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Senior Manager, Contract Development and Manufacturing Operations

Company: CSL Behring
Location: King Of Prussia
Posted on: November 22, 2021

Job Description:

Job DescriptionJob Purpose Manage and have oversight of 3rd party CDMOs supporting development and manufacturing of clinical products for Recombinant Product Development, Cell and Gene product development and Plasma Product Development areas within CSL Behring R&D. Main Responsibilities and Accountabilities:1. Lead selection of CDMOs in line with project strategies, defined business targets, technical requirements, and current procurement guidelines and processes

  • Manages, secures, and coordinates communication channels to assure SME and functional group alignment with regards to technical project deliverables and procurement/sourcing guidelines
  • In collaboration with requisite SMEs (PPD/RGPD/ESQA/ESI/Legal/Procurement/etc.) develops, negotiates MSAs/ SOWs and manages project execution2. Business Management oversight of CDMO process development & clinical manufacturing and related tasks, in support of PPD and RGPD areas
    • Balance internal and external needs; Advocating CSL needs to the CDMO and CDMO needs to CSL to assure mutual success.
    • Identification and escalation of projects risks and mitigation strategies via joint project team meetings with CDMO/CRO3. Manages communications both internally and externally within the business to deliver proposals, solutions, and mitigate conflict that will drive corporate goals.
      • Develops and executes communication and escalation strategies as appropriate
      • Relays CSL Strategy for long term alignment with internal functions
      • Work with Execution Teams and to ensure CDMO/CRO contractual requirements for on-time in full delivery of clinical products are met, while fostering a culture of mutual accountability and trust4. Responsible for management, issue resolution and escalation and prioritization of CDMO/CRO activities while meeting internal guidelines including but not limited to leading Joint Steering Committees, developing, tracking and reporting against KPIs for assigned partners.5. Manages associated budgets and CDMO Spend, including PO generation and has oversight of related invoicingPosition Qualifications and Experience Requirements: EducationMSc in Biochemistry/Biology/Chemistry, (Bio)chemical EngineeringExperience
        • 7 years of experience in biotechnological process development (multiple disciplines preferred) and or cGMP manufacturing, with direct experience leading global, cross functional teams.
        • 3 years' experience managing CDMOs for the development and/or manufacture of biotechnological development of therapeutic proteins, gene therapy, and/or small molecules.
        • Previous experience in tech transfer, management and/or oversight of manufacturing processes for cGMP Drug Product sterile filling and related analytical testing.
        • Experience negotiating clinical and or commercial manufacturing agreements.CompetenciesOrganizational Skills
          • Can multi-task and is able to prioritize conflicting demands. Is able to marshall or influence resources (people, funding, material and support) to get things done.
          • The ability to grasp new concepts quickly and to assimilate data from new sources
          • Ability to coordinate across cultures, time zones, and locations
          • Ability to proactively plan and execute on assigned projects. Can anticipate and adjust plans as required to achieve priorities. Communication skills:
            • Ability to communicate to meet the needs of the business
            • Ability to manage complexity and integrate regulatory requirements into CDMO deliverables
            • Recognizes confidential information and can manage the information accordingly
            • Excellent written and spoken communication skills (in English)
            • Can concisely provide the information people need to do their jobs and in a timely fashion.Energy and drive
              • Has the ability to steadfastly push self and others for results. Can be depended on achieving results.
              • Has perseverance, will pursue tasks with energy, drive and personal commitment to meet deliverables.Personal and interpersonal
                • Is customer focused.
                • Comfortable in exerting influence on cross -functional teams at multiple management levels.
                • Culturally sensitive. Can work across cultures and incorporate culturally appropriate communication styles into routine activities.
                • Demonstrates integrity and is trusted. Is able to maintain confidential information and admits mistakes.
                • Builds effective and constructive relationships, can utilize diplomacy and tact to comfortably diffuse conflict situations.
                • Maintains composure when under pressure and is able to handle stress without demonstration of frustration when challenges arise. Proposes solutions to challenges and drives for results.
                • Is an active and attentive listener and can accurately restate the opinions of others even when he/she disagrees.
                • Develops and maintains good peer relationships.About UsOur BenefitsWe encourage you to make your well-being a priority. It's important and so are you. Learn more about how we care at CSL.About CSL BehringCSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .We want CSL to reflect the world around usAs a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.Do work that matters at CSL Behring!

Keywords: CSL Behring, Philadelphia , Senior Manager, Contract Development and Manufacturing Operations, Executive , King Of Prussia, Pennsylvania

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