Sr. Alliance Manager, External Manufacturing

Summary of Position

The Senior Alliance Manager will be responsible for the management of the GEN-003 Herpes Vaccine Program within the External Manufacturing group as part of Pharmaceutical Sciences.  This individual will work closely with internal stakeholders and our external suppliers to ensure the development and implementation of robust development and manufacturing plans and strategies, tracking progress against plans and program goals, as well as effective communication across all internal stakeholders.   The ideal candidate will have a strong scientific and operations background and extensive experience working with external suppliers on biopharmaceutical and/or vaccine programs.   He/she will have experience managing cross-functional teams across organizations.  Several key areas of focus will be planning and management, execution monitoring and budget in alignment with department goals, inventory management and logistics.  The role also requires the ability to identify and communicate business risk to stakeholders and identify mitigation strategies. This individual will be a key player in meeting Genocea’s objectives and ensuring the success of our Herpes Vaccine program.   Hands on experience in vaccines and/or biopharmaceutical development and manufacturing is required.

 

Responsibilities

  • Manage cross-functional and cross-organization project teams, in partnership with project managers from our external suppliers to ensure delivery of cell bank, virus stock, drug substance, drug product, and adjuvant to meet the needs of our Herpes Vaccine program.
  • Provide leadership, coordination, and cross-functional communication to enable the team to meet the program goals
    • Meet with stakeholders, coordinate consensus, prepare plan, obtain management approval
    • Identify and track critical path activities
    • Budgeting: contribute to budget preparation, review of program contracts, review and approve invoices, provide routine updates to the Finance group.
    • Schedule and conduct regular project meetings as well as periodic project reviews
    • Assist in risk mitigation and communication to management and key stakeholders
    • Create and maintain comprehensive project documentation (e.g. Minutes, Dashboards)
  • Facilitate internal decision-making processes and provide regular updates to senior management.
  • Implement program management tools and templates to facilitate effective planning and communication (planning agendas, scheduling meetings, preparing minutes, and following-up with team members on critical action items)
  • Maintain program-related documentation (including the MS project plan, decision log, and risk register) and ensure appropriate archiving and access to shared information and critical program documents
  • Maintain inventory of cGMP and other key materials that require controlled storage. This includes material that is stored at our external suppliers.  Manages the shipment of material from our manufacturing locations to the distribution sites.  This includes customs documentation, cold chain management, and insurance.
  • Coordinates development and approval of packaging and labelling materials working with internal stakeholders and third party suppliers.

 

Desired Skills and Experience

  • MS degree in life sciences or a related field is required.
  • A minimum of 10 years with a combination of process development, operations and project management experience in biopharmaceuticals or vaccines.
  • Drug development experience is required.
  • Technology transfer experience is required.
  • Experience managing external vendors and consultants.
  • Strong understanding and competency in planning processes and decision making
  • Strong problem solving skills and an attention to detail
  • Strong presentation skills for both internal and external audiences
  • Highly motivated and a strong team player with the ability to handle multiple priorities in a fast-paced environment
  • Strong analytical and technology skills, including proficiency in project planning tools, MS project scheduling, and the Microsoft Office Suite
  • Experience with supply planning tools and templates is preferred.
  • Budget building and tracking skills
  • Ability to influence without direct authority
  • PMP Certification is preferred

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