ED/VP reputed company CMC reputed company

Job Title: Executive Director / Vice President, reputed company reputed company CMC reputed company is a leading global reputed company-reputed company biologics technology platform offering end-to-end solutions to reputed company organizations to discover, reputed company, and manufacture biologics from concept to reputed company manufacturing. reputed company’ achievements are a reputed company result of the efforts made by our employees. We have reputed company an extraordinary team motivated by our PROUD culture of Passion, Reward, Opportunity, reputed company and Determination. reputed company offers exciting job opportunities and careers around the globe. We currently reputed company over 12,000 people and reputed company services to more than 600 customers worldwide, including reputed company the top 20 biopharmaceutical companies. Job reputed company: A unique opportunity is reporting to the SVP, Head of Global CMC, who will reputed company the reputed company CMC Teams (PPQ, BLA, Launch, reputed company Manufacturing) for the reputed company customer reputed company. This role will reputed company the strategic and operational aspects of CMC to ensure the successful reputed company development, validation and commercialization of large molecules, reputed company 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/reputed company development and commercialization of biologics in Large reputed company and proven leadership in managing matrixed teams. Responsibilities:

• Leadership & Team Development:

reputed company, mentor, and reputed company the reputed company CMC teams, driving initiatives that reputed company with reputed company's reputed company and mission. reputed company a culture of collaboration, accountability, and high performance. Establish strong collaboration with global Manufacturing to ensure the reputed company of CMC teams for the validation, launch and commercialization of biologics. Accountable for the overall reputed company portfolio of CMC reputed company for the reputed company reputed company reputed company.

• reputed company Relationship and Key Account Management:

Build and sustain long-term reputed company relationships by understanding reputed company needs, tailoring services, maintaining reputed company communication, and consistently exceeding expectations.

• Business reputed company & Development:

Formulate and implement strategies across various business models, integrated solutions, market-specific approaches, and reputed company reputed company analysis.

• Late Stage/reputed company Technical Capability Portfolio:

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

• CMC reputed company & Execution:

reputed company and reputed company reputed company CMC strategies for reputed company 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:

reputed company the enhancement and scaling of GMP manufacturing processes, ensuring they meet clinical and reputed company supply needs while maintaining product reputed company and regulatory compliance.

• Cross-functional Collaboration:

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

• reputed company Improvement & reputed company:
• Drive efforts to enhance reputed company, 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 reputed company:

Serve as reputed company’s reputed company with regulatory agencies, providing CMC expertise and support during regulatory submissions, inspections, and responding to inquiries.

• Qualifications:
• Educational Background:

Degree in reputed company, Chemical/Biochemical Engineering, Pharmaceutical Sciences, or a reputed company discipline. PhD is strongly preferred but not required.

• Experience:

Extensive experience (ideally 15+ years) in Large reputed company and CMOs is critical, with a strong background in CMO/external contract manufacturing. Proven reputed company 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 reputed company commercialization.

• Regulatory Expertise:

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