External Manufacturing Organization (EMO) - Manager/ Sr Manager

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    "html_title": "Kashiv Biosciences LLC - External Manufacturing Organization (EMO) - Manager/ Sr Manager",
    "description_html": "<p><strong>SUMMARY:</strong></p><p><br></p><p>The Manager of CMO Operations oversees outsourced production, technical transfers, and routine manufacturing activities across multiple contract manufacturing organizations to ensure reliable supply, regulatory compliance, and high-quality performance. You will coordinate between external partners and internal stakeholders across the CMC Lifecycle (Development, Clinical, MSAT, Operations, Regulatory, others) to drive our outsourcing product portfolio. This role will be the Single Point of Contact (SPOC) to our external partners for contract management, coordination, execution, and issues resolution. When needed you will act as the \"Person-in-Plant\", providing on the floor oversight of CMO facilities to ensure compliance with current Good Manufacturing Practices (cGMP) in collaboration with Quality and Technical teams.</p><p><br></p><p><strong>Essential Duties:</strong></p><p><br></p><p><strong>Executing for Results</strong></p><ul><li>The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.</li><li>Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.</li><li>A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.</li><li>A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.</li></ul><p><br></p><p><strong>Leadership and Stakeholders</strong></p><ul><li>The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from colleagues and partners.</li><li>High emotional intelligence (EQ) to recognize time to de-escalate tension, find solutions which incorporate team’s insight, smooth egos, and maintain professionalism to advance our goals.</li><li>A leader who is self-reflective and aware of their own limitations; leads by example and drives performance with an attitude of continuous improvement by being open to feedback and self-improvement.</li></ul><p><br></p><p><strong>Relationships and Influence</strong></p><ul><li>Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.</li><li>An ability to inspire trust and followership in others through compelling influence, passion in their beliefs, and active drive.</li><li>Encourages others to share the spotlight and visibly celebrates and supports the success of the team.</li><li>Creates a sense of purpose and meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.</li></ul><p><br></p><p><strong>Additional Responsibilities</strong></p><ul><li>Manage day-to-day operations with assigned CMOs, ensuring alignment with production schedules and business objectives</li><li>Build and maintain strong, collaborative relationships with external partners</li><li>Lead regular business reviews and performance discussions</li><li>Ensure timely production, release, and delivery of drug substances and/or drug products</li><li>Monitor manufacturing performance metrics (e.g., yield, deviations, on-time delivery)</li><li>Partner with Supply Chain to support demand planning and inventory management</li><li>Ensure all manufacturing activities comply with GMP and global regulatory requirements</li><li>Support investigations, deviations, CAPAs, and change controls in collaboration with Quality teams</li><li>Participate in audits and regulatory inspections as needed</li><li>Provide oversight for tech transfer, process validation, and lifecycle management</li><li>Collaborate with MSAT teams on process improvements</li><li>Troubleshoot manufacturing issues and drive resolution with CMOs</li><li>Lead cross-functional initiatives related to external manufacturing</li><li>Track milestones, risks, and deliverables for CMO-related projects</li><li>Ensure effective communication across internal teams (Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&amp;D)</li><li>Identify opportunities to optimize cost, efficiency, and quality</li><li>Implement best practices and operational improvements across CMO network</li></ul>",
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      "description": "<p>Description</p><p><strong>SUMMARY:</strong></p><p><br/></p><p>The Manager of CMO Operations oversees outsourced production, technical transfers, and routine manufacturing activities across multiple contract manufacturing organizations to ensure reliable supply, regulatory compliance, and high-quality performance. You will coordinate between external partners and internal stakeholders across the CMC Lifecycle (Development, Clinical, MSAT, Operations, Regulatory, others) to drive our outsourcing product portfolio. This role will be the Single Point of Contact (SPOC) to our external partners for contract management, coordination, execution, and issues resolution. When needed you will act as the \"Person-in-Plant\", providing on the floor oversight of CMO facilities to ensure compliance with current Good Manufacturing Practices (cGMP) in collaboration with Quality and Technical teams.</p><p><br/></p><p><strong>Essential Duties:</strong></p><p><br/></p><p><strong>Executing for Results</strong></p><ul><li>The ability to set clear and challenging goals while committing the organization to improved performance; tenacious and accountable in driving results.</li><li>Comfortable with ambiguity and uncertainty; the ability to adapt nimbly and lead others through complex situations.</li><li>A risk-taker who seeks data and input from others to foresee possible threats or unintended circumstances from decisions; someone who takes smart risks.</li><li>A leader who is viewed by others as having a high degree of integrity and forethought in their approach to making decisions; the ability to act in a transparent and consistent manner while always considering what is best for the organization.</li></ul><p><br/></p><p><strong>Leadership and Stakeholders</strong></p><ul><li>The ability to persevere in the face of challenges and exhibit a steadfast resolve and relentless commitment to higher standards, which commands respect from colleagues and partners.</li><li>High emotional intelligence (EQ) to recognize time to de-escalate tension, find solutions which incorporate team’s insight, smooth egos, and maintain professionalism to advance our goals.</li><li>A leader who is self-reflective and aware of their own limitations; leads by example and drives performance with an attitude of continuous improvement by being open to feedback and self-improvement.</li></ul><p><br/></p><p><strong>Relationships and Influence</strong></p><ul><li>Naturally connects and builds strong relationships with others, demonstrating strong emotional intelligence and an ability to communicate clearly and persuasively.</li><li>An ability to inspire trust and followership in others through compelling influence, passion in their beliefs, and active drive.</li><li>Encourages others to share the spotlight and visibly celebrates and supports the success of the team.</li><li>Creates a sense of purpose and meaning for the team that generates followership beyond their own personality and engages others to the greater purpose for the organization as a whole.</li></ul><p><br/></p><p><strong>Additional Responsibilities</strong></p><ul><li>Manage day-to-day operations with assigned CMOs, ensuring alignment with production schedules and business objectives</li><li>Build and maintain strong, collaborative relationships with external partners</li><li>Lead regular business reviews and performance discussions</li><li>Ensure timely production, release, and delivery of drug substances and/or drug products</li><li>Monitor manufacturing performance metrics (e.g., yield, deviations, on-time delivery)</li><li>Partner with Supply Chain to support demand planning and inventory management</li><li>Ensure all manufacturing activities comply with GMP and global regulatory requirements</li><li>Support investigations, deviations, CAPAs, and change controls in collaboration with Quality teams</li><li>Participate in audits and regulatory inspections as needed</li><li>Provide oversight for tech transfer, process validation, and lifecycle management</li><li>Collaborate with MSAT teams on process improvements</li><li>Troubleshoot manufacturing issues and drive resolution with CMOs</li><li>Lead cross-functional initiatives related to external manufacturing</li><li>Track milestones, risks, and deliverables for CMO-related projects</li><li>Ensure effective communication across internal teams (Manufacturing, Quality, Regulatory, Supply Chain, MSAT, R&D)</li><li>Identify opportunities to optimize cost, efficiency, and quality</li><li>Implement best practices and operational improvements across CMO network</li></ul><p>Requirements</p><p><strong>REQUIREMENTS:</strong>  </p><ul><li>Bachelor’s degree in engineering, life sciences, or related field. Preference given to advanced degrees (e.g., MS, MBA or PhD in similar fields).</li><li>10+ years of experience in biomanufacturing or regulated life sciences operations</li><li>8+ years of experience in GMP environment</li><li>Proven leadership experience managing muti-site CMO organization</li><li>Working knowledge of biomolecules manufacturing (e.g., cell culture, purification, fill-finish)</li><li>Experience scaling operations and expanding manufacturing capacity</li><li>Ability to collaborate within a matrixed organization</li><li>Track record of success partnership roles, influencing up and down the organization, driving cultural transformation and operational excellence</li><li>Mentoring, coaching and teaching ability and orientation</li><li>People development, performance management and change management are necessary skills for success</li><li>Financial metrics and acumen pertaining to site performance</li></ul><p><br/></p><p><strong>WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:</strong></p><ul><li><strong>General Work Environment:  </strong>Office and Operational facilities</li><li><strong>Noise</strong>: No extraordinary noise levels.</li><li><strong>Standing/Lifting</strong>: Must be able to move around the facility to reach various equipment; and lift at least 25lbs.</li><li><strong>Visual</strong>: No extraordinary requirements.</li><li><strong>Stress</strong>:  High-paced demanding environment to meet ambitious project goals.</li><li><strong>Travel</strong>:  Occasional Travel. </li></ul><p><u><strong>Supervisory Responsibility, if any</strong></u><strong>: </strong>dependent on company growth</p><p><br/></p><p><em><strong>This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.</strong></em></p>",
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