability to advance clinical programs and achieve commercialization.

• Regulatory Expertise:

Thorough understanding of regulatory standards and guidelines governing CMC activities within pharmaceutical product development.

• Leadership & Collaboration:

Proven experience leading cross-functional teams with excellent communication and interpersonal skills. Demonstrated ability to collaborate effectively with senior leadership and external partners.

• Strategic Mindset:

Strong strategic thinking skills with a track record of solving complex challenges and delivering results in a fast-paced environment.

WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin or protected veteran status and will not be discriminated against on the basis of disability