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Position Brand Description:
The Senior Director - Portfolio Management is primarily responsible for facilitating and managing the development and implementation of an integrated technical agenda for commercially manufactured Peptide molecules. The position is responsible for influencing the organization around project selection and strategies for these Peptide molecules. In addition, the Advisor ensures development of integrated technical agendas for the portfolio of E. coli products and leads cross functional manufacturing/quality peer and senior management teams for Peptide and E. coli portfolio management oversight. Broader project-based support for other non-E. coli molecules may also be needed at times. A person in this position has a CM&C and/or Manufacturing background and is expected to apply project and portfolio management principles as guided by PMBOK, provide strategic decision-making leadership for cross functional teams and participate in process improvement activities within manufacturing. This position will be responsible for leading and managing large scale projects/programs with significant risk and complexity to achieve critical business objectives.
- Lead Global Post-Launch Optimization Team(s) (GPLOT) to ensure that the deliverables and expectations are met. This includes development and management of a strategic integrated technical agenda, facilitating discussion of routine performance monitoring, APR and GPA reviews to ensure the processes are in control and capable.
- Serve as network liaison for GPLOT technical agendas and/or networks forums.
Effectively manage upward and cross-function communications, particularly with the members of the Business Unit, key manufacturing functions, and senior manufacturing/quality management.
- Lead Peptide and E. coli Regulatory Steering Teams to provide early awareness of proposed changes and ensure initial regulatory assessments prior to potential project initiation.
- Lead E. coli Technical Agenda Hub (EcTAH) team in tactical oversight of the technical agenda, including integration of technical project, regulatory and supply chain activities. Lead team in evaluation of integration impact due to new projects entering the portfolio and project milestone delays for existing projects.
- Lead key meetings with senior Manufacturing & Quality management in strategic oversight of any Peptide or E. coli technical agenda portfolio issues. Ensure escalation and effective communication of project management issues, risks, and integration recommendations.
- Proactively monitor emerging technical, regulatory, and supply chain environment issues and develop scenarios for addressing risks.
- Influence internal and external customers/partners to identify opportunities for improving technologies, processes, and products.
- Build and maintain effective teams: motivate, recognize, coach and mentor team members and associates.
- Mentor project management (PM) consultants within post-launch PM. Share learning at PM staff meetings.
- Lead and manage multiple projects teams and/or projects with significant complexity (e.g., external partner, technical transfer to multiple sites, projects with significant regulatory complexity or significant validation issues or requirements).
- Accountable for on time, on spec, and within scope delivery of project milestones through the development of integrated project timelines; actively track leading indicators of team’s progress to major milestones.
- Apply knowledge of project management tools and processes. Drive team decision making process to resolve project issues. Develop a risk management strategy for individual projects and ensure contingency plans are developed. Manage change control process for the scope of the project.
- Evaluate new requests for manufacturing or product changes. Drive development of draft operational plans for proposed new projects and ensures that data are available to allow evaluation of new projects.
- Manage implementation of projects so as to ensure alignment with Business Unit, Regulatory, and Supply Chain partners. Ensure alignment and integration of team activities with quality assurance, quality control, and drive efficient project and submission plans. Manage external partnerships with research and manufacturing organizations as necessary.
- BS or MS in chemistry, pharmacy, or engineering
- 10+ years of experience in more than one CM&C function or manufacturing site
- Demonstrated successful leadership of cross-functional teams
- 3+ years prior project management experience
- Knowledge of the CMC aspects of drug development and manufacturing
- Strong interpersonal and teamwork skills
- Strong self-management and organizational skills
- Oral and written communication skills that demonstrate an ability to effectively (clearly, succinctly) communicate with all levels of the organization
- Consistent demonstration of the performance management leadership behaviors (e.g., model the values, create external focus)
- Experience in Operations, TS/MS, QA or QC, Regulatory or Supply Chain within pharmaceutical manufacturing
- Masters in Project Management, PMP certification, or MBA
Other Information: Some travel (domestic and international) may be required.
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