GMP, Manager

Location
North Carolina, United States
Posted
19 Nov 2018
End of advertisement period
19 Jan 2019
Ref
401506957
Contract Type
Permanent
Hours
Full Time

Job Description

GMP MANAGER

The GMP Portfolio Manager will be responsible for supporting the Duke Human Vaccine Institute (DHVI) GMP Program (DGP) at a strategic level as well as in the day to day project management, evaluation, and scientific progress of the DHVI CGMP Portfolio. The GMP Portfolio Manager will oversee cross functional teams with responsibility for project development, planning, execution, project controls, and risk management across multiple projects. The GMP Portfolio Manager will provide project management coaching and mentorship to all members of the DGP team, and develop junior project management staff to drive continuous improvement required to maintain a rapidly expanding pipeline of products. 

RESPONSIBILITIES:

  1. Design and implement systems tailored for end-to-end portfolio level management of the DGP clinical supply program. Systems design and implementation shall include standard work tools such as agendas, minutes, action trackers, RACI matrices, governance structures, reporting decks, project A3s (strategic / charter / management), financial dashboards, fully integrated resource loaded timelines for all projects in the portfolio, tier processes, and collaborative e-spaces (ex. SharePoint). Utilize change management execution principles for the deployment of new systems / tools.
  2. In collaboration with the DGP team, develop strategic portfolio planning with respect to deliverables, timelines, and budgets. Review resource and staffing requirements for manufacturing campaigns to ensure they align with budget and CGMP facility parameters. Review portfolio budgets to identify current burn rates and identify any budgetary risks, communicating with DHVI leadership and Sponsor, as applicable. Create current and projected multi-year portfolio budgets for future operational planning. 
  3. Collaborate with DHVI and DGP leadership teams and other functions to manage strategic manufacturing initiatives and resource needs.
  4. Oversee a matrixed team responsible to manage and coordinate the pre-award proposal process, working with subject matter experts at various levels in the organization to complete discrete tasks/sections on time and ensure full compliance with all funding solicitation and sponsor requirements.
  5. Oversee a matrixed team responsible to work with the DHVI leadership in the coordination, evaluation, and scientific project management of post award activities for numerous DGP grants/contracts. Monitor portfolio level spending with financial team, liaise with the DGP team to ensure that scientific plans for the portfolio are followed, appropriate deliverables are established and milestones are met.
  6. Oversee a matrixed team responsible to develop and maintain product specific integrated detailed project plans/timelines (Gantt with full work breakdown structure including resource dependencies). The timelines shall be used to effectively identify / communicate interdependencies, as well as critical path activities to manufacturing success.
  7. Use project portfolio to proactively forecast resource planning, process development, documents and ordering schedules, and necessary third party vendor interactions.
  8. Oversee the management of portfolio timelines for all DGP projects and implement corrective actions to ensure risks are proactively identified and mitigated to avoid manufacturing delays. Utilize CGMP expertise to update and communicate modified project plans as necessary with internal and external stakeholders.
  9. Identify problems, escalate early, and facilitate the recommendation of solutions for review and implementation by the team. Facilitate discussion to resolve internal and external issues and escalate issues to DHVI leadership as necessary.
  10. Facilitate team meetings to drive cross-functional communication, timely and effective decision making, and successful execution of project objectives. Effectively communicate with team members, senior leaders, key stakeholders, and subcontractors on the status, objectives, opportunities, risks, and mitigation plans associated with projects. Work to ensure team members are aware of integrated project timelines and the critical path to manufacturing.
  11. Routinely coordinate with stakeholders, internal and external, to provide project updates, develop project plans/risk mitigation plans, disseminate results and coordinate acquisition of materials and services. Develop critical action items list and communicate accordingly. Serve as an external representative of the program to Sponsors and third-party vendors.
  12. Develop direct reports / junior staff to increase overall project management proficiency and expertise within the DGP team.  Coach/mentor DHVI program and project managers as needed to share systems, tools, learnings which have universal application. Routinely seek feedback from stakeholders and peers for continuous improvement.
  13. Perform other duties as assigned by DHVI leadership.

EDUCATION:

Work requires a minimum of a Bachelor’s degree in an engineering or scientific discipline. Master’s or PhD degree preferred; PMP certification is a plus.

EXPERIENCE:

Work requires 8 years of industry experience in a commercial and/or clinical GMP manufacturing environment with proven project management experience at the portfolio level.

KNOWLEDGE, SKILLS, & ABILITIES:

  • Hands-on experience in GMP manufacturing
  • Strong leadership skills with demonstrated ability to collaborate effectively across teams and functions
  • Knowledge and proficiency in project management programs (i.e., MS Project and/or Primavera)
  • In-depth knowledge of project management principles with working knowledge of tools and techniques to project planning, execution, control and risk management
  • Strong verbal and written communication skills
  • Strategic thinking and excellent analytical skills
  • Excellent organizational, time management, and problem solving skills
  • Ability to work well under deadlines and pressure
  • Ability to conduct effective presentations for senior level audiences
  • Ability to prepare and manage budgets
  • Experience in developing and deploying standard work tools for portfolio level project management
  • Experience in leading matrix teams / managing dotted line resources
  • Experience in developing direct reports
  • Skilled in change management execution

Requisition Number 401506957
Location Durham
Duke Entity MEDICAL CENTER
Job Code 3001 GMP, MANAGER
Job Family Level 91
Exempt/Non-Exempt Exempt
Full Time / Part Time FULL TIME
Regular / Temporary Regular
Shift First/Day

Minimum Qualifications

Duke University is an Affirmative Action/Equal Opportunity Employer committed to providing employment opportunity without regard to an individual's age, color, disability, gender, gender expression, gender identity, genetic information, national origin, race, religion, sex,sexual orientation, or veteran status.

Duke aspires to create a community built on collaboration, innovation,creativity, and belonging. Our collective success depends on the robust exchange of ideas—an exchange that is best when the rich diversity of our perspectives, backgrounds, and experiences flourishes. To achieve this exchange, it is essential that all members of the community feel secure and welcome, that the contributions of all individuals are respected, and that all voices are heard. All members of our community have a responsibility to uphold these values.

Essential Physical Job Functions:

Certain jobs at Duke University and Duke University Health System may include essential job functions that require specific physical and/or mental abilities. Additional information and provision for requests for reasonable accommodation will be provided by each hiring department.

Education

Bachelor's degree in a science, engineering, or related field. Advanced degree MS/PhD is highly preferred.

Experience

8 years of experience in the biopharmaceutical or bioprocessindustry or equivalent is required with direct experience in processdevelopment. Previous direct or indirect supervisory experience is a plus.

Auto req ID

105906BR